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

Who is this study for? Patients with obesity
What treatments are being studied? Bromocriptine
Status: Recruiting
Location: See all (3) locations...
Intervention Type: Drug, Other
Study Type: Interventional
Study Phase: Phase 2
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.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Maximum Age: 70
Healthy Volunteers: f
View:

• Body mass index (BMI) between \>30 kg/m².

• Understand and voluntarily sign an informed consent document prior to any study related assessments/procedures.

• Females of childbearing potential (FCBP) must agree to utilize a reliable form of contraception simultaneously or practice complete abstinence from heterosexual contact while participating in the study.

• Males must agree to use a latex condom during any heterosexual contact while participating in the study and to refrain from donating semen or sperm while participating in this study.

Locations
Other Locations
Germany
University Hospital Cologne
RECRUITING
Cologne
University Hospital Luebeck
RECRUITING
Lübeck
University of Tuebingen, Department of Internal Medicine IV
RECRUITING
Tübingen
Contact Information
Primary
Andreas Fritsche, Prof. Dr.
andreas.fritsche@med.uni-tuebingen.de
+49 7071-29 82714
Backup
Reiner Jumpertz-von Schwartzenberg
reiner.jumpertz-vs@med.uni-tuebingen.de
07071 29-68934
Time Frame
Start Date: 2018-05-03
Estimated Completion Date: 2025-06
Participants
Target number of participants: 150
Treatments
Placebo_comparator: FTO SNP rs8050136 (AA), Placebo
Participants with FTO SNP rs8050136 AA receiving matching Placebo
Active_comparator: FTO SNP rs8050136 (AA), Bromocriptine
Participants with FTO SNP rs8050136 AAreceiving Bromocriptine up to 5 mg
Placebo_comparator: FTO SNP rs8050136 (CA), Placebo
Participants with FTO SNP rs8050136 CA receiving matching Placebo
Active_comparator: FTO SNP rs8050136 (CA), Bromocriptine
Participants with FTO SNP rs8050136 CA receiving Bromocriptine up to 5 mg
Placebo_comparator: FTO SNP rs8050136 (CC), Placebo
Participants with FTO SNP rs8050136 CC receiving matching Placebo
Active_comparator: FTO SNP rs8050136 (CC), Bromocriptine
Participants with FTO SNP rs8050136 CC receiving Bromocriptine up to 5 mg
Related Therapeutic Areas
Sponsors
Leads: University Hospital Tuebingen
Collaborators: University Hospital of Cologne, University Hospital Lübeck

This content was sourced from clinicaltrials.gov

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