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Clinical Trial Details

Trial ID: L3358
Source ID: NCT03974139
Associated Drug: Metformin Oral Tablet
Title: Impact of Metformin on Leptin Transport in Cerebrospinal Fluid of Obese Patients
Acronym: LEPTOB
Status: RECRUITING
Study Results: NO
Results:
Conditions: Obesity Without Type 2 Diabetes, With BMI>30
Interventions: DRUG: Metformin Oral Tablet
Outcome Measures: Primary: cerebrospinal fluid /plasma leptin ratio, 3 months | Secondary: cerebrospinal fluid /plasma glucose ratio, at day 0, 3 months|cerebrospinal fluid /plasma glucagon like peptide 1 (GLP1) ratio, at day 0, 3 months|cerebrospinal fluid /plasma insulin ratio, 3 months|cerebrospinal fluid /plasma ghrelin ratio, at day 0, 3 months|Cerebrospinal fluid levels of Agouti-Related Peptide (AgRP), at day 0, 3 months|Plasma levels of Agouti-Related Peptide (AgRP), at day 0, 3 months|Cerebrospinal fluid levels of proopiomelanocortin (POMC), at day 0, 3 months|Plasma levels of proopiomelanocortin (POMC), at day 0, 3 months|Cerebrospinal fluid levels of neuropeptide Y (NPY), at day 0, 3 months|Plasma levels of neuropeptide Y (NPY), at day 0, 3 months|Cerebrospinal fluid levels of leptin soluble receptor, at day 0, 3 months|Plasma levels of leptin soluble receptor, at day 0, 3 months|Apparent diffusion coefficient (ADC), Apparent diffusion coefficient (ADC) is a measure of the magnitude of diffusion (of water molecules) within tissue, and is commonly clinically calculated using Magnetic resonance imaging (MRI). An ADC of a tissue is expressed in units of mm2/s, at day 0, 3 months|Hypothalamic concentration of N-acetyl-aspartate (NAA), This concentration will be measure by spectroscopy, at day 0, 3 months|Hypothalamic concentration of creatine, This concentration will be measure by spectroscopy, at day 0, 3 months|Hypothalamic concentration of Choline, This concentration will be measure by spectroscopy, 3 months|Hypothalamic concentration of Glutamine / glutamate, This concentration will be measure by spectroscopy, at day 0, 3 months|Hypothalamic concentration of gamma-aminobutyric acid (GABA), This concentration will be measure by spectroscopy, at day 0, 3 months|Weight, at day 0, 3 months|Abdominal circumference, 3 months|Percentage of body fat, This parameter will measure by bioelectrical impedance analysis (BIA). A weak electric current flows through the body and the voltage is measured in order to calculate impedance (resistance) of the body., at day 0, 3 months|Fat free mass (Kg), This parameter will measure by bioelectrical impedance analysis (BIA). A weak electric current flows through the body and the voltage is measured in order to calculate impedance (resistance) of the body., at day 0, 3 months|Energy expenditure, This parameter will measure by indirect calorimetry (kCal / 24h), at day 0, 3 months|Score of the Three Factor Eating Questionnaire (TFEQ), The TFEQ contains 51 items and measures three dimensions of eating behavior: * cognitive restraint of eating' (Factor I - 21 items) * disinhibition (Factor II - 16 items) * hunger (Factor III - 14 items) Each item scores either 0 or 1 point. The minimum score for factors I-II-III is therefore 0-0-0, the possible maximum score 21-16-14, 3 months|Score of the Dutch Eating Behaviour Questionnaire (DEBQ), This is a 33-item self-report questionnaire to assess three distinct eating behaviors in adults: (1) emotional eating, (2) external eating, and (3) restrained eating. Items on the DEBQ range from 1 (never) to 5 (very often), with higher scores indicating greater endorsement of the eating behavior., at day 0, 3 months
Sponsor/Collaborators: Sponsor: Lille Catholic University | Collaborators: Centre Hospitalier Arras
Gender: ALL
Age: ADULT
Phases: PHASE2
Enrollment: 31
Study Type: INTERVENTIONAL
Study Designs: Allocation: NA|Intervention Model: SINGLE_GROUP|Masking: NONE|Primary Purpose: BASIC_SCIENCE
Start Date: 2020-07-03
Completion Date: 2024-09-30
Results First Posted:
Last Update Posted: 2023-10-31
Locations: Centre hospitalier d'Arras, Arras, 62022, France
URL: https://clinicaltrials.gov/show/NCT03974139