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D050177: Overwei

Developed by Shray Alag, The Harker School
Sections: Correlations, Clinical Trials, and HPO

Correlations computed by analyzing all clinical trials.

Navigate: Clinical Trials and HPO


Correlated Drug Terms (21)


Name (Synonyms) Correlation
drug166 AZD2693 Wiki 0.33
drug3351 Response and Attention Training Wiki 0.33
drug2641 Nutritional counseling Wiki 0.33
Name (Synonyms) Correlation
drug2884 Phentermine 37.5 Mg Wiki 0.33
drug3100 Project Health Wiki 0.33
drug4617 non-interventional Wiki 0.33
drug2319 Mediterranean diet, no caloric restriction Wiki 0.33
drug1840 Hypocaloric, moderate low fat diet Wiki 0.33
drug1221 Dietary program Wiki 0.33
drug1839 Hypocaloric, low carbohydrate diet Wiki 0.33
drug2137 Lifestyle intervention Wiki 0.33
drug686 CCTP Wiki 0.33
drug1462 Exposure to the Dutch measures due to the Covid-19 pandemic. Wiki 0.33
drug1052 Convalescent Plasma Transfusion Wiki 0.24
drug1446 Exercise program Wiki 0.24
drug1959 Interferon Beta-1A Wiki 0.17
drug1116 Cyclosporine Wiki 0.15
drug1127 DAS181 Wiki 0.14
drug2029 Ivermectin Wiki 0.07
drug1775 Hydroxychloroquine Wiki 0.03
drug2916 Placebo Wiki 0.01

Correlated MeSH Terms (14)


Name (Synonyms) Correlation
D009765 Obesity NIH 0.30
D063766 Pediatric Obesity NIH 0.27
D000073296 Noncommunicable Diseases NIH 0.24
Name (Synonyms) Correlation
D065626 Non-alcoholic Fatty Liver Disease NIH 0.24
D005234 Fatty Liver NIH 0.24
D008659 Metabolic Diseases NIH 0.17
D003327 Coronary Disease NIH 0.13
D003922 Diabetes Mellitus, Type 1 NIH 0.11
D006331 Heart Diseases NIH 0.09
D002908 Chronic Disease NIH 0.09
D002318 Cardiovascular Diseases NIH 0.06
D003920 Diabetes Mellitus, NIH 0.06
D003141 Communicable Diseases NIH 0.02
D007239 Infection NIH 0.02

Correlated HPO Terms (5)


Name (Synonyms) Correlation
HP:0001513 Obesity HPO 0.30
HP:0001397 Hepatic steatosis HPO 0.24
HP:0100651 Type I diabetes mellitus HPO 0.11
Name (Synonyms) Correlation
HP:0000819 Diabetes mellitus HPO 0.06
HP:0001626 Abnormality of the cardiovascular system HPO 0.06

Clinical Trials

Navigate: Correlations   HPO

There are 9 clinical trials


1 Kijk op Overgewicht Bij Kinderen: Study Regarding Etiological Factors, Risk Factors and Early Stages of Chronic Disease in Different Degrees of Childhood Overweight

Children and adolescents with overweight and obesity are predisposed to significant health problems. It is known that childhood obesity can adversely affect almost every organ system, and if left untreated, the major impact of childhood overweight is likely to be felt in the next generation of adults. The aim of " Kijk op overgewicht bij kinderen" is to collect and follow-up longitudinal data from a population of different degrees of children with overweight regarding etiological factors, risk factors and early stages of chronic disease in different degrees of childhood overweight.

NCT02091544
Conditions
  1. Childhood Obesity
Interventions
  1. Other: Lifestyle intervention
MeSH:Pediatric Obesity Overwei Overweight Chronic Disease

Primary Outcomes

Measure: The number of overweight or obese children

Time: approximately 10 years
2 Kijk op Overgewicht Bij Kinderen: Study Regarding Etiological Factors, Risk Factors and Early Stages of Chronic Disease in Different Degrees of Childhood Overweight

Children and adolescents with overweight and obesity are predisposed to significant health problems. It is known that childhood obesity can adversely affect almost every organ system, and if left untreated, the major impact of childhood overweight is likely to be felt in the next generation of adults. The aim of " Kijk op overgewicht bij kinderen" is to collect and follow-up longitudinal data from a population of different degrees of children with overweight regarding etiological factors, risk factors and early stages of chronic disease in different degrees of childhood overweight.

NCT02091544
Conditions
  1. Childhood Obesity
Interventions
  1. Other: Lifestyle intervention
MeSH:Pediatric Obesity Overwei Overweight Chronic Disease

Primary Outcomes

Measure: The number of overweight or obese children

Time: approximately 10 years
3 Accelerating Solutions to Optimize Glycemic Control and Weight Management In Young Adults With Type 1 Diabetes

An initial pilot and feasibility study will be conducted using a Sequential, Multiple Assignment, Randomized Trial (SMART) design to identify acceptable and effective dietary strategies to optimize both glycemic control and weight management in young adults with Type 1 diabetes (T1D). This pilot trial will include a ten-and-a-half month behavioral intervention, with co-primary outcomes of glycemic control (HbA1C and hypoglycemia) and weight loss. The pilot trial will assess acceptability and adherence to three distinct, evidence-based dietary approaches designed to address weight management and glycemic control. Behavioral counseling strategies, use of carbohydrate counting for insulin dosing, and encouragement of physical activity will be the same across the three dietary approaches. COVID-19 PROVISIONS: Due to restrictions in place on in-person visits due to COVID-19 precautions, some subjects may remain in the study longer than 10.5 months. As of June 2020, the study transitioned to a completely virtual format. Those who were due for a measurement visit during the time that research activities were halted, prior to the approval of the virtual procedures, remained on the diet they were currently assigned to, supported by bi-weekly Registered Dietitian (RD) counseling, until they were able to be scheduled for a virtual visit.

NCT03651622
Conditions
  1. Diabetes Mellitus, Type 1
  2. Overweight and Obesity
Interventions
  1. Behavioral: Hypocaloric, low carbohydrate diet
  2. Behavioral: Hypocaloric, moderate low fat diet
  3. Behavioral: Mediterranean diet, no caloric restriction
MeSH:Diabetes Mellitus Diabetes Mellitus, Type 1 Overweight
HPO:Diabetes mellitus Type I diabetes mellitus

Primary Outcomes

Description: Weight in kilograms will be obtained at measurement visits at the beginning and end of this three-and-a-half month time period.

Measure: Change in weight - Randomization 1

Time: Baseline (-14 Days prior to Randomization 1 Visit), 3 Month (Measurement 2) Visit

Description: Weight in kilograms will be obtained at measurement visits at the beginning and end of this three-and-a-half month time period.

Measure: Change in weight - Randomization 2

Time: 3 Month (Measurement 2) Visit, 6.5 Month (Measurement 3) Visit

Description: Weight in kilograms will be obtained at measurement visits at the beginning and end of this three-and-a-half month time period.

Measure: Change in weight - Randomization 3

Time: 6.5 Month (Measurement 3) Visit, 10 Month (Measurement 4) Visit

Description: HbA1c will be measured from a blood sample collected from participants. Blood will be obtained at measurement visits at the beginning and end of this three-and-a-half month time period.

Measure: Change in HbA1C - Randomization 1

Time: Baseline (-14 Days prior to Randomization 1 Visit), 3 Month (Measurement 2) Visit

Description: HbA1c will be measured from a blood sample collected from participants. Blood will be obtained at measurement visits at the beginning and end of this three-and-a-half month time period.

Measure: Change in HbA1C - Randomization 2

Time: 3 Month (Measurement 2) Visit, 6.5 Month (Measurement 3) Visit

Description: HbA1c will be measured from a blood sample collected from participants. Blood will be obtained at measurement visits at the beginning and end of this three-and-a-half month time period.

Measure: Change in HbA1C - Randomization 3

Time: 6.5 Month (Measurement 3) Visit, 10 Month (Measurement 4) Visit

Description: Change in the percent of time spent in hypoglycemia during Continuous Glucose Monitor (CGM) wear time will be assessed between the two weeks of wear from CGM insertion at Baseline Visit (-14 days) and the two weeks of wear from the insertion of the CGM at Measurement Visit 2.

Measure: Difference in Percent Time Spent in Hypoglycemia - Randomization 1

Time: 2 weeks of wear from Baseline Visit (-14 Days), 2 weeks of wear from 3 Month (Measurement 2) Visit

Description: Change in the percent of time spent in hypoglycemia during CGM wear time will be assessed between the two weeks of wear from CGM insertion at Measurement 2 Visit and from CGM insertion at Measurement 3 Visit.

Measure: Difference in Percent Time Spent in Hypoglycemia - Randomization 2

Time: 2 weeks of wear from 3 Month (Measurement 2) Visit, 2 weeks of wear from 6.5 Month (Measurement 3) Visit

Description: Change in the percent of time spent in hypoglycemia during CGM wear time will be assessed between the two weeks of wear from CGM insertion at Measurement 3 Visit and from CGM insertion at Measurement 4 Visit.

Measure: Difference in Percent Time Spent in Hypoglycemia - Randomization 3

Time: 2 weeks of wear from 6.5 Month (Measurement 3) Visit, 2 weeks of wear from 10 Month (Measurement 4) Visit

Secondary Outcomes

Description: Percent fat mass and percent fat free mass will be measured via a dual-energy x-ray absorptiometry (DXA) scan at the beginning and end of this time three-and-a-half-month time period. COVID-19 PROVISIONS: Due to precautions required to prevent the spread of COVID-19, all in-person visits were discontinued as of 3/25/2020. As of this date, DXA scans at both sites were discontinued. Analysis on existing data will continue, but no new DXA data will be collected.

Measure: Change in percent body fat - Randomization 1

Time: Baseline (-14 Days prior to Randomization 1 Visit), 3 Month (Measurement 2) Visit

Description: Percent fat mass and percent fat free mass will be measured via a dual-energy x-ray absorptiometry (DXA) scan at the beginning and end of this three-and-a-half-month time period. COVID-19 PROVISIONS: Due to precautions required to prevent the spread of COVID-19, all in-person visits were discontinued as of 3/25/2020. As of this date, DXA scans at both sites were discontinued. Analysis on existing data will continue, but no new DXA data will be collected.

Measure: Change in percent body fat - Randomization 2

Time: 3 Month (Measurement 2) Visit, 6.5 Month (Measurement 3) Visit

Description: Percent fat mass and percent fat free mass will be measured via a dual-energy x-ray absorptiometry (DXA) scan at the beginning and end of this three-and-a-half-month time period. COVID-19 PROVISIONS: Due to precautions required to prevent the spread of COVID-19, all in-person visits were discontinued as of 3/25/2020. As of this date, DXA scans at both sites were discontinued. Analysis on existing data will continue, but no new DXA data will be collected.

Measure: Change in percent body fat - Randomization 3

Time: 6.5 Month (Measurement 3) Visit, 10 Month (Measurement 4) Visit

Description: Change in percent of time spent in a pre-defined range of relative euglycemia (for a person with Type 1 diabetes) during CGM wear time, will be assessed between the two weeks of wear from CGM insertion at Baseline Visit (-14 days) and the two weeks of wear from CGM insertion at Measurement Visit 2.

Measure: Difference in time spent within target blood glucose range - Randomization 1

Time: 2 weeks of wear from 3 Month (Measurement 2) Visit, 2 weeks of wear from 6.5 Month (Measurement 3) Visit

Description: Change in percent of time spent in a pre-defined range of relative euglycemia (for a person with Type 1 diabetes) during CGM wear time, will be assessed between the two weeks of wear from CGM insertion at Measurement 2 Visit and from CGM insertion at Measurement 3 Visit.

Measure: Difference in time spent within target blood glucose range - Randomization 2

Time: 2 weeks of wear from 3 Month (Measurement 2) Visit, 2 weeks of wear from 6.5 Month (Measurement 3) Visit

Description: Change in percent of time spent in a pre-defined range of relative euglycemia (for a person with Type 1 diabetes) during CGM wear time, will be assessed between the two weeks of wear from CGM insertion at Measurement 3 Visit and from CGM insertion at Measurement 4 Visit.

Measure: Difference in time spent within target blood glucose range - Randomization 3

Time: 2 weeks of wear from 6.5 Month (Measurement 3) Visit, 2 weeks of wear from 10 Month (Measurement 4) Visit
4 Enhancing Effectiveness of a Dissonance-Based Obesity Prevention Program

This project seeks to improve the effectiveness of a novel dissonance-based obesity prevention program that has reduced future BMI gain and overweight/obesity onset by (a) experimentally testing whether implementing it in single- versus mixed-sex groups, which should increase dissonance-induction that contributes to weight gain prevention effects, and (b) experimentally testing whether adding food response and attention training, which theoretically reduces valuation of and attention for high-calorie foods, increases weight gain prevention effects. This randomized trial would be the first to experimentally manipulate these two factors in an effort to produce superior weight gain prevention effects. A brief effective obesity prevention program that can be easily, inexpensively, and broadly implemented to late adolescents at risk for excess weight gain, as has been the case with another dissonance-based prevention program, could markedly reduce the prevalence of obesity and associated morbidity and mortality.

NCT03710746
Conditions
  1. Overweight and Obesity
Interventions
  1. Behavioral: Project Health
  2. Behavioral: Response and Attention Training
MeSH:Obesity Overweight
HPO:Obesity

Primary Outcomes

Description: Change in percentage of body fat (Not collected during COVID-19 shelter-at-home order)

Measure: Body Fat

Time: Baseline, 2 months, 8 months, 14 months, 26 months, and 38 months

Description: Change in BMI (Not collected during COVID-19 shelter-at-home order)

Measure: Body Mass Index (BMI)

Time: Baseline, 2 months, 8 months, 14 months, 26 months, and 38 months

Secondary Outcomes

Description: Change in weight concerns. Scale scores range from 0 to 42 with higher scores being indicative of higher weight concerns.

Measure: Weight Concerns Scale from the Eating Disorder Examination Questionnaire (EDE-Q)

Time: Baseline, 2 months, 8 months, 14 months, 26 months, and 38 months

Description: Change in depressive symptoms

Measure: Beck Depression Index (BDI)

Time: Baseline, 2 months, 8 months, 14 months, 26 months, and 38 months

Description: Change in eating disorder symptoms

Measure: Eating Disorder Interview (EDDI)

Time: Baseline, 2 months, 8 months, 14 months, 26 months, and 38 months
5 Evaluating the Impact of a Culinary Coaching Telemedicine Program on Body Weight and Metabolic Outcomes - A Randomized Controlled Trial

Introduction: Obesity is a major public health problem and adopting healthy lifestyle habits, while effective, is challenging in real-world settings. Culinary coaching is a behavioral intervention that aims to improve nutrition and overall health by facilitating home cooking through an active learning process that combines culinary training and health coaching. Our goal is to evaluate whether a culinary coaching telemedicine program (twelve 30-minute sessions) will significantly improve outcomes among subjects with overweight or obesity. General hypothesis: A culinary coaching telemedicine program will result in significant weight loss, and improvement in culinary attitude and self-efficacy, nutritional intake, and metabolic outcomes. Methods: This is a two-site, 36-month randomized controlled trial in which study participants between the ages of 25 to 70, with 27.5 ≤ BMI ≤ 35 Kg/m2 will be randomly assigned to nutritional counseling combined with a structured culinary coaching program or to nutritional counseling group (18 intervention, 18 control at each site). Intervention will include a 3-month culinary coaching telemedicine program with outcome data collected periodically for 12 months. The pre-defined primary outcome is body weight loss at 6 months, and secondary outcomes include change in body weight and composition at 1 year, as well as culinary attitudes and self-efficacy through a validated questionnaire, nutritional intake, lipid profile, blood pressure, and HgA1c (glycated hemoglobin); and participants' perception of the program. Potential impact: The investigators believe that this program has a potential to be a viable tool in promoting effective and scalable home cooking interventions aimed at improved nutrition and health outcomes in overweight and obesity.

NCT03823469
Conditions
  1. Overweight
  2. Obesity
Interventions
  1. Behavioral: CCTP
  2. Behavioral: Nutritional counseling
MeSH:Overweight

Primary Outcomes

Description: 5% decrease in body weight (kg) in the intervention arm as compared to control. measured by a registered dietitian.

Measure: Body weight at 6 months

Time: Six months

Secondary Outcomes

Description: Body weight (kg), measured by a registered dietitian

Measure: Body weight

Time: Body weight will be obtained at baseline, after the intervention (at 3 months), 6 months after the beginning of the intervention, and 12 months after the beginning of the intervention

Description: Culinary attitudes and self-efficacy will be evaluated by the Cooking With a Chef (CWC) Instrument. This is a 22-item self-administered Likert scale questionnaire that generates three subscales: 1) the cooking techniques and meal preparation self-efficacy subscale (14 items; 1 - not al all confident; 5- extremely confident; sub-scale range 14-70), 2) the negative cooking attitudes subscale (4 items; 1 - strongly disagree; 5 - strongly agree; sub-scale range 4-20), and, 3) the self-efficacy to consume fruit and vegetables subscale (5 items; 1 - not al all confident; 5- extremely confident; sub-scale range 5-25).

Measure: Culinary attitude & self-efficacy

Time: Culinary attitude & self-efficacy will be obtained at baseline, after the intervention (at 3 months), 6 months after the beginning of the intervention, and 12 months after the beginning of the intervention

Description: Nutritional intake will be evaluated by a 4-day food record. Intake will be analyzed for its caloric content (kcal), saturated fats(g), trans fats(g), legumes (g), fruits (g), red and processed meat (g), sugars(g), processed food(g), vegetables(g), soft drinks(g), fish(g), whole grain(g), refined grain(g), and monounsaturated fat-saturated fat ratio. Vegetables, legumes, fruits, nuts, whole grains, fish, monounsaturated fat-saturated fat ratio, alcohol, and meat will be aggregate to report Mediterranean index in points (1-9))

Measure: Nutritional intake

Time: Nutritional intake will be obtained at baseline, after the intervention (at 3 months), 6 months after the beginning of the intervention, and 12 months after the beginning of the intervention

Description: Adherence to Mediterranean Diet will be evaluated by the validated 14 items Questionnaire of Mediterranean Diet Adherence, extracted by a dietitian from a 4-day food record (0 - low adherence; 14 - high adherence)

Measure: Adherence to Mediterranean Diet

Time: Nutritional intake will be obtained at baseline, after the intervention (at 3 months), 6 months after the beginning of the intervention, and 12 months after the beginning of the intervention

Description: Consumption of ultra-processed food will be evaluated by the NOVE food classification, extracted by a dietitian from a 4-day food record (unprocessed or minimally processed foods (g), processed culinary ingredients (g), processed foods (g), ultra processed foods (g))

Measure: Consumption of ultra-processed

Time: Nutritional intake will be obtained at baseline, after the intervention (at 3 months), 6 months after the beginning of the intervention, and 12 months after the beginning of the intervention

Description: blood pressure (both systolic and diastolic), measured in a seated position by a nurse using a sphygmometer

Measure: Blood pressure

Time: Blood pressure will be obtained at baseline, after the intervention (at 3 months), 6 months after the beginning of the intervention, and 12 months after the beginning of the intervention

Description: Lipid profile (total cholesterol, HDL-cholesterol, LDL-cholesterol, non-HDL cholesterol and triglycerides), measured from a blood sample drawn

Measure: Lipid profile

Time: Lipid profile will be obtained at baseline, after the intervention (at 3 months), 6 months after the beginning of the intervention, and 12 months after the beginning of the intervention

Description: HbA1c, measured from a blood sample drawn

Measure: HbA1c

Time: HbA1c will be obtained at baseline, after the intervention (at 3 months), 6 months after the beginning of the intervention, and 12 months after the beginning of the intervention

Description: Lean body mass (g) will measured using Bone Densitometry

Measure: Lean body mass

Time: Lean body mass will be obtained at baseline, and at 6 months after the beginning of the intervention

Description: Total fat mass (g, %fat) will measured using Bone Densitometry

Measure: Total fat mass

Time: Total fat mass will be obtained at baseline, and at 6 months after the beginning of the intervention

Description: Trunk fat mass (g, %fat) will measured using Bone Densitometry

Measure: Trunk fat mass

Time: Trunk fat mass will be obtained at baseline, and at 6 months after the beginning of the intervention

Description: Fat distribution will measured using Bone Densitometry. Measurements includes: android fat mass (g, %fat) and gynoid fat mass (g, %fat). Fat distribution will be extracted from Android/ Gynoid

Measure: Fat distribution

Time: Body composition will be obtained at baseline, and at 6 months after the beginning of the intervention

Description: Stages of change in relation to home cooking as assessed by the validated University of Rod Island Change Assessment (URICA) Scale. This is a 32-item self-administered Likert scale questionnaire (1 - strongly disagree; 5 - strongly agree). Minimum score - 32, maximum score - 160

Measure: Stages of change in relation to home cooking

Time: Stages of change will be obtained at baseline, after the intervention (at 3 months), 6 months after the beginning of the intervention, and 12 months after the beginning of the intervention

Description: Perceived Stress, evaluated by the validated Perceived Stress Scale. This is a 10-item self-administered Likert scale questionnaire (0 - never; 4 - very often). Minimum score - 0, maximum score - 10.

Measure: Perceived Stress

Time: Perceived stress will be obtained at baseline, after the intervention (at 3 months), 6 months after the beginning of the intervention, and 12 months after the beginning of the intervention

Description: Information about subjects' experiences (e.g., feelings during the CCTP; difficulties, dilemmas, and challenges during the program) will be evaluated using a structured open-ended questionnaire.

Measure: Subject perceptions of the program

Time: subjects perception of the program will be obtained using open ended questionnaires at baseline, 6 months after the beginning of the intervention, and 12 months after the beginning of the intervention

Description: Information about subjects' experiences (e.g., feelings during the CCTP; difficulties, dilemmas, and challenges during the program) will be evaluated using In-depth semi-structured interview.

Measure: Subject perceptions of the program

Time: Subjects perception of the program will be obtained using in-depth interview after the intervention (at 3 months).

Description: Overall resiliency to cope with the COVID-19 epidemic with be obtained through the Brief Resilient Coping Scale and copying strategies through the Brief Cope scale

Measure: Coping with Stress

Time: Coping with stress will be obtain through the 2 months of the pick COVID-19 epidemic
6 A Phase I, Randomized, Single-blind, Placebo-controlled Study to Assess the Safety, Tolerability and Pharmacokinetics of AZD2693 Following Single Ascending Dose Administration in Male and Female Subjects of Non-childbearing Potential in Overweight But Otherwise Healthy Subjects, and Healthy Chinese and Japanese Subjects

This Phase 1, first-in-human (FiH), single-ascending-dose (SAD) study, will assess the safety and tolerability and characterize the pharmacokinetics (PK) of AZD2693, following subcutaneous (SC) SAD administration of AZD2693 in male and female subjects of non-childbearing potential in overweight but otherwise healthy subjects, and healthy Chinese and Japanese subjects.

NCT04142424
Conditions
  1. Metabolic Disorders
  2. Non-alcoholic Steatohepatitis
Interventions
  1. Drug: AZD2693
  2. Drug: Placebo
MeSH:Fatty Liver Non-alcoholic Fatty Liver Disease Metabolic Diseases Overweight
HPO:Hepatic steatosis

Primary Outcomes

Description: To investigate the safety and tolerability of SC administration of SAD of AZD2693

Measure: Number of subjects experiencing adverse events and serious adverse events

Time: From baseline (Day 1) until Day 112 (Week 16, Final follow-up)

Secondary Outcomes

Description: To characterize the PK of AZD2693 following SC administration of SAD of AZD2693

Measure: Area under the concentration-time curve from time zero extrapolated to infinity (AUC)

Time: At Day 1 pre-dose, 0.25 hours [h], 0.5h, 1h, 1.5h, 2h, 2.5h, 3h, 4h, 5h, 6h, 8h, 12h, 24h, 36h, 48h and 72h post-dose and 1, 2, 4, 8, 12 and 16 weeks post-dose

Description: To characterize the PK of AZD2693 following SC administration of SAD of AZD2693

Measure: Area under the plasma concentration-time curve from time zero to 48 hours after dosing [AUC(0-48h)]

Time: At Day 1 pre-dose, 0.25h, 0.5h, 1h, 1.5h, 2h, 2.5h, 3h, 4h, 5h, 6h, 8h, 12h, 24h, 36h, 48h and 72h post-dose and 1, 2, 4, 8, 12 and 16 weeks post-dose

Description: To characterize the PK of AZD2693 following SC administration of SAD of AZD2693

Measure: Area under the plasma concentration-time curve from time zero to time of last quantifiable analyte concentration divided by the dose administered (AUClast/D)

Time: At Day 1 pre-dose, 0.25h, 0.5h, 1h, 1.5h, 2h, 2.5h, 3h, 4h, 5h, 6h, 8h, 12h, 24h, 36h, 48h and 72h post-dose and 1, 2, 4, 8, 12 and 16 weeks post-dose

Description: To characterize the PK of AZD2693 following SC administration of SAD of AZD2693

Measure: Area under the plasma concentration-curve from time zero to the time of last quantifiable analyte concentration (AUClast)

Time: At Day 1 pre-dose, 0.25h, 0.5h, 1h, 1.5h, 2h, 2.5h, 3h, 4h, 5h, 6h, 8h, 12h, 24h, 36h, 48h and 72h post-dose and 1, 2, 4, 8, 12 and 16 weeks post-dose

Description: To characterize the PK of AZD2693 following SC administration of SAD of AZD2693

Measure: Area under the plasma concentration-time curve from time zero extrapolated to infinity divided by the dose administered (AUC/D)

Time: At Day 1 pre-dose, 0.25h, 0.5h, 1h, 1.5h, 2h, 2.5h, 3h, 4h, 5h, 6h, 8h, 12h, 24h, 36h, 48h and 72h post-dose and 1, 2, 4, 8, 12 and 16 weeks post-dose

Description: To characterize the PK of AZD2693 following SC administration of SAD of AZD2693

Measure: Maximum observed plasma drug concentration (Cmax) of AZD2693

Time: At Day 1 pre-dose, 0.25h, 0.5h, 1h, 1.5h, 2h, 2.5h, 3h, 4h, 5h, 6h, 8h, 12h, 24h, 36h, 48h and 72h post-dose and 1, 2, 4, 8, 12 and 16 weeks post-dose

Description: To characterize the PK of AZD2693 following SC administration of SAD of AZD2693

Measure: Observed maximum plasma concentration divided by the dose administered (Cmax/D)

Time: At Day 1 pre-dose, 0.25h, 0.5h, 1h, 1.5h, 2h, 2.5h, 3h, 4h, 5h, 6h, 8h, 12h, 24h, 36h, 48h and 72h post-dose and 1, 2, 4, 8, 12 and 16 weeks post-dose

Description: To characterize the PK of AZD2693 following SC administration of SAD of AZD2693

Measure: Time to reach maximum observed concentration following drug administration (tmax)

Time: At Day 1 pre-dose, 0.25h, 0.5h, 1h, 1.5h, 2h, 2.5h, 3h, 4h, 5h, 6h, 8h, 12h, 24h, 36h, 48h and 72h post-dose and 1, 2, 4, 8, 12 and 16 weeks post-dose

Description: To characterize the PK of AZD2693 following SC administration of SAD of AZD2693.

Measure: Apparent terminal elimination half-life associated with the terminal slope (λz) of the semi-logarithmic concentration-time curve, estimated as (ln2)/λz (t½λz)

Time: At Day 1 pre-dose, 0.25h, 0.5h, 1h, 1.5h, 2h, 2.5h, 3h, 4h, 5h, 6h, 8h, 12h, 24h, 36h, 48h and 72h post-dose and 1, 2, 4, 8, 12 and 16 weeks post-dose

Description: To characterize the PK of AZD2693 following SC administration of SAD of AZD2693

Measure: Apparent total body clearance of drug from plasma after extravascular administration calculated as Dose/AUC (CL/F)

Time: At Day 1 pre-dose, 0.25h, 0.5h, 1h, 1.5h, 2h, 2.5h, 3h, 4h, 5h, 6h, 8h, 12h, 24h, 36h, 48h and 72h post-dose and 1, 2, 4, 8, 12 and 16 weeks post-dose

Description: To characterize the PK of AZD2693 following SC administration of SAD of AZD2693

Measure: Apparent volume of distribution for parent drug at terminal phase (extravascular administration), estimated by dividing CL/F by λz (Vz/F)

Time: At Day 1 pre-dose, 0.25h, 0.5h, 1h, 1.5h, 2h, 2.5h, 3h, 4h, 5h, 6h, 8h, 12h, 24h, 36h, 48h and 72h post-dose and 1, 2, 4, 8, 12 and 16 weeks post-dose

Description: To characterize the PK of AZD2693 following SC administration of SAD of AZD2693

Measure: Mean residence time (MRT)

Time: At Day 1 pre-dose, 0.25h, 0.5h, 1h, 1.5h, 2h, 2.5h, 3h, 4h, 5h, 6h, 8h, 12h, 24h, 36h, 48h and 72h post-dose and 1, 2, 4, 8, 12 and 16 weeks post-dose

Description: To characterize the PK of AZD2693 following SC administration of SAD of AZD2693

Measure: Terminal elimination rate constant, estimated by log-linear least-squares regression of the terminal part of the concentration-time curve (λz)

Time: At Day 1 pre-dose, 0.25h, 0.5h, 1h, 1.5h, 2h, 2.5h, 3h, 4h, 5h, 6h, 8h, 12h, 24h, 36h, 48h and 72h post-dose and 1, 2, 4, 8, 12 and 16 weeks post-dose

Description: To characterize the PK of AZD2693 following SC administration of SAD of AZD2693

Measure: Time delay between drug administration and the first observed concentration in plasma (tlag)

Time: At Day 1 pre-dose, 0.25h, 0.5h, 1h, 1.5h, 2h, 2.5h, 3h, 4h, 5h, 6h, 8h, 12h, 24h, 36h, 48h and 72h post-dose and 1, 2, 4, 8, 12 and 16 weeks post-dose

Description: To characterize the PK of AZD2693 following SC administration of SAD of AZD2693

Measure: Time of the last quantifiable concentration (tlast)

Time: At Day 1 pre-dose, 0.25h, 0.5h, 1h, 1.5h, 2h, 2.5h, 3h, 4h, 5h, 6h, 8h, 12h, 24h, 36h, 48h and 72h post-dose and 1, 2, 4, 8, 12 and 16 weeks post-dose

Description: To characterize the PK of AZD2693 following SC administration of SAD of AZD2693

Measure: Cumulative fraction (%) of dose excreted unchanged into the urine from time zero to the last measured time point [fe(0-last)]

Time: At Day 1 pre-dose, 0-6h, 6-12h and then 0-12h intervals up to 72h post-dose

Description: To characterize the PK of AZD2693 following SC administration of SAD of AZD2693

Measure: Cumulative amount of analyte excreted into the urine from time zero through the last sampling interval [Ae(0-last)]

Time: At Day 1 pre-dose, 0-6h, 6-12h and then 0-12h intervals up to 72h post-dose

Description: To characterize the PK of AZD2693 following SC administration of SAD of AZD2693

Measure: Renal clearance of drug from plasma, estimated by dividing Ae(0-t) by AUC(0-t) where the 0-t interval is the same for both Ae and AUC [CLR]

Time: At Day 1 pre-dose, 0-6h, 6-12h and then 0-12h intervals up to 72h post-dose

Description: To characterize the PK of AZD2693 following SC administration of SAD of AZD2693

Measure: Amount of analyte excreted into the urine from time t1 to t2 [Ae(t1-t2)]

Time: At Day 1 pre-dose, 0-6h, 6-12h and then 0-12h intervals up to 72h post-dose

Description: To characterize the PK of AZD2693 following SC administration of SAD of AZD2693

Measure: Fraction of dose excreted unchanged into the urine from time t1 to t2 [fe(t1-t2)]

Time: At Day 1 pre-dose, 0-6h, 6-12h and then 0-12h intervals up to 72h post-dose
7 The Influence of the Covid-19 Pandemia on the Health Behaviour of Primary School Children (and Their Parents) - COVID-19, Obesity and Lifestyle in Children

This study aims to evaluate the impact of the COVID-19 pandemic and its measures on lifestyle in Dutch children between 4 - 18 years.

NCT04411511
Conditions
  1. Covid-19
  2. Obesity, Childhood
  3. Lifestyle
  4. Lifestyle, Healthy
  5. Overweight, Childhood
  6. Children, Only
  7. Family
Interventions
  1. Other: Exposure to the Dutch measures due to the Covid-19 pandemic.
MeSH:Obesity Pediatric Obesity Overweight
HPO:Obesity

Primary Outcomes

Description: Weight development of the child. Weight (in kg) will be measured using scales at home, with clear instructions.

Measure: Change in weight child

Time: Every 2 weeks until end of the Dutch governement measures affecting children (e.g. fully opening of the schools and sportclubs). Three months after the "measures"-period, 1 follow-up moment.

Description: Weight development of the parents. Weight (in kg) will be measured using scales at home, with clear instructions.

Measure: Change in weight parents

Time: Every 2 weeks until end of the Dutch governement measures affecting children (e.g. fully opening of the schools and sportclubs, hereafter: "coronacrisis-period"). Three months after the "measures"-period, 1 follow-up moment.

Secondary Outcomes

Description: eating behaviour during measures due to the coronacrisis, measured with an online questionnaire.

Measure: Eating behaviour

Time: Every month until end of the Dutch governement measures affecting children (e.g. fully opening of the schools and sportclubs). Three months after the "measures"-period, 1 follow-up moment.

Description: COVID-19 related symptoms and adherence to governmental measures, measured with an online questionnaire.

Measure: Symptoms

Time: Every 2 weeks until end of the Dutch governement measures affecting children (e.g. fully opening of the schools and sportclubs). Three months after the "measures"-period, 1 follow-up moment.

Description: Daystructure of children during the coronacrisis, measured with an online questionnaire.

Measure: Day structure

Time: Every month until end of the Dutch governement measures affecting children (e.g. fully opening of the schools and sportclubs). Three months after the "measures"-period, 1 follow-up moment.

Description: Physical activity behaviour children during the coronacrisis, measured with the Baecke questionnaire.

Measure: Physical activity

Time: Every month until end of the Dutch governement measures affecting children (e.g. fully opening of the schools and sportclubs). Three months after the "measures"-period, 1 follow-up moment.

Description: Screentime during the the coronacrisis, measured with an online questionnaire.

Measure: Screentime

Time: Every month until end of the Dutch governement measures affecting children (e.g. fully opening of the schools and sportclubs). Three months after the "measures"-period, 1 follow-up moment.

Description: Online possibilities for working on a healthy lifestyle, such as challenges regarding nutrition and physical activity, measured with an online questionnaire.

Measure: Online possibilities

Time: Every month until end of the Dutch governement measures affecting children (e.g. fully opening of the schools and sportclubs). Three months after the "measures"-period, 1 follow-up moment.

Description: Quality of life during the coronacrisis, measured with the Kidscreen-27.

Measure: Quality of life in children

Time: Once in first month of the study and once within three months after COVID-19 measures are scaled down.

Description: Parenting practices regarding eating behaviour and physical activity, measured with a questionnaire.

Measure: Parenting practices

Time: Once in first month of the study and once within three months after COVID-19 measures are scaled down.

Other Outcomes

Description: Qualitative data on lifestyle in children during the coronacrisis, by semi-structured interviews.

Measure: Qualitative data on lifestyle in children

Time: Up to approximately 1 year
8 Analysis of Chronic Non-infectious Diseases Dynamics After COVID-19 Infection in Adult Patients

Non-commercial depersonalized multi-centered registry study on analysis of chronic non-infectious diseases dynamics after SARS-CoV-2 infection in adults.

NCT04492384
Conditions
  1. Covid19
  2. SARS-CoV-2 Infection
  3. Pneumonia
  4. Copd
  5. CKD
  6. Cardiac Event
  7. Overweight and Obesity
  8. Cardiovascular Diseases
  9. Diabetes
  10. Hypertension
  11. Coronary Heart Disease
Interventions
  1. Other: non-interventional
MeSH:Infection Communicable Diseases Cardiovascular Diseases Heart Diseases Coronary Disease Overweight Noncommunicable Diseases
HPO:Abnormality of the cardiovascular system

Primary Outcomes

Description: percentage of patients with non-infectious diseases relating to overall number of patients registered in study

Measure: rate of non-infectious diseases

Time: 12 month since a moment of request of medical help

Description: correlation between number of patients with COVID-19 of various severity and number of pre-existing conditions and their severity among these groups

Measure: severity of COVID-19 depending on pre-existing diseases

Time: 12 month since a moment of request of medical help

Description: Registration of disability or change of disability status

Measure: disability registration / change of disability status

Time: 12 month since a moment of request of medical help

Description: rate of deaths among registered participants

Measure: rate of letal outcomes

Time: 12 month since a moment of request of medical help

Description: correlation between number of deaths and pre-existing diseases

Measure: rate of letal outcomes depending on pre-existing disease

Time: 12 month since a moment of request of medical help
9 The Use of a Virtual Weight Management Program for Prescription of Phentermine in Patients With Overweight or Obesity Compared to Standard Face to Face Visits

This study will study the effects associated with the prescription of phentermine in a virtual setting, comparing with prescription of phentermine via a standard face-to-face visit for patients with obesity or overweight.

NCT04614545
Conditions
  1. Obesity
Interventions
  1. Drug: Phentermine 37.5 Mg
  2. Behavioral: Dietary program
  3. Behavioral: Exercise program
MeSH:Obesity Overweight
HPO:Obesity

Primary Outcomes

Description: The primary endpoint is mean change in body weight (%) from baseline (visit 1) to 12 weeks (visit 4) in body weight.

Measure: Change in body weight (percentage)

Time: 12 weeks

Secondary Outcomes

Description: Assessed as number of missed visits

Measure: Adherence to weight management program

Time: 12 weeks

Description: Assessment of medication compliance

Measure: Adherence to medication use

Time: 12 weeks

Description: Mean change in BMI from baseline to week 12

Measure: Change in BMI

Time: 12 weeks

HPO Nodes


HPO

Alphabetical listing of all HPO terms. Navigate: Correlations   Clinical Trials


HPO Nodes


Reports

Data processed on September 26, 2020.

An HTML report was created for each of the unique drugs, MeSH, and HPO terms associated with COVID-19 clinical trials. Each report contains a list of either the drug, the MeSH terms, or the HPO terms. All of the terms in a category are displayed on the left-hand side of the report to enable easy navigation, and the reports contain a list of correlated drugs, MeSH, and HPO terms. Further, all reports contain the details of the clinical trials in which the term is referenced. Every clinical trial report shows the mapped HPO and MeSH terms, which are also hyperlinked. Related HPO terms, with their associated genes, protein mutations, and SNPs are also referenced in the report.

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