Dopamine Action on Metabolism in Relation to Genotype

Launched by UNIVERSITY HOSPITAL TUEBINGEN · May 2, 2018

Keywords

ClinConnect Summary

This clinical trial is studying how a medication called bromocriptine can help with weight loss in people who are obese, particularly focusing on those with a specific genetic background. Researchers want to see if those with a certain genetic variant related to body weight will respond better to bromocriptine compared to those without that variant. The goal is to find a more personalized approach to treating obesity, which affects many people and can lead to serious health issues.

To participate in the trial, individuals must be at least 18 years old and have a body mass index (BMI) over 30, which indicates obesity. They should also be able to understand and sign a consent form. Participants will be divided into two groups: one will receive bromocriptine, and the other will receive a placebo (a pill with no active medication). The treatment will last for 18 weeks, with a follow-up after 30 weeks. It’s important to note that there are some health conditions that would exclude someone from participating, such as diabetes or certain heart problems. This trial aims to explore a new, individualized treatment option for obesity with minimal side effects.

Gender

ALL

Eligibility criteria

• Inclusion Criteria:
• • 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.
• Exclusion Criteria:
• • Women during pregnancy and lactation.
• • History of hypersensitivity to the investigational medicinal product or to any drug with similar chemical structure or to any excipient present in the pharmaceutical form of the investigational medicinal products.
• • Participation in other clinical trials or observation period of competing trials up to 30 days prior to this study.
• • Diabetes mellitus
• • Treatment with Methyldopa, levodopa, dopamine agonists, metoclopramid, domperidon, glycerol nitrate, griseofulvin, azol-antimycotic drugs, macrolide-antibiotics, octreotide, orlistat, tamoxifen, liraglutide
• • Any relevant cardiovascular disease, e.g. myocardial infarction, acute coronary syndrome, unstable angina pectoris, Percutaneous transluminal coronary angioplasty (PTCA), heart failure (NYHA III-IV), stroke or transient ischemic attack (TIA)
• • Acute or chronic viral hepatitis or liver cirrhosis
• • Impaired renal function, defined as estimated Glomerular Filtration Rate (eGFR) ≤ 60 ml/min (MDRD formula) as determined during screening.
• • Medical history of cancer and/or treatment for cancer within the last 5 years.
• • Claustrophobia
• • Any other clinically significant major organ system disease at screening such as relevant gastrointestinal, neurologic, psychiatric, endocrine (i.e. pancreatic), hematologic, malignant, infection or other major systemic diseases making implementation of the protocol or interpretation of the study results difficult.
• • Presence of any contraindication for the conduct of an MRI investigation, such as cardiac pacemakers, ferromagnetic haemostatic clips in the central nervous system, metallic splinters in the eye, ferromagnetic or electronically operated active devices like automatic cardioverter defibrillators, cochlear implants, insulin pumps and nerve stimulators, prosthetic heart valves etc.
• • hyperthyroidism
• • therapy refractary hypertension
• • peripheral arterial disease
• • Parkinson´s disease
• • Known current presence or history of one of the following psychiatric diseases: depression, mania, anxiety and panic disorder, obsessive-compulsive disorder, schizophrenia, psychosis, addiction
• • pituitary disease
• • treatment with bromocriptine during 12 month before entering the trial
• • dementia
• • gastric or intestinal ulcer
• • Persons with limited temperature sensation and / or elevated sensitivity to warming of the body
• • Persons with a hearing disorder or a increased sensitivity for loud noises
• • smoking
• • Refusal to get informed of unexpected detected pathological findings
• • Any other clinical condition that would jeopardize subjects' safety while participating in this clinical trial.