OBESITY (BMI > 30) MedDRA version: 20.0 Level: PT Classification code 10029883 Term: Obesity System Organ Class: 10027433 - Metabolism and nutrition disorders
Conditions
Interventions
Trade Name: Metformine Sandoz 500 mg
Product Name: Metformine chlorhydrate
Pharmaceutical Form: Tablet
INN or Proposed INN: METFORMIN HYDROCHLORIDE
CAS Number: 1115-70-4
Concentration unit: mg milligr
Sponsors
Groupement des Hôpitaux de l'Institut Catholique de Lille (GHICL)
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: - Male or female aged > = 18 and 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
Exclusion criteria
Exclusion criteria: -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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: Study the impact of metformin in obese patients on blood and cerebrospinal fluid concentrations of leptin. ;Secondary Objective: Study the impact of the metformine at obese patients on: 1. Other molecules involved in the regulation of the food intake and in the axis "bowel-brain", during the migration of the signal leptin through tanycytes, 2. Cerebral neurotransmitters involved in the regulation of the food intake, 3. Of the travel of water molecules within the hypothalamus as well as the direction of these travels during a sequence MRI of distribution, 4. Of the neurobiological and biochemical contents of the in vivo hypothalamus by spectroscopy RM, 5. Anthropometric parameters, 6. Of physical composition, 7. Of energy expenditure 8. Of the behavior and the food intake 9. Parameters of the carbohydrate metabolism, lipid metabolism, hepatic metabolism 10. Estimate safety of the metformin treatment;Primary end point(s): Ratio of cerebrospinal fluid (CSF) concentration of leptin to blood concentration of leptin;Timepoint(s) of evaluation of this end point: At 3 months | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): 1. Measure of the following ratios: a. CSF glucose / fasting blood glucose b. CSF GLP1 / fasting blood GLP1 c. CSF insulin / fasting blood insulin d. CSF ghrelin/ fasting blood ghrelin 2. Fasting plasma and CSF concentrations of : a. AgRP b. POMC c. PY d. soluble leptin receptor 3. Apparent diffusion coefficient (ADC) obtained by diffusion MRI (performed on an empty stomach). 4. Fasting hypothalamic metabolites concentrations measured by magnetic resonance spectroscopy : a. N-acetyl-aspartate NAA, b. Creatine Cr, c. Choline Cho. d. Glutamine / glutamate e. GABA 5. Anthropometric parameters (weight, waist circumference), 6. Body composition measured by bioelectrical impedance analysis in kg and % of fat mass, fat-free mass, and phase angle in degrees 7. Energy expenditure measured by indirect calorimetry in kCal / 24h 8. Eating Behavior questionnaires scores (TFEQ, DEBQ) balanced by a test of cognitive efficiency (MMSE) and dietary survey with food ingested in kCal/24h. 9. Blood tests: a. Lipid levels (Total cholesterol, HDL cholesterol, LDL cholesterol, Triglycerides), b. Glucose levels (fasting blood glucose, glycated hemoglobin), c. Liver function values (AST, ALT, GGT, ALP). 10. Safety of treatment measured using NCI-CTCAE v4.0 criteria (gastrointestinal disturbances (nausea, vomiting, diarrhea), skin reaction (erythema, pruritis, urticaria)). ;Timepoint(s) of evaluation of this end point: At Month 0 and month 3 | — |
Countries
France
Contacts
Public ContactDRCI (Mélody PLETS)
GHICL
Outcome results
None listed