NCT03974139

Brief 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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
31

participants targeted

Target at P25-P50 for phase_2

Timeline
Completed

Started Jul 2020

Typical duration for phase_2

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

May 28, 2019

Completed
7 days until next milestone

First Posted

Study publicly available on registry

June 4, 2019

Completed
1.1 years until next milestone

Study Start

First participant enrolled

July 3, 2020

Completed
4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 15, 2024

Completed
4 months until next milestone

Study Completion

Last participant's last visit for all outcomes

September 30, 2024

Completed
Last Updated

October 31, 2023

Status Verified

October 1, 2023

Enrollment Period

4 years

First QC Date

May 28, 2019

Last Update Submit

October 30, 2023

Conditions

Obesity Without Type 2 Diabetes, With BMI>30

Keywords

metforminleptincerebrospinal fluid

Outcome Measures

Primary Outcomes (1)

  • cerebrospinal fluid /plasma leptin ratio

    3 months

Secondary Outcomes (25)

  • 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

  • +20 more secondary outcomes

Study Arms (1)

Obese patients

EXPERIMENTAL

Patients with body mass index \>30

Drug: Metformin Oral Tablet

Interventions

Metformin Oral TabletDRUG

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

Obese patients

Eligibility Criteria

Age18 Years - 40 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • 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

You may not qualify if:

  • Genetic obesity
  • 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
  • Patients already treated with metformin
  • Type 1 diabetes
  • 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
  • +1 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Centre hospitalier d'Arras

Arras, 62022, France

RECRUITING

MeSH Terms

Interventions

Metformin

Intervention Hierarchy (Ancestors)

BiguanidesGuanidinesAmidinesOrganic Chemicals

Study Officials

  • Vincent Prévot, PhD

    Institut National de la Santé Et de la Recherche Médicale, France

    STUDY DIRECTOR

  • Vincent Florent, MD, MSc, PhD

    Centre Hospitalier d'Arras, INSERM

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Amélie Lansiaux, MD, PhD

CONTACT

0033320225741lansiaux.amelie@ghcl.net

Melody Plets, MSc

CONTACT

0033320225733plets.melody@ghicl.net

Study Design

Study Type
interventional
Phase
phase 2
Allocation
NA
Masking
NONE
Purpose
BASIC SCIENCE
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

May 28, 2019

First Posted

June 4, 2019

Study Start

July 3, 2020

Primary Completion

June 15, 2024

Study Completion

September 30, 2024

Last Updated

October 31, 2023

Record last verified: 2023-10

Locations

FR(1)