NCT01605578

Brief Summary

The purpose of this study is to compare, in healthy women, the adipose tissue composition between abdomen and thigh and then determine whether differences exist independently of the state of obesity. The findings of this study may help to explain the mechanism contributing to a beneficial role of gluteo-femoral fat contrasting with a deleterious role of abdominal fat on cardiovascular and metabolic dysfunctions.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
20

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started May 2012

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

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 11, 2012

Completed
3 days until next milestone

Study Start

First participant enrolled

May 14, 2012

Completed
11 days until next milestone

First Posted

Study publicly available on registry

May 25, 2012

Completed
7 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 14, 2012

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 14, 2012

Completed
Last Updated

September 4, 2025

Status Verified

March 1, 2025

Enrollment Period

7 months

First QC Date

May 11, 2012

Last Update Submit

August 27, 2025

Conditions

Adipose Tissue

Outcome Measures

Primary Outcomes (1)

  • To compare the number and the phenotype of cells between abdominal and gluteo-femoral adipose tissue in women.

    There is no time frame. It's a comparison of adipose tissue composition between two locations, collected both at visit 2 (inclusion).

Study Arms (1)

Non-menoposal healthy volunteer women aged between 25 to 45 years

OTHER

Adipose tissue biopsie (2-3g) have been taken by needle biopsy form the abdomen (periumbilical) and gluteo-femoral (upper thigh) levels

Procedure: Biopsies

Interventions

BiopsiesPROCEDURE

Abdominal and gluteo-femoral subcutaneous adipose tissue biopsies

Non-menoposal healthy volunteer women aged between 25 to 45 years

Eligibility Criteria

Age25 Years - 45 Years
Sexfemale
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • women between 15 and 45 years old
  • with genital activity
  • stable weight during the previous 3 months
  • BMI from 20 to 28
  • regular menstrual cycles (28 +/- 2 days) during the previous 3 months
  • reliable means of contraception (systemic hormonal contraception, intrauterine contraceptive device, tubal ligation)
  • using the same way of contraception during the previous 3 months
  • normal clinical examination
  • able to be compliant with the schedule of protocol assessments
  • willing and able to provide written informed consent
  • affiliated to a National Health Service
  • agreeing to being registered on the national file for subjects participating in biomedical research

You may not qualify if:

  • type I and II diabetes
  • early menopause
  • serious psychological disorders
  • uncontrolled thyroid disorders
  • know allergy to local anesthetics especially Xylocaine
  • abnormal laboratory results
  • medical history that, in the opinion of the investigator, makes the subject unsuitable for enrollment
  • positive test result for HIV, HCV and/or HBV virus
  • positive pregnancy test
  • smoking \> 10 cigarettes per day
  • smoking cessation during the previous 3 months
  • weight fluctuation (\>3kg) during the previous 3 months
  • alcohol abuse
  • coffee or tea consumption \> 6 cups per day
  • high consumption of drinks comprising xanthine bases (\>0.5 liters/day)
  • +15 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Centre d'Investigation Clinique, CHU Purpan

Toulouse, 31059, France

Location

Related Publications (1)

  • Gao H, Volat F, Sandhow L, Galitzky J, Nguyen T, Esteve D, Astrom G, Mejhert N, Ledoux S, Thalamas C, Arner P, Guillemot JC, Qian H, Ryden M, Bouloumie A. CD36 Is a Marker of Human Adipocyte Progenitors with Pronounced Adipogenic and Triglyceride Accumulation Potential. Stem Cells. 2017 Jul;35(7):1799-1814. doi: 10.1002/stem.2635. Epub 2017 May 18.

    PMID: 28470788BACKGROUND

MeSH Terms

Interventions

Biopsy

Intervention Hierarchy (Ancestors)

CytodiagnosisCytological TechniquesClinical Laboratory TechniquesDiagnostic Techniques and ProceduresDiagnosisSpecimen HandlingDiagnostic Techniques, SurgicalSurgical Procedures, OperativeInvestigative Techniques

Study Officials

  • Claire Thalamas, Doctor

    CHU Purpan (Toulouse)

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Purpose
BASIC SCIENCE
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER GOV
Responsible Party
SPONSOR

Study Record Dates

First Submitted

May 11, 2012

First Posted

May 25, 2012

Study Start

May 14, 2012

Primary Completion

December 14, 2012

Study Completion

December 14, 2012

Last Updated

September 4, 2025

Record last verified: 2025-03

Locations

FR(1)