Impact of Metformin on Leptin Transport in Cerebrospinal Fluid of Obese Patients

• Status: Recruiting
• Trial end date: 2022-05-31
• Target enrollment: 0
• Participant gender: All

Summary

Obesity, a major health problem, is gradually transforming into a global epidemic. The current obesity treatment with long term efficacy is the bariatric surgery, however, the operative risk of this procedure is high and the post-operative iotrogeny may be important. Obesity is most often associated to the feeding behavior which depends on hypothalamic integration of peripheral signals such as leptin and glucose. High levels of circulating leptin are detected in obese patients. These elevated leptin levels fail to reduce appetite or increase energy expenditure. The mechanism underlying this non-integration of peripheral signals remains to be identified. The ratio of leptin levels in the cereprospinal fluid (CSF) and in the periphery is drastically decreased in obese patients when compared to lean individuals, therefore a defective transport of circulating leptin into the brain via the CSF is maybe linked to obesity.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Lille Catholic University
• Collaborator: Centre Hospitalier Arras
• Treatments: Metformin

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

• Patients already treated with metformin

• 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

• Glucose intolerance (fasting blood glucose between 1,10 g/L and 1,26 g/L or blood glucose between 1,40 g/L and 2g/L at 120 minutes of oral glucose tolerance test with 75 g of glucose)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