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

NCT03974139 · Status: RECRUITING · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 31

Last updated 2023-10-31

No results posted yet for this study

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.

Conditions

  • Obesity Without Type 2 Diabetes, With BMI>30

Interventions

DRUG

Metformin Oral Tablet

Day 1 to day 3: 500 mg/day Day 4 to day 6: 500 mg/twice a day Day 7 to day 9: 500 mg three times a day Day 10 until next lumbar puncture : 850 mg three times a day

Sponsors & Collaborators

  • Centre Hospitalier Arras

    collaborator OTHER

  • Lille Catholic University

    lead OTHER

Principal Investigators

  • Vincent Prévot, PhD · Institut National de la Santé Et de la Recherche Médicale, France

  • Vincent Florent, MD, MSc, PhD · Centre Hospitalier d'Arras, INSERM

Study Design

Allocation
NA
Purpose
BASIC_SCIENCE
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Max Age
40 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2020-07-03
Primary Completion
2024-06-15
Completion
2024-09-30

Countries

  • France

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03974139 on ClinicalTrials.gov