There are 11 clinical trials

Clinical Trials

1 The Role of FTO Gene Polymorphism and Insulin Preparation in Overweight/Obesity in Children With Type 1 Diabetes Mellitus

The project aims at assessment of the effect of the FTO gene polymorphism and the type of treatment on the development of overweight/obesity and features of metabolic syndrome in children with type 1 diabetes. Gene polymorphism including some genetic variants may predispose to the development of cardiovascular diseases and their complications. The A allele of the FTO gene predisposing to obesity occurs in approximately 40% of the European population and each copy of this allele can increase BMI by 0.1 Z-score i.e. by 0.4 kg/m2. Insulin therapy in diabetic patients may result in excess body weight gain. Therefore we need studies involving large groups of children and assessing cardiovascular risk factors in type 1 diabetes along with their genetic associations. Patients: The study will include 1500 children with type 1 diabetes, aged 6-18 years. Reference group will be made of 1500 children in whom type 1 diabetes was excluded. The following variables will be assessed in the treatment group: 1) Anthropometric data and questionnaire data: age, sex, body height and weight, body mass index (BMI), waist and hip circumferences, arm and thigh circumferences, family history of overweight/obesity, type 1 or 2 diabetes or cardiovascular disease, 2) Primary disease characteristics: age of the disease onset, treatment regimen, mean daily insulin consumption per kg body weight, brands of insulin products, glycated haemoglobin, BMI from the first 3-6 months following diabetes onset, diet, conversion of these data into actual and ideal calorie intake 3) Laboratory data - lipid profile and blood pressure (average of three measurements). Methodology: Gene polymorphism analysis in the extracted DNA will be made with the real-time PCR method using TaqMan 7900 HT by Applied Biosystems. Correlations between the FTO gene polymorphism and clinical variables such as BMI (including BMI increase since the disease onset), body weight and height, waist and hip circumferences, arm and thigh circumferences, and blood pressure will be assessed by a professional statistician with a specially dedicated software. Moreover parameters such as diet and metabolic control will be assessed. As regards insulin therapy the following variables will be analysed: insulin injection device, therapy regimen (intensive versus functional; brands and types of insulin products: human insulin versus insulin analogue), consumption of insulin. All of the above listed variables will be correlated with the genotypes found in the gene polymorphism analysis. The study has been approved by Bioethics Committee of the Medical University in Białystok. Results: The authors of the project expect that the effect of the FTO gene polymorphism on overweight/obesity and features of metabolic syndrome in children with type 1 diabetes will be shown. Moreover the project will enable assessment of the effect of the therapeutic regimen, including the type of insulin product, on body weight increase in the course of type 1 diabetes treatment in the context of the FTO gene polymorphism. Confirmation of the above associations and identification of a group at risk of excess body weight increase in the course of insulin therapy may help physicians, parents and patients to avoid this complication. Therefore clinical benefit of this project will include identification - based on the genetic assays results - of a group of type 1 diabetic children particularly likely to develop overweight, obesity and other cardiovascular risk factors.

NCT01279161 Type 1 Diabetes Mellitus

MeSH:Diabetes Mellitus Obesity Diabetes Mellitus, Type 1 Pediatric Obesity

HPO:Diabetes mellitus Obesity Type I diabetes mellitus

Particular objective of the project is providing an answer to the question: Are type 1 diabetic children who are carriers of the AA genotype of the FTO gene polymorphism (rs9939609) at risk of more weight gain in the course of insulin therapy when compared to carriers of the TA and TT genotypes of this polymorphism ?

2 Polymorphisms in Genes Encoding the Estrogen Metabolism Enzymes and Effects of Hormone Therapy for Oral Low Dose or Not Oral on Variables Related Endothelial Function, Inflammation and Metabolic Profile in Patients in Recent Menopause Study Pharmacogenetic

This is cross-over, randomized clinical trial, with objective to evaluate the effects of low-dose oral hormone therapy and non-oral hormone therapy on endothelial function markers (fibrinogen, von Willebrand factor, c-reactive protein), natriuretic peptide and on anthropometric, metabolic and hormonal variables in early and healthy postmenopausal women and analyzing polymorphisms in the estrogen receptor gene and FTO polymorphisms Patients will be randomized to receive oral hormone treatment or non-oral hormone treatment The investigators hypothesis is that a different genotypes in the receptor estrogen gene and FTO may have an influences on treatment response in metabolic markers and cardiovascular risk

NCT01432028 Postmenopause Drug: Estradiol and Progesterone Drug: Estradiol and Drospirenone

Influence of 2 polymorphisms (rs9939609 and rs8050136) on the effect of different treatment regimens.

3 Obesity in Schoolchildren of Basic Education: a Study of Interdisciplinary Intervention - Phase III

The study aims to evaluate the possible effects of an exercise program, nutritional and psychological, postural orientation and guidance of oral health on body composition, physical activity levels and lifestyle, physical fitness and health and motor performance, the factors risk of cardiovascular disease, eating habits, the cognition levels, the psychological profile, the body posture of children and adolescents with overweight and obesity, considering the presence of risk genotype associated with the development of obesity. In addition, identify the effects of orientation for oral health on the quality of life and healthy oral habits.

NCT02769897 Obesity Adolescent Behavior Behavioral: Physical exercise

MeSH:Obesity

HPO:Obesity

The following parameters will be evaluated: anthropometric (BMI, waist circumference and skinfold thickness); hematologic and biochemical analysis (HDL cholesterol, LDL cholesterol, total cholesterol, triglycerides, glucose, insulin, adiponectin, leptin, resistin, C reative protein, ALT, AST, glycated hemoglobin, IL-6, IL-10, TNF-α, cortisol, irisina, F2 isoprostane and uric acid); polymorphism related to obesity (FTO rs9939609); related-health physical fitness (flexibility; sit and reach test; abdominal strength and cardiorespiratory fitness); postural deviations evaluated by the photogrammetry method - SAPO program.

4 FTO rs9939609 and PPARy rs1801282 Polymorphisms in Mexican Adolescents With Overweight and Obesity at High Risk for Developing Diabetes

Background and Aims: The presence of the FTO rs9939609 and PPARy rs1801282 polymorphisms suggests changes in energy metabolism; this variation may be responsible for the development of various diseases including obesity. The aim of this study was to identify the presence of these polymorphisms in Mexican adolescents with overweight and obesity at high risk for developing diabetes. Methods and Results: This was a descriptive cross-sectional study, where 71 healthy adolescents (average age of 16) were included. Anthropometric measurements, Body mass index, as well as the determination of glucose, insulin and HOMA index were calculated from all the patients. The FTO rs9939609 and PPARy rs1801282 polymorphisms were determined by real-time PCR.

NCT02886013 Metabolic Syndrome Insulin Resistance

MeSH:Metabolic Syndrome Insulin Resistance

HPO:Insulin resistance

FTO rs9939609 and PPARy rs1801282 Polymorphisms in Mexican Adolescents With Overweight and Obesity at High Risk for Developing Diabetes.

FTO rs9939609 and PPARy rs1801282 Polymorphisms in Mexican Adolescents Background and Aims: The presence of the FTO rs9939609 and PPARy rs1801282 polymorphisms suggests changes in energy metabolism; this variation may be responsible for the development of various diseases including obesity.

The FTO rs9939609 and PPARy rs1801282 polymorphisms were determined by real-time PCR.

Prevalence of the FTO rs9939609 and PPARy rs1801282 polymorphisms..

5 Comparison of the Effect of MediterrAsian Diet With Two Different Calorie Restriction on Anthropometric Indices in Carriers of FTO rs9939609 Polymorphism With Overweigh: Toward Personalized Nutrition

Background: Obesity treatment should be individualized since some calorie restricted diet doesn't work for some individuals. Objective: we assess the effect of two different calorie restriction with MediterrAsian diet on weight loss of FTO rs9939609 carriers with overweight. Methods: we recruit 80 healthy overweight participants aged 20-45 years that randomly allocated in two interventional group [group 1: Mediterrasian diet according to adjusted ideal body weight with 500 calories restriction (RD) and group 2: without 500 calories restriction (NRD)+ Moderate physical activity]. Anthropometric indices will be assesses for all participants weekly for two month. The criteria for weight loss is 250-500 grams weekly. Metabolic indices, physical activity and psychologic aspects will be assesses at baseline and the end of the intervention. Dietary adherence will be checked by 24hr recalls at day 0, 30 and 60. At the end of the study, we compare carriers with different alleles (AA+TA and TT) in two intervention groups to find out which calorie restriction is appropriate for each genotype. Significant p-value is less than 0.05.

NCT02940197 Obesity Dietary Modification Behavioral: MediterrAsian diet

MeSH:Overweight

Comparison of the Effect of MediterrAsian Diet With Two Different Calorie Restriction on Anthropometric Indices in Carriers of FTO rs9939609 Polymorphism With Overweigh: Toward Personalized Nutrition.

Comparison of Two Calorie Restricted MediterrAsian Diet on Weight Loss in FTO rs9939609 Overweight Carriers Background: Obesity treatment should be individualized since some calorie restricted diet doesn't work for some individuals.

Objective: we assess the effect of two different calorie restriction with MediterrAsian diet on weight loss of FTO rs9939609 carriers with overweight.

6 Using Personalized Nutrigenomics Testing to Mitigate Overweight/Obesity Risk in Two Distinct Patient Populations: A Multicentre Randomized Clinical Intervention Trial

The investigators hypothesize that compared to the provision of population-based lifestyle advice, providing DNA-based lifestyle advice via personalized nutrigenomics testing (PNT) to two distinct patient populations (Family Health Team patients receiving a lifestyle counselling intervention and transplant recipients) will lead to greater reductions in percent body fat. In addition, it will motivate them to adopt healthier dietary and physical activity habits through changes in attitudes and/or subjective norms and/or behavioural control, lead to greater fat loss (kg), increased percent lean mass and therefore improve health and quality of life outcomes for both patient populations. In addition, it is hypothesized that dietary strategies related to the intake of one or more dietary components of interest will mitigate post-transplant weight gain associated with three SNPs of interest. This is a randomized clinical intervention trial involving a total of four groups of patients (n = 400). The two main patient groups include overweight or obese, stable transplant recipients and overweight or obese patients who are attending group counselling sessions at the East Elgin Family Health Team. Within these two main groups, there will be two sub-groups. Patients will be randomized to receive either PNT or standard nutrition intervention (SNI). Baseline data will be conducted consisting of a food frequency questionnaire and three-day food records using a validated multiple pass method. Bioelectrical Impedance Analysis (BIA) will be conducted to assess body composition and to derive percent body fat and lean mass. Weight and height will be measured using a weigh scale and stadiometer. Attitudes, subjective norms and behavioural control will be assessed using a Theory of Planned Behaviour Questionnaire. Those patients randomized to the PNT group will be instructed on a tailored nutrition care plan and physical activity recommendations based on their individual genetic profile. At the same time, the SNI group will be instructed on general nutrition and physical activity recommendations for weight loss, which include the use of dietary strategies from the standard tool ('Just the Basics') used by registered dietitians for transplant patients and the GLB program for patients attending the East Elgin Family Health Team sessions. Monthly email reminders or phone calls (depending on patient preference) will be sent to transplant recipients as a reminder of their nutrition and physical activity plan. Reminders of nutrition and physical activity goals for the Family Health Team participants are incorporated into the GLB program. Three months, six months and twelve months after baseline data collection and individual nutrition interventions, baseline data will be repeated. After the study is complete, participants in the SNI group will be offered a nutrigenomics report and consultation with a registered dietitian. A paired t-test or repeated measures ANOVA will be used to assess within group change from baseline to each follow-up time point for: BMI, body fat, lean mass, and dietary intake. A repeated measures ANOVA will be used to test between group differences from baseline to each follow-up time point for: BMI, body fat, lean mass, and dietary intake. If significant mean differences are detected, a Tukey's post hoc test will be used to compare differences by group. Statistical significance will be determined by P < 0.05. General linear regression models will be used to assess interactions between each genotype of interest and each dietary component of interest on BMI and body composition from baseline to each follow-up time point.

NCT03015012 Transplant-Related Disorder Overweight and Obesity Genetic: Personalized Nutrigenomics Testing (PNT) Other: Standard Nutrition Intervention (SNI)

MeSH:Obesity Overweight

HPO:Obesity

Nutrigenomics (nutrition-genetic) interactions between ACE gene variants at rs4343, FTO gene variants at rs1558902 (in strong linkage disequilibrium with rs9939609) and MC4R (rs571312) to mitigate risk of post-transplant weight gain will be assessed for transplant recipients in the PNT group.. Inclusion Criteria: - TRANSPLANT PATIENTS: Adults greater than or equal to age 18, non-pregnant, non-lactating, attending Canadian Transplant Association meetings, BMI ≥ 25kg/m2, ≥1 year stable (not being treated for transplant rejection or infection) post-transplant, having access to a computer with email or a telephone at least one day per week and English speaking.

7 Effect of Exercise on Appetite, Energy Intake, Butyrylcholinesterase Activity and Gut Peptides in Men With Variants of the Obesity-linked FTO rs9939609 Polymorphism

Using a database of individuals with FTO genetic data, the study aims to assess the appetite, energy intake, butyrylcholinesterase, gut hormone responses to a bout of moderate- to high intensity exercise in individuals with genetic variations in the FTO gene.

NCT03025347 Appetitive Behavior Other: Control Other: Exercise

Effect of Exercise on Appetite, Energy Intake, Butyrylcholinesterase Activity and Gut Peptides in Men With Variants of the Obesity-linked FTO rs9939609 Polymorphism.

Inclusion Criteria: - non-smoker, not currently dieting, weight stable for >3 months (self-reported), no personal history of cardiovascular disease, metabolic disease or dyslipidaemia, European ancestry, no psychiatric or medical condition Exclusion Criteria: - food allergies, dislike or intolerance of study foods and drinks, irregular eating patterns, use of medication that could influence hormone concentrations Inclusion Criteria: - non-smoker, not currently dieting, weight stable for >3 months (self-reported), no personal history of cardiovascular disease, metabolic disease or dyslipidaemia, European ancestry, no psychiatric or medical condition Exclusion Criteria: - food allergies, dislike or intolerance of study foods and drinks, irregular eating patterns, use of medication that could influence hormone concentrations Appetitive Behavior The fat mass and obesity-associated gene (FTO) rs9939609 A allele is related to obesity, greater food intake and impaired postprandial reduction of ghrelin.

Exercise acutely suppresses levels of ghrelin and appetite, yet whether the response differs in people with or without the rs9939609 A allele is unknown.

This study assessed the effect of exercise on appetite, appetite-regulatory hormones and energy intake in variants of the FTO rs9939609 polymorphism.

Cohort The investigators initially recruited 202 subjects to a database and measured FTO rs9939609 genotype.

From these subjects, 12 individuals homozygous for the 'obesity-risk' rs9939609 A allele and 12 homozygous for the T allele were recruited.

8 Influence of Polymorphysms in the Fto and Ppar Gen Genes, Systemic Inflammation and Oxidative Stress in the Magnitude of Weight Loss Induced by Intermittent or Moderate Continuous High Intensity Training Programs

The study focuses on the influence of polymorphism in the FTO genes rs9939609 and PPARᵧ Pro12Ala, oxidative stress and systemic inflammation on changes in body composition and rest metabolism induced by HIIT and continuous aerobic programs in obese or overweight individuals.

NCT03568773 Overweight and Obesity Chronic Disease Other: High-intensity interval training Other: Aerobic exercise moderate intensity Other: Control Group

MeSH:Overweight Weight Loss Chronic Disease

HPO:Decreased body weight Weight loss

Influence of Genetic and Physiological in Weight Loss The study focuses on the influence of polymorphism in the FTO genes rs9939609 and PPARᵧ Pro12Ala, oxidative stress and systemic inflammation on changes in body composition and rest metabolism induced by HIIT and continuous aerobic programs in obese or overweight individuals.

Thus, the objective of the study is to analyze the influence of polymorphism in the genes FTO rs9939609 and PPARᵧ Pro12Ala, oxidative stress and systemic inflammation on changes in body composition and rest metabolism induced by continuous and continuous aerobic programs.

9 A Replicated Crossover Study to Explore Individual Variability of Appetite Responses to a Standardised Meal and Any Moderating Influence of the FTO Gene

The aim of this study is to examine the interindividual variability of subjective and hormonal appetite responses to a standardised meal in healthy men and explore any moderating influence of the fat mass and obesity associated gene (FTO). Participants homozygous for the obesity risk A allele (AA) or low risk T allele (TT) of FTO rs9939609 will complete two fasted control and two standardised meal (5025 kJ energy, 47% carbohydrate, 9% protein, 44% fat) conditions in randomised sequences. Ratings of perceived appetite and venous blood samples will be taken before and after the interventions. Interindividual differences in appetite responses and the potential moderating influence of the FTO gene will be examined using bivariate correlations and linear mixed modelling.

NCT03771690 Appetitive Behavior Obesity Genetic Predisposition to Disease Behavioral: Standardised meal

MeSH:Disease Susceptibility Genetic Predisposition to Disease

Participants homozygous for the obesity risk A allele (AA) or low risk T allele (TT) of FTO rs9939609 will complete two fasted control and two standardised meal (5025 kJ energy, 47% carbohydrate, 9% protein, 44% fat) conditions in randomised sequences.

Inclusion Criteria: - Homozygous minor allele (AA) or major allele (TT) FTO rs9939609 genotype; - Non-smoker; - Weight stable for the previous 3 months.

Exclusion Criteria: - Heterozygous FTO rs9939609 genotype (i.e., AT); - Any medical conditions (e.g., diabetes, coagulation or bleeding disorders); - Taking any medication that might influence appetite, fat metabolism or blood glucose; - Dieting or restrained eating behaviours; - Any food allergies.

A total of 18 healthy men will be recruited according to their FTO rs9939609 genotype: 9 homozygous minor allele (AA) and 9 homozygous major allele (TT).

10 Effects of Exercise Intervention and Confounding Factors on Type II Diabetic Muscles

The aim of the first year of this three-year plan is to analyze and compare the muscle quality of lower limb muscle (microcirculation, muscle performance and mechanical characteristics) and maximal aerobic exercise capacity in treadmill exercise tests for diabetic and non-diabetic cases. The hypotheses are:1) the muscle quality of lower limb muscle and maximal aerobic exercise capacity are different between participate with diabetic and non-diabetic, 2) the effect of the three-month aerobic exercise intervention or home exercise on the characteristics of the muscle quality are different , and 3) intrinsic factors (such as age, BMI, and HDL) and characteristics of specific FTO genes are influenced the training outcomes.

NCT03869411 Diabetes and Healthy Control FTO Gene Expression Aerobic Exercise Intervention or Home Exercise Pre-training and Post-training Behavioral: supervised aerobic exercise or home-based aerobic exercise

rs9939609 SNP analysis, record as TT or TA or AA type.

11 Impact of FTO Gene Variants and Lifestyle Factors on Obesity Traits in a Turkish Population

Studies have shown that the effect of fat mass and obesity-associated (FTO) gene on obesity is modulated by lifestyle factors. Hence, we aimed to determine whether two single nucleotide polymorphisms (SNPs) in the FTO gene are associated with obesity and to assess whether these associations were modified by lifestyle factors. The study included 200 obese and 200 non-obese individuals from Turkey. Our study suggests that the effect of the SNPs on obesity traits is likely to be influenced by lifestyle factors in this Turkish population.

NCT04205318 Obesity Diet Habit Genetic Predisposition

MeSH:Obesity Disease Susceptibility Genetic Predisposition to Disease

HPO:Obesity

FTO SNPs rs9939609 and rs10163409.

HPO Nodes