Ignite Creation Date:
2024-05-06 @ 11:28 AM
Last Modification Date:
2024-10-26 @ 12:45 PM
Study NCT ID:
NCT03525002
Status:
RECRUITING
Last Update Posted:
2024-02-02
First Post:
2018-05-02
Brief Title:
Dopamine Action on Metabolism in Relation to Genotype
Sponsor:
University Hospital Tuebingen
Organization:
University Hospital Tuebingen
Study Overview
Official Title:
Dopamine Action on Metabolism Depending on Genetic Heterogeneity - a Randomized Placebo-controlled Double Blind Study
Status:
RECRUITING
Status Verified Date:
2024-02
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
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
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
Detailed Description:
None
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None