Effects of Metformin on Leptin Levels in Obese Patients
Study of the Communication of the Hypothalamus With the Periphery: Impact of Metformin on Leptin Transport in the Cerebrospinal Fluid of Obese Patients. A Monocentric Prospective Study
This study is testing whether metformin can help obese patients by improving how leptin moves into the brain, which might help control their appetite and energy use.
Quick facts
| Phase | Phase 2 |
|---|---|
| Study type | Interventional |
| Enrollment | 31 (estimated) |
| Ages | 18 Years to 40 Years |
| Sex | All |
| Sponsor | Lille Catholic University Academic / other |
| Locations | 1 site (Arras) |
| Trial ID | NCT03974139 on ClinicalTrials.gov |
What this trial studies
This study investigates how metformin, a medication commonly used for diabetes, affects the transport of leptin in the cerebrospinal fluid (CSF) of obese patients. It aims to determine whether metformin can improve the transport of leptin into the brain, which may help regulate appetite and energy expenditure. Participants will undergo blood and CSF sampling, MRI assessments, and cognitive tests before and after a 3-month treatment with metformin. The study is designed to explore the relationship between leptin transport and metabolic activity in the hypothalamus.
Who should consider this trial
Good fit: Ideal candidates are adults aged 18 to 40 with a body mass index greater than 30 who are not diabetic.
Not a fit: Patients with type 2 diabetes, genetic obesity, or those who have undergone bariatric surgery are unlikely to benefit from this study.
Why it matters
Potential benefit: If successful, this study could provide a new treatment approach for obesity by enhancing leptin signaling in the brain.
How similar studies have performed: While the approach of using metformin for obesity management is novel, similar studies have shown potential in modulating metabolic signals.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Adults between 18 and 40 years old * Body mass index \>30 * For childbearing age women: use of an effective contraceptive method for the duration of the study * Patients willing to participate in the study and who have signed the informed consent form * Patients with health insurance Exclusion Criteria: * Genetic obesity * Type 2 diabetes defined by 2 fasting blood glucose \>1,26g/L or blood glucose \>2 g/L at 120 min of oral glucose tolerance test with 75 g of glucose * Patients already treated with metformin * Type 1 diabetes * Active neoplastic pathology, diagnosed \< 5 years, or in treatment * Neurological pathology (demyelinating, tumor, vascular) * Adipose tissue pathology (lipodystrophy) * History of bariatric surgery * Contraindication to metformin * Lumbar puncture contraindication * MRI contraindication * Person unable to consent, or benefiting from a legal protection regime (guardianship/curatorship/guardianship of justice) * Pregnant or breastfeeding woman * Contra-indication to impedance measurement * Contraindication to indirect calorimetry: claustrophobia * Taking a psychotropic drug
Where this trial is running
Arras
- Centre hospitalier d'Arras — Arras, France (Recruiting)
Study contacts
- Principal investigator: Vincent Florent, MD, MSc, PhD — Centre Hospitalier d'Arras, INSERM
- Study coordinator: Amélie Lansiaux, MD, PhD
- Email: lansiaux.amelie@ghcl.net
- Phone: 0033320225741
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.