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Report for Clinical Trial NCT03525002

Developed by Shray Alag, 2020.
SNP Clinical Trial Gene

Dopamine Action on Metabolism Depending on Genetic Heterogeneity - a Randomized, Placebo-controlled Double Blind Study

Obesity is a widespread disease with increasing prevalence and associated with serious secondary complications. So far, the origin of the disease, regardless of an existing positive energy balance, is not fully understood. In addition to environmental factors, the genetic background plays an important role in the pathogenesis of obesity. Of common genetic polymorphisms, variants in the fat mass and obesity associated gene (FTO) locus have the highest effect size on body weight. Animal and first clinical studies indicate that FTO variants interact with dopamine signaling in the brain, thus influencing the risk of overweight. In fact, preliminary results indicate that enhancing dopamine signaling with the dopamine agonist bromocriptine, depending on the FTO genotype, either induces weight loss or has a neutral effect on body weight. The planned clinical trial serves to develop a genotype-specific and thus individualized therapy approach for obesity. The influence of dopamine agonist therapy on weight loss as a function of the FTO (rs8050136) genotype is to be tested. Here, the greatest weight loss is expected to occur in subjects carrying the homozygous risk-allele (AA). So far, there are only a few established conservative therapy forms of obesity, so that bariatric interventions with an increasing rate are necessary to achieve weight loss and thus a reduction in overall morbidity and mortality. Among the approved drug therapies for obesity, bromocriptine is commonly used. In addition, some interventions require injections. An early, conservative individualized, genotype-specific treatment with little side-effects would enable simple treatment of obesity. Study design: 150 obese (BMI > 30) subjects (50 / study center) will be enrolled in the study. The subjects will be stratified according to their FTO genotype (rs8050136). Subjects will be randomized into placebo or bromocriptine treatment group. Treatment will last for 18 weeks and a follow-up will be performed 30 weeks after baseline.

NCT03525002 Obesity

2 Interventions

Name: Bromocriptine

Description: In each FTO genotype group participants will be randomly receive bromocriptine or placebo.

Type: Drug

FTO SNP rs8050136 (AA), Bromocriptine FTO SNP rs8050136 (CA), Bromocriptine FTO SNP rs8050136 (CC), Bromocriptine

Name: Placebo

Description: In each FTO genotype group participants will be randomly receive bromocriptine or placebo.

Type: Other

FTO SNP rs8050136 (AA), Placebo FTO SNP rs8050136 (CA), Placebo FTO SNP rs8050136 (CC), Placebo


Primary Outcomes

Description: Interaction between FTO (single nucleotide peptide) SNP rs8050136 genotype and treatment (bromocriptine or placebo) on change in body weight.

Measure: Interaction between FTO genotype and treatment on change in body weight.

Time: 18 weeks

Secondary Outcomes

Measure: Effect of bromocriptine vs. placebo on body weight

Time: 18 weeks

Description: Dietary intake will be monitored by food diaries

Measure: Effect of bromocriptine vs. placebo on dietary intake

Time: 18 weeks

Description: Processing of food cues in the brain will be assessed by functional magnetic resonance imaging before and after treatment with bromocriptine or placebo

Measure: Effect of bromocriptine vs. placebo on processing of food cues in the brain

Time: 18 weeks

Description: Body fat distribution will be assessed by magnetic resonance imaging and magnetic resonance spectroscopy before and after treatment with bromocriptine or placebo

Measure: Effect of bromocriptine vs. placebo on body fat distribution

Time: 18 weeks

Description: Whole body insulin sensitivity will be quantified from 5 point 75g oral glucose tolerance test before and after treatment with bromocriptine or placebo

Measure: Effect of bromocriptine vs. placebo on whole body insulin sensitivity

Time: 18 weeks

Description: Insulin secretion will be quantified from 5 point 75g oral glucose tolerance test before and after treatment with bromocriptine or placebo

Measure: Effect of bromocriptine vs. placebo on insulin secretion

Time: 18 weeks

Description: Glucose tolerance will be assessed by 75g oral glucose tolerance test before and after treatment with bromocriptine or placebo

Measure: Effect of bromocriptine vs. placebo on glucose tolerance

Time: 18 weeks

Description: Brain insulin sensitivity will be assessed by functional magnetic resonance imaging combined with intranasal insulin administration before and after treatment with bromocriptine or placebo

Measure: Effect of bromocriptine vs. placebo on brain insulin sensitivity

Time: 18 weeks

Description: Resting energy expenditure will be assessed by indirect calorimetry before and after treatment with bromocriptine or placebo

Measure: Effect of bromocriptine vs. placebo on resting energy expenditure

Time: 18 weeks

Description: Physical activity will be monitored using an accelerometer

Measure: Effect of bromocriptine vs. placebo on physical activity

Time: 18 weeks

Measure: Effect of bromocriptine vs. placebo on serum prolactin concentrations

Time: 18 weeks

Purpose: Treatment

Allocation: Randomized

Parallel Assignment


There is one SNP

SNPs


1 rs8050136

The influence of dopamine agonist therapy on weight loss as a function of the FTO (rs8050136) genotype is to be tested.

The subjects will be stratified according to their FTO genotype (rs8050136).

Interaction between FTO genotype and treatment on change in body weight.. Interaction between FTO (single nucleotide peptide) SNP rs8050136 genotype and treatment (bromocriptine or placebo) on change in body weight.. Effect of bromocriptine vs. placebo on body weight.



HPO Nodes