Impact of metformin on leptin in the cerebrospinal fluid of obese patients
- Conditions
- MedDRA version: 20.0Level: PTClassification code 10029883Term: ObesitySystem Organ Class: 10027433 - Metabolism and nutrition disordersOBESITY (BMI > 30)Therapeutic area: Body processes [G] - Metabolic Phenomena [G03]
- Registration Number
- EUCTR2017-000082-72-FR
- Lead Sponsor
- Groupement des Hôpitaux de l'Institut Catholique de Lille (GHICL)
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- All
- Target Recruitment
- 31
- Male or female aged > = 18 and < = 40 years
- Patient having an obesity with BMI > 30
- Patient beneficiary of the French National Health Fund
- Patient having agreed to take part in the study and having signed written consent form
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 31
F.1.3 Elderly (>=65 years) no
F.1.3.1 Number of subjects for this age range
-Type 2 diabetes defined by 2 fasting blood glucose > 1,26 g/L or blood glucose > 2g/L at 120min of oral glucose tolerance test with 75g of glucose)
- Glucose intolerance (fasting blood glucose between 1,10g/L and 1,26g/L or blood glucose between 1,40g/L and 2g/L at 120 minutes of oral glucose tolerance test with 75g of glucose)
- Patients who are already treated with metformin
- Type 1 diabetes
- Active neoplastic pathology whose diagnosis is <5 years or under treatment
- Neurological pathology (demyelinating, tumoral, vascular)
- Pathology of adipose tissue (lipodystrophy)
- History of bariatric surgery
- Contraindication to metformin at the maximum dose
- Contraindication to lumbar puncture
- Contraindication to MRI
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method