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D024821: Metabolic Syndrome

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 (11)


Name (Synonyms) Correlation
drug3134 Performance of WHEELS-I in promoting DASH/SRD adoption Wiki 0.38
drug5051 metformin glycinate Wiki 0.38
drug3055 PP-MI Intervention Wiki 0.38
Name (Synonyms) Correlation
drug548 Balance exercise Wiki 0.38
drug2897 Nutritional education Wiki 0.38
drug1235 DPPFit Wiki 0.38
drug1457 Effects of a 2-week DASH/SRD intervention vs. control diet on HFpEF functional cardiovascular risk factors Wiki 0.38
drug4671 Virtual ELM Wiki 0.38
drug4330 Telerehabilitation Wiki 0.19
drug4092 Standard care Wiki 0.12
drug3273 Placebo oral tablet Wiki 0.06

Correlated MeSH Terms (7)


Name (Synonyms) Correlation
D018149 Glucose Intolerance NIH 0.22
D011236 Prediabetic State NIH 0.19
D013577 Syndrome NIH 0.13
Name (Synonyms) Correlation
D006333 Heart Failure NIH 0.09
D003924 Diabetes Mellitus, Type 2 NIH 0.08
D045169 Severe Acute Respiratory Syndrome NIH 0.02
D018352 Coronavirus Infections NIH 0.01

Correlated HPO Terms (2)


Name (Synonyms) Correlation
HP:0001635 Congestive heart failure HPO 0.09
HP:0005978 Type II diabetes mellitus HPO 0.08

Clinical Trials

Navigate: Correlations   HPO

There are 7 clinical trials


1 Metabolic Syndrome and Fall Risk

Obesity and the metabolic syndrome (MetS) are rapidly growing problems. Individuals with the MetS are at risk for not only future chronic diseases, but they have a higher prevalence of neuropathy, including cardiac autonomic neuropathy, and have a higher incidence of falls. Currently there are no effective therapies to prevent or reverse the neuropathy seen in the MetS or to reduced the fall risk in this population. This research project will determine if a tailored balance exercise program will have functional benefits and result in a reduced fall risk in the growing population of patients with the MetS and neuropathy.

NCT02633891
Conditions
  1. Metabolic Syndrome
  2. Autonomic Neuropathy
Interventions
  1. Behavioral: Balance exercise
  2. Behavioral: Standard care
MeSH:Metabolic Syndrome Syndrome

Primary Outcomes

Description: A measure of proactive dynamic standing balance. A participant steps over four canes that are laid on the ground at 90 degree angles to each other. The participants stands in one of the squares formed by the canes and they are instructed to step as quickly as possible into each square in a specified sequence.

Measure: Four Square Step Test (FSST)

Time: 12 weeks

Secondary Outcomes

Description: An instrumented DGI will be performed on an instrumented gait mat. The DGI is a measure of functional balance during walking an it assesses an individual's ability to modify balance while walking in the presence of external demands (walking while changing speeds, head turns, stepping over and around obstacles, pivoting, and stair climbing).

Measure: Dynamic Gait Index (DGI)

Time: 12 weeks
2 Dietary Prevention of Heart Failure in Hypertensive Metabolic Syndrome

Tens of thousands of Veterans have heart failure with preserved ejection fraction (HFpEF), and suffer poor quality of life, frequent hospitalizations, and high death rates. Older Veterans and those with high blood pressure, obesity, and the metabolic syndrome (abnormal cholesterol and resistance to insulin's effects) are particularly at risk for HFpEF. However, it is not clear why only some Veterans in this risk group eventually develop HFpEF. Extensive information from experimental animal models and some human studies suggests that dietary patterns in vulnerable 'salt-sensitive' people could contribute to the risk for HFpEF. Reducing salt intake and increasing overall dietary quality in at-risk Veterans could prevent heart and blood vessel damage that ultimately leads to HFpEF. Reducing the development of HFpEF, which currently has no definitive treatment, is highly relevant to the VA's mission to emphasize prevention of disease and population health.

NCT03170375
Conditions
  1. Heart Failure
Interventions
  1. Behavioral: Performance of WHEELS-I in promoting DASH/SRD adoption
  2. Behavioral: Effects of a 2-week DASH/SRD intervention vs. control diet on HFpEF functional cardiovascular risk factors
MeSH:Heart Failure Metabolic Syndrome
HPO:Abnormal left ventricular function Congestive heart failure Right ventricular failure

Primary Outcomes

Description: Velocity of pulse wave traveling between carotid and femoral artery; validated measure of arterial stiffness

Measure: Carotid-femoral pulse wave velocity

Time: Phase 1 of study, change from baseline at the end of week 2 and week 4

Description: Left ventricular mass indexed to height

Measure: Left ventricular mass index

Time: Phase 2 of study, change from baseline to 6 months

Secondary Outcomes

Description: Ventricular stiffness k, by Parametrized Diastolic Formalism analysis

Measure: Ventricular stiffness

Time: Phase 1 of study, change from baseline at the end of week 2 and week 4

Description: Global longitudinal left ventricular strain, a sensitive measure of ventricular systolic function

Measure: Global longitudinal left ventricular strain

Time: Phase 1 of study, change from baseline at the end of week 2 and week 4

Description: Global left atrial strain, a novel measure of atrial function

Measure: Global left atrial strain

Time: Phase 1 of study, change from baseline at the end of week 2 and week 4

Description: Velocity of pulse wave traveling between carotid and femoral artery; validated measure of arterial stiffness

Measure: Carotid-femoral pulse wave velocity

Time: Phase 2 of study, change from baseline to 6 months

Description: Left atrial volume by 3D echocardiography

Measure: Left atrial volume

Time: Phase 2 of study, change from baseline to 6 months

Other Outcomes

Description: Change in 24-hour mean of >= 8 mmHg will define the salt-sensitive blood pressure phenotype

Measure: Salt-sensitivity phenotype

Time: Phase 1 of study, change from baseline at the end of week 2 and week 4

Description: Measure of dietary sodium intake

Measure: 24-hour urinary sodium excretion

Time: Phase 2 of study, change from baseline to 6 months

Description: Sodium-restricted DASH diet score on Food Frequency Questionnaire, measured by complete or partial adherence to 9 dietary domains

Measure: Sodium-restricted DASH diet adherence

Time: Phase 2 of study, change from baseline to 6 months

Description: Analysis of 3-day food diaries by a Registered Dietitian, utilizing the Nutrition Data System for Research

Measure: Sodium-restricted DASH diet adherence

Time: Phase 2 of study, months 1 and 6
3 Developing a Positive Psychology Intervention to Promote Health Behaviors in Metabolic Syndrome: A Randomized Controlled Pilot Trial

Specific Aim #1 (Feasibility; primary aim): To assess the feasibility of the PP-MI group-based physical activity intervention and outcome assessments in patients with MetS. Hypothesis: The PP exercises and MI-based goal-setting sessions will be feasible: most (≥50%) of participants will complete 6/9 exercises/sessions. Furthermore, the investigators will be able to obtain objective physical activity measurement follow-up data from at least 80% of enrolled participants at the end of the intervention and 24 weeks later. Specific Aim #2 (Acceptability): To assess whether the intervention is acceptable to participants, as measured by ratings provided after each PP-MI session. Hypothesis: The intervention will be acceptable: participants will rate the PP-MI exercises with a mean score of at least 7 out of 10 on ease of completion and helpfulness. Specific Aim #3 (Outcomes): To assess whether this preliminary intervention appears to result in improvement of physical activity, related health behaviors (sedentary time, diet quality), psychological well-being (optimism, positive affect, anxiety, depression), and the exploratory outcomes of MetS-relevant physiological markers (e.g., blood pressure, weight, chart-reviewed lipids and HbA1C). Hypothesis a: The intervention will lead to improvements in physical activity, related health behaviors, optimism and positive affect, reductions in depression and anxiety at 9 weeks and 24 weeks compared to baseline (or the start of the intervention, for the WLC group). Hypothesis b: The hypothesis is that there will be improvements in the exploratory outcomes of the physiological markers, even if they do not reach significance.

NCT04039165
Conditions
  1. Metabolic Syndrome
Interventions
  1. Behavioral: PP-MI Intervention
MeSH:Metabolic Syndrome Syndrome

Primary Outcomes

Description: Feasibility will be measured by examining the number of completed exercises.

Measure: Feasibility of the PP-MI-Based Health Behavior Intervention

Time: 8 weeks of group sessions

Secondary Outcomes

Description: Participants will rate the ease and usefulness of each weekly activity (0-10).

Measure: Acceptability of Intervention

Time: 8 weeks

Description: ActiGraph GT3X+ accelerometers are validated as measures of physical activity and have been used in numerous studies of physical activity in patients with medical illness. In this trial, participants will wear the accelerometer to assess the feasibility of doing so and to ensure adequate capture of physical activity.

Measure: Physical Activity Adherence (Actigraph)

Time: Baseline, weeks 9, 24 (baseline, weeks 9, 17, 33 for the WLC group)

Description: Feasibility will be measured by examining the rates of use of the Actigraph.

Measure: Feasibility of Actigraph

Time: Baseline, weeks 9, 24 (baseline, weeks 9, 17, 33 for the WLC group)

Description: The LOT-R is a well-validated 6-item instrument used to measure dispositional optimism. (Range: 5-30)

Measure: Changes in Life Orientation Test- Revised Scores

Time: Baseline, weeks 9, 24 (Baseline, weeks 17 and 33 for the WLC group)

Description: The positive affect items on the Positive and Negative Affect Schedule (PANAS), a well-validated scale used in other intervention trials, will be used to measure positive affect. (Range: 10-50)

Measure: Changes in Positive and Negative Affect Schedule Scores

Time: Baseline, weeks 9, 24 (Baseline, weeks 17 and 33 for the WLC group)

Description: The HADS will be used to measure depression and anxiety. This is a well-validated scale with few somatic symptom items that can confound mood/anxiety assessment in medically-ill patients. (Range: HADS-A, HADS-D; 0-21 each)

Measure: Changes in The Hospital Anxiety and Depression Scale Scores

Time: Baseline, weeks 9, 24 (Baseline, weeks 17 and 33 for the WLC group)

Description: The BBAQ is a 21-item measure, published by the US Centers for Disease Control and Prevention (CDC), that explores seven main categories of barriers, including lack of time, energy, and resources. (Range: 0-63)

Measure: Changes in Barriers to Being Active Quiz Scores

Time: Baseline, weeks 9, 24 (Baseline, weeks 17 and 33 for the WLC group)

Description: The SOM will be used to capture the changeable nature of optimism based on time and situation. (Range: 7-35)

Measure: Changes in State Optimism Measure

Time: Baseline, weeks 9, 24 (Baseline, weeks 17 and 33 for the WLC group)

Description: The SF-12 will be used to measure quality of life. This instrument has been used in many patient-oriented studies. (Range: SF-12 PCS and SF-12 MCS); range 0-100 each)

Measure: Changes in The Medical Outcomes Study Short Form-12 Scores

Time: Baseline, weeks 9, 24 (Baseline, weeks 17 and 33 for the WLC group)

Description: The IPAQ-SF is a validated scale that measures self-reported physical activity in the past 7 days in the domains of vigorous activity, moderate activity, and walking.

Measure: Changes in The International Physical Activity Questionnaire-Short Form Scores

Time: Pre-baseline screening, weeks 9, 24 (Pre-baseline, weeks 17 and 33 for the WLC group)

Description: The CDC's BRFSS Fruit and Vegetable Module is a brief questionnaire about frequency of eating different types of fruits and vegetables.

Measure: Changes in Behavioral Risk Factor Surveillance System Fruit and Vegetable Module

Time: Baseline, weeks 9, 24 (Baseline, weeks 17 and 33 for the WLC group)

Description: The National Cancer Institute's Percentage Energy from Fat Screen is a brief questionnaire that estimates people's typical percentage of energy derived from eating common fat-containing foods, as fat content is related to metabolic syndrome progression.

Measure: Changes in National Cancer Institute's Percentage Energy from Fat Screener Scores

Time: Baseline, weeks 9, 24 (Baseline, weeks 17 and 33 for the WLC group)
4 A Virtual Nutritional Education Delivered Through a Hospital Teaching Kitchen : a Proof-of-concept Study

A novel way of delivering nutritional education is through experiential learning in a teaching kitchen setting. Studies have shown that patients with metabolic syndrome who underwent a series of classes that featured nutrition recommendations and cooking classes had improved cardiac health. Boston Medical Center (BMC) serves many underserved, low-income patients and has developed an innovative strategy to combat food insecurity and its consequences. This includes a preventative food pantry, a teaching kitchen, and a rooftop farm that provides fresh produce directly to the patients. The presence of this well-established three-pronged approach places our institution in an ideal position to develop a nutritional education intervention that supports experiential learning in this high-risk population. Given the increasing focus on providing remote experiences to minimize contact and risk of infection with Sars-COV-2, the investigators are proposing a study where patients can benefit from nutritional education virtually. Patients with food insecurity and metabolic syndrome who utilize the food pantry will be invited to an educational program conducted on zoom. The program will be run by a registered dietician and chef who will deliver education virtually. Data will be collected using surveys, phone interviews, chart review, and home monitoring to test both the feasibility of running such an intervention virtually and to explore whether attending this program improves cardiac health in patients.

NCT04509206
Conditions
  1. Cardiac Health
  2. Metabolic Syndrome
Interventions
  1. Behavioral: Nutritional education
MeSH:Metabolic Syndrome

Primary Outcomes

Description: based on number of people invited to participate, number recruited and consented and number attended

Measure: recruitment rates

Time: 12 months

Description: based on attendance at each virtual educational session

Measure: retention rates

Time: 12 months

Description: information will be obtained through qualitative interviews

Measure: facilitators for nutritional education

Time: 12 months

Description: information will be obtained through qualitative interviews

Measure: barriers to nutritional education

Time: 12 months

Secondary Outcomes

Description: through qualitative interview

Measure: knowledge of healthy foods

Time: 12 months

Description: Baseline BP will be extracted from medical chart. Subjects will be provided with a home BP cuff. BP measurements performed by the patient will be recorded on the BP app. The 6 month follow BP will be extracted from the medical chart if available.

Measure: change in blood pressure (BP)

Time: baseline, up to 6 months

Description: Baseline blood glucose will be extracted from medical chart. Subjects will use their own glucometer to measuture their blood glucose. glucose measurements performed by the patient will be recorded on the glucometer. The 6 month follow blood glucose will be extracted from the medical chart if available.

Measure: change in blood glucose

Time: baseline, up to 6 months

Description: Baseline will be extracted from the chart and 6 month will be extracted from the chart if available

Measure: change in hemoglobin A1c

Time: baseline, 6 months

Description: Baseline weight will be extracted from medical chart. Subjects will be provided with a home scale. weight measurements performed by the patient will be recorded on the scale app. The 6 month follow weight will be extracted from the medical chart if available.

Measure: change in weight

Time: baseline, up to 6 months
5 Developing and Testing a Technology-Based Translation of the Diabetes Prevention Program for Adult Primary Care Patients At-Risk of Developing Type 2 Diabetes Mellitus

DPPFit is a Healthy Lifestyle Intervention designed to reformat the effective strategies of the Diabetes Prevention Program (NDPP) into a tool for use in a primary care setting. DPPFit is a 16-week technology-based intervention for diabetes prevention. In keeping with the National DPP educational sessions, the intervention weeks follow the order and presentation of the N-DPP 16 session topics. The goal is to develop a pragmatic translation of the DPP that is effective in the real-world setting of primary care clinic. The hope is that in doing so, those at risk of developing type II diabetes mellitus will have evidenced-based prevention methods at their disposal.

NCT04564586
Conditions
  1. PreDiabetes
  2. Metabolic Syndrome, Protection Against
Interventions
  1. Behavioral: DPPFit
MeSH:Metabolic Syndrome Prediabetic State Glucose Intolerance

Primary Outcomes

Description: Weight Loss by % of change and total weight change (kg)

Measure: Weight Loss

Time: 12 Months

Description: Physical activity days/week, change > 10% of PA, Kcal/week

Measure: Physical Activity

Time: 6 months

Description: Change in Sedentary Time, Mins/day

Measure: Inactivity

Time: 6 months

Secondary Outcomes

Description: MOS SF-20 / MOS Social Support Scale

Measure: Health Related Quality of Life

Time: 6 months

Description: Change in % of HbA1c at 1 year follow-up

Measure: Hemoglobin A1c

Time: 12 months
6 Adaptive Study for Efficacy and Safety of Metformin Glycinate for the Treatment of Patients With MS and DM2, Hospitalized With Severe Acute Respiratory Syndrome Secondary to SARS-CoV-2. Randomized, Double-Blind, Phase IIIb.

The purpose of this study is to evaluate the efficacy and safety of metformin glycinate at dose of 620 mg twice per day plus standard treatment comparing to standard treatment alone (we will use placebo) of patients who have metabolic syndrome or type 2 diabetes, which have severe acute respiratory syndrome secondary to SARS-CoV-2.

NCT04626089
Conditions
  1. Severe Acute Respiratory Syndrome Coronavirus 2
  2. Metabolic Syndrome
  3. Type 2 Diabetes
Interventions
  1. Drug: metformin glycinate
  2. Drug: Placebo oral tablet
MeSH:Coronavirus Infections Severe Acute Resp Severe Acute Respiratory Syndrome Diabetes Mellitus, Type 2 Metabolic Syndrome Syndrome
HPO:Type II diabetes mellitus

Primary Outcomes

Description: Assess differences in SARS-CoV-2 viral load between participants that receive placebo vs metformin glycinate

Measure: Viral Load

Time: Day 0 to Day 8 or patient discharge day

Secondary Outcomes

Description: Assess length of supplementary oxygen

Measure: Days of supplementary oxygen if apply

Time: Day 0 to day 28 or patient discharge day

Description: Assess length of mechanical ventilation

Measure: Days of supplementary mechanical ventilation if apply

Time: Day 0 to day 28 or patient discharge day

Description: Assess length of hospitalization

Measure: Days of Hospitalization

Time: Day 0 to day 28 or patients discharge day

Description: Assess the difference in the Proportion of participants with normalization of fever between participants that receive placebo vs the patients with metformin glycinate

Measure: Normalization of fever

Time: Day 0 to day 28 or patient discharge day

Description: Assess the difference in the Proportion of participants with normalization of oxygen saturation between participants that receive placebo vs the patients with metformin glycinate

Measure: Normalization of oxigen saturation

Time: Day 0 to day 28 or patient discharge day

Description: Assess the difference in the number of deaths between participants who received placebo versus the patients with metformin glycinate

Measure: Number of deaths

Time: Day 0 to day 28 or patient discharge day

Description: Evaluate if the level increase or decrease in serum creatinine compared to baseline. units: mg/dl

Measure: Change in Serum creatinine levels

Time: Day 0 to day 28 or patients discharge day

Description: Evaluate if the level increase or decrease in serum Creatine kinase-MB compared to baseline. Units: UI/l

Measure: Change in serum Troponin I

Time: Day 0 to day 28 or patients discharge day

Description: Evaluate if the level increase or decrease in serum aspartate aminotransferase compared to baseline. units: IU/l

Measure: Change in serum aspartate aminotransferase levels

Time: Day 0 to day 28 or patients discharge day

Description: Evaluate if the level increase or decrease in serum Creatine kinase-MB compared to baseline. Units: UI/l

Measure: Change in serum Creatine kinase-MB levels

Time: Day 0 to day 28 or patients discharge day

Description: Assess by incidence of grade 3, grade 4 and Serious adverse events

Measure: Incidence of adverse event

Time: Day 0 to day 28 or patients discharge day
7 Rush Coronavirus Disease Virtual Lifestyle Program to Boost Host Resistance in Patients With Elevated Cardiometabolic Risk: A Proof-of-Concept Study

This is a proof-of-concept study of a virtual version of a lifestyle intervention aimed at reducing cardiometabolic risk in patients with the Metabolic Syndrome (MetS). The aim is to recruit 12 patients at high risk for coronavirus infection based upon a diagnosis of obesity and the MetS, conduct a 12-week virtual version of the in-person intervention, and explore efficacy using clinically significant pre-specified targets for weight, diet, physical activity, stress, and markers of inflammation. In addition, the investigators will explore safety, fidelity, feasibility, and acceptability.

NCT04637477
Conditions
  1. Metabolic Syndrome
  2. Obesity
Interventions
  1. Behavioral: Virtual ELM
MeSH:Metabolic Syndrome Syndrome

Primary Outcomes

Description: Weight is recorded in kilograms to the nearest 0.1 kg using a flat scale.

Measure: Fifty percent of participants will lose >5% of baseline weight after completing the intervention at 3 months.

Time: 3 months after baseline assessment

Secondary Outcomes

Description: The proportion of participants who are in remission of the metabolic syndrome (MetS) at 3 months will be calculated. MetS is defined by the Joint Interim Statement of the IDF, NHLBI, AHA, WHF, IAS, IASO as having 3 or more risk factors for cardiovascular disease. To be considered in remission of MetS the participant must have less than 3 of the following 5 criteria: 1) Waist circumference based on AHA/NHLBI (ATP III) cut points of ≥ 102 cm for men and ≥ 88 cm for women; 2) Fasting triglycerides ≥150 mg/dL or treatment for elevated triglycerides; 3) Fasting HDL cholesterol <40 mg/dL in men or <50 mg/dL in women, or treatment for low HDL; 4) Systolic blood pressure ≥130 m Hg, diastolic blood pressure ≥85 mm Hg, or treatment for hypertension; and 5) Fasting plasma glucose 100-125 mg/dL.

Measure: Remission of components of metabolic syndrome

Time: Measured at 3 months from baseline

Description: The proportion of participants who eat 2 cups of vegetables per day. This will be assessed using the National Cancer Institute (NCI) Fruit and Vegetable Intake Screener from the Eating at America's Table Study: All Day Screener.

Measure: Vegetable consumption

Time: Measured at 3 months from baseline

Description: The proportion of participants who achieve 150 minutes of at least moderate intensity physical activity per week will be calculated. Activity is measured using an accelerometer (Actigraph wGT3X-BT) worn on the right hip for 7 days and for at least 10 hours/day.

Measure: Physical activity

Time: Measured at 3 months from baseline

Description: Participants will complete the Five Facet Mindfulness Questionnaire. A subscale comprised of 3-facets (observe, act with awareness, and nonreact) will be utilized to measure mindfulness in ELM. The proportion of participants who improve in a 3-facet mindfulness score of greater than or equal to 1 standard deviation of baseline distribution will be calculated. The scale range for the 5-facet mindfulness questionnaire is 39-195 with a lower score reflecting less mindfulness. The 3-facet scale range is 23-115 with a lower score reflecting less mindfulness.

Measure: Facets of Mindfulness

Time: Measuring change from baseline mindfulness at 3 months

Description: The proportion of participants who improve in habit strength in 4 domains (diet, physical activity, emotional control, and sensory awareness), defined as a mean of ≥ 4 on the Self-Report Habit Index will be calculated. A 5-point Likert scale will be used with a scale range from 0 to 20. A lower score reflects a weaker habit.

Measure: Habit formation

Time: Measured at 3 months after baseline

Other Outcomes

Description: MetS components will be assessed as a continuous sex- and race/ethnicity-specific score. The higher the MetS Severity score, the higher risk/severity. (Gurka MJ, Lilly CL, Oliver MN, DeBoer MD. An examination of sex and racial/ethnic differences in the metabolic syndrome among adults: a confirmatory factor analysis and a resulting continuous severity score. Metabolism. 2014;63:218-25).

Measure: Metabolic syndrome severity score

Time: Measured at 3 months after baseline

Description: Calculate the average weight loss (kg). Weight is recorded in kilograms to the nearest 0.1 kg using a flat scale.

Measure: Weight loss

Time: Measuring change from baseline to 3 months

Description: The percent of participants with the blood pressure component of the Metabolic Syndrome as defined by the Joint Interim Statement of the IDF, NHLBI, AHA, WHF, IAS, IASO. The criteria for blood pressure is met when systolic blood pressure ≥130 m Hg, diastolic blood pressure ≥85 mm Hg, or self-reported treatment for hypertension. Average of 3 seated resting blood pressure measurements using NHANES protocol and cuff sizes based on arm circumference. Device is OMRON HEM-907XL Cuff sizes: Small (17.0-22.0 cm) Medium/Adult (22.1-32.0 cm) Large (32.1-42.0 cm) Extra Large (42.0-50.0 cm)

Measure: Blood pressure (metabolic syndrome component)

Time: Measured at baseline and 3 months

Description: Percent of participants with the waist circumference component of the Metabolic Syndrome as defined by the Joint Interim Statement of the IDF, NHLBI, AHA, WHF, IAS, IASO. The criteria is based on AHA/NHLBI (ATP III) cut points of ≥ 102 cm for men and ≥ 88 cm for women. Waist circumference will be measured using a tape measure, following the National Heart, Lung, and Blood Institute waist circumference assessment guidelines.

Measure: Waist circumference (metabolic syndrome component)

Time: Measured at baseline and 3 months

Description: The percent of participants with the triglyceride component of the Metabolic Syndrome as defined by the Joint Interim Statement of the IDF, NHLBI, AHA, WHF, IAS, IASO. The criteria for elevated triglyceride levels are fasting triglycerides ≥150 mg/dL or treatment for elevated triglycerides. A fasting blood sample will be sent to Quest diagnostics for analysis.

Measure: Triglycerides (metabolic syndrome component)

Time: Measured at baseline and 3 months

Description: The percent of participants with the HDL cholesterol component of the Metabolic Syndrome as defined by the Joint Interim Statement of the IDF, NHLBI, AHA, WHF, IAS, IASO. The criteria for low HDL are fasting HDL cholesterol <40 mg/dL in men or <50 mg/dL in women, or treatment for low HDL. A fasting blood sample will be sent to Quest diagnostics for analysis.

Measure: High-Density Lipoproteins (HDL) cholesterol (metabolic syndrome component)

Time: Measured at baseline and 3 months

Description: The percent of participants with the fasting glucose component of the Metabolic Syndrome as defined by the Joint Interim Statement of the IDF, NHLBI, AHA, WHF, IAS, IASO. Fasting plasma glucose 100-125 mg/dL (range inclusive) is considered a component of the metabolic syndrome. A fasting blood sample will be sent to Quest diagnostics for analysis.

Measure: Fasting plasma glucose (metabolic syndrome component)

Time: Measured at baseline and 3 months

Description: The percent of participants who lowered their Body Mass Index (BMI). Height will be recorded in cm to nearest 0.25 cm and weight recorded in kg to nearest 0.1 kg. BMI = weight (kg) / height squared (m). The weight and height will be combined to report BMI in kg/m^2.

Measure: Body mass index

Time: Measuring change from baseline to 3 months

Description: The frequency of contacts within participants' health network.

Measure: Frequency of contacts within health network

Time: Measuring change from baseline to 3 months

Description: Percent of participants who improved in the energy and vitality subscale from the Medical Outcomes Study 36-item Short-Form Health Survey (SF-36) version 1. The scale range is 0 to 100 with a low score reflecting a lower energy and vitality.

Measure: Energy and vitality index

Time: Measuring change from baseline to 3 months

Description: Measuring change of perceived stress score from baseline using the 10-item Perceived Stress Scale. The scale range is from 0 to 40. A lower score reflects lower levels of stress.

Measure: Perceived stress

Time: Measuring change from baseline to 3 months

Description: Measuring change of depressive symptoms from baseline using the 8-item self-report Patient Health Questionnaire Depression Scale (PHQ-8). This scale ranges from 0 to 24 with a lower score reflecting less (or no) depressive symptoms.

Measure: Depressive symptoms

Time: Measuring change from baseline to 3 months

Description: Measuring change in Hemoglobin A1c levels. A blood assay will be analyzed by Quest Diagnostics. Standard safety procedures are used in performing the participant blood draw required for this measure.

Measure: Hemoglobin A1c levels

Time: Measuring change from baseline to 3 months

Description: Measuring change in frequency of consumption of sugar-sweetened beverages using the Behavioral Risk Factor Surveillance System - Beverage Items.

Measure: Sugar-sweetened beverages

Time: Measuring change from baseline to 3 months

Description: Measuring change on eating competence using the 16-item Eating Competence Survey. The scale ranges from 0 to 48 with a higher score reflecting a better outcome.

Measure: Eating competence

Time: Measuring change from baseline to 3 months

Description: Measuring decrease inflammation by using the benchmark of 20% improvement in hs-CRP.

Measure: C-reactive protein (hs-CRP)

Time: Measuring change from baseline to 3 months

Description: Measuring decrease inflammation by using the benchmark of 20% improvement in IL-6.

Measure: Interleukin 6 (IL-6)

Time: Measuring change from baseline to 3 months

Description: Explore the fidelity of treatment delivery, receipt, and enactment. Treatment delivery is measured by the investigator reviewing the session recordings and completing a standardized form assessing the interventionists' ability to deliver the program as designed. Receipt of treatment is assessed by attendance. Enactment of treatment is self-reported by participants in a 4-item questionnaire after each session.

Measure: Fidelity of intervention

Time: Measuring during 3-month lifestyle program

Description: Explore feasibility of recruitment by reviewing the screened to enrollment ratio. Research staff will also take qualitative notes on the process to inform future recruitment strategies.

Measure: Feasibility of recruitment

Time: Up to 12 weeks

HPO Nodes


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


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Reports

Data processed on December 13, 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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