Adipose TissueNCT01605578
Description of Abdominal and Gluteo-femoral Subcutaneous Adipose Tissue Cell Population in Women - GLUTAB
A study testing Biopsies in people with Adipose Tissue, run by Institut National de la Santé Et de la Recherche Médicale, France at 1 site in France.
Trial 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. Read more about this study
- Who is it for?
- Ages 25 to 45 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Adipose Tissue
- What is being tested?
- Biopsies
- Type of treatment
- Injection or infusion, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 1 siteFrance
- Study dates
- 14 May 2012to 14 Dec 2012
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 25 to 45 years
- Women only
- Healthy volunteers accepted
- Adult
Who may be able to join
- 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)
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- 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
Who cannot join
- Exclusions related to significant medical disturbances :
- type I and II diabetes
- early menopause
- serious psychological disorders
- uncontrolled thyroid disorders
- know allergy to local anesthetics especially Xylocaine
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- 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
- Exclusions related to subject lifestyle :
- 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)
- consumption of drinks (water or herbal teas) > 2 liters per day
- Exclusions related to previous or concomitant treatments :
- anticoagulant
- neuroleptic or antidepressant
- medication with draining, lipolytic, appetite suppressant and/or slimming effect
- local or systemic corticosteroid therapy on the test areas
- hormonal treatment other than contraception
- diuretic
- local treatment against cellulitis (mesotherapy,phosphatidylcholine injection, mechanical process)
- thighs liposuction < 2 years
- chronic treatment with anti-inflammatory
- Exclusions related to the subject :
- unwillingness or inability to comply with the requirements of the protocol
- previous participation in a clinical trial within 30 days
- inability to understand and sign the consent due to linguistic or psychic issues
- subject deprived of liberty or under guardianship, tutorship or judicial protection
- female who are currently pregnant or breastfeeding or female considering becoming pregnant while in the study
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Description Des Populations Cellulaires Des Tissus Adipeux Sous-cutanés Abdominaux et glutéo-fémoraux Chez la Femme.
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.
- Conditions
- Adipose Tissue
- Being tested
- Biopsies
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
BiopsiesProcedure or surgery
Abdominal and gluteo-femoral subcutaneous adipose tissue biopsies
| Study group | Role | What they receive |
|---|---|---|
| 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 Receives: Procedure: Biopsies |
What is being measured
The primary outcome is the main question the study is designed to answer.
To compare the number and the phenotype of cells between abdominal and gluteo-femoral adipose tissue in women.
Measured: There is no time frame. It's a comparison of adipose tissue composition between two locations, collected both at visit 2 (inclusion).
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 May 2012 (estimated)
- Study start14 May 2012
- Primary completion14 Dec 2012
- Study completion14 Dec 2012
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Adipose TissueStudies of the same condition, open and under way.
- More trials run by Institut National de la Santé Et de la Recherche Médicale, FranceThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Basic science
- Allocation
- Not applicable
- Intervention model
- Single group
- Enrolment
- 20 participants (actual)
Sponsor and investigators
- Sponsor type
- Other government
- Responsible party
- Sponsor
- Investigators
- Claire Thalamas, Doctor, Principal investigator, CHU Purpan (Toulouse)
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01605578
- Sponsor's protocol ID
- C11-48
- Other IDs
- 2011-A01496-35
- Status last verified
- Mar 2025
- First submitted
- 11 May 2012
- Last updated
- 4 Sep 2025
- Results posted
- No
Publications
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.
PubMed 28470788
Study at a glance
From the registry record, last updated by the sponsor on 4 Sep 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Description Des Populations Cellulaires Des Tissus Adipeux Sous-cutanés Abdominaux et glutéo-fémoraux Chez la Femme.
- ClinicalTrials.gov ID
- NCT01605578
- Acronym / sponsor ID
- C11-48
- Conditions
- Adipose Tissue
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 20 participants (actual)
- Lead sponsor
- Institut National de la Santé Et de la Recherche Médicale, FranceOther government
- Study start
- 14 May 2012 (actual)
- Primary completion
- 14 Dec 2012 (actual)
- Study completion
- 14 Dec 2012 (actual)
- First posted
- 25 May 2012 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Basic science
- Allocation
- Not applicable
- Intervention model
- Single group
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Non-menoposal healthy volunteer women aged between 25 to 45 years | Other | Procedure: BiopsiesAdipose tissue biopsie (2-3g) have been taken by needle biopsy form the abdomen (periumbilical) and gluteo-femoral (upper thigh) levels |
Who may qualify
- Ages
- 25 to 45 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (12 listed)
- 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
Key exclusion criteria (34 listed)
- Exclusions related to significant medical disturbances :
- type I and II diabetes
- early menopause
- serious psychological disorders
- uncontrolled thyroid disorders
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| BiopsiesAbdominal and gluteo-femoral subcutaneous adipose tissue biopsies | Procedure or surgery | Non-menoposal healthy volunteer women aged between 25 to 45 years |
Primary outcome
To compare the number and the phenotype of cells between abdominal and gluteo-femoral adipose tissue in women.
Time frame: There is no time frame. It's a comparison of adipose tissue composition between two locations, collected both at visit 2 (inclusion).
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Sep 2025.
- Results publication: PubMed 28470788Gao 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Claire Thalamas, Doctor principal investigator
CHU Purpan (Toulouse)
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Biopsies in people with Adipose Tissue, run by Institut National de la Santé Et de la Recherche Médicale, France at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 12 inclusion and 34 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 4 Sep 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
To compare the number and the phenotype of cells between abdominal and gluteo-femoral adipose tissue in women. (time frame: There is no time frame. It's a comparison of adipose tissue composition between two locations, collected both at visit 2 (inclusion).). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01605578, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 Sep 2025.