ObesityEiffel 2NCT02728635

Epigenetic Regulation of Human Adipose Tissue Distribution

A study testing Dual-energy X-ray absorptiometry (DEXA)/ Magnetic resonance imaging (MRI) and Magnetic resonance spectroscopy (MRS), Adipose tissue biopsies and FSIGTT/ RMR in people with Obesity, run by AdventHealth Translational Research Institute at 1 site in United States.

Active, not recruiting

Under way, not looking for participants. Everyone needed has enrolled. The study is still running.

Official record

Search all trials

Trial summary

The purpose of this study is to collect data to help researchers better understand the different ways that women or men store fat (apple shape versus pear shape). Read more about this study

Who is it for?: Ages 18 to 45 yearsHealthy volunteers can take part
Conditions the study is for: Obesity
What is being tested?: Dual-energy X-ray absorptiometry (DEXA)/ Magnetic resonance imaging (MRI) and Magnetic resonance spectroscopy (MRS), Adipose tissue biopsies and FSIGTT/ RMR
Type of treatment: Injection or infusion, Surgery or procedure
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 27 participants
Where: 1 siteUnited States
Study dates: Jul 2016to Dec 2026
Phase: Interventional
Are there results?: Not yet: the study is under way

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 18 to 45 years
All sexes
Healthy volunteers accepted
Adult

Who may be able to join

Age 18-45 years inclusive;
BMI 23-35 kg/m2 inclusive;
HbA1C <6.0%;
Weight stable (± 3 kg) during the 3 months prior to enrollment;
Women must be > 9 months post-partum;
Able to provide written, informed consent.

Who cannot join

Postmenopausal women
Women with an oophorectomy
Fasting plasma glucose > 126 mg/dL, or diagnosis with Type 2 Diabetes (T2DM)
Untreated or symptomatic thyroid disease.
Aminotransferase or aspartate aminotransferase > 3x upper limit of laboratory reference range, or known diagnosis of liver disease.
Creatinine > 2x upper limit of laboratory reference range, or known diagnosis of kidney disease.

Show all 21Show fewer

Uncontrolled hypertension (BP > 140 systolic or > 90 diastolic)
New onset (<3 months on a stable regime) use of oral contraceptives or hormone replacement therapy.
History of drug or alcohol abuse (> 3 drinks per day) within the last 5 years, or psychiatric disease prohibiting adherence to study protocol. Current drug use may be determine by plasma or urine drug screens.
History of cancer within the last 5 years (skin cancers, with the exception of melanoma, may be acceptable).
History of organ transplant.
Myocardial Infarction within the last 6 months.
Current treatment with blood thinners or antiplatelet medications that cannot be safely stopped for biopsy and testing procedures.
History of HIV, active Hepatitis B or C or tuberculosis
Presence of clinically significant abnormalities on EKG.
Current smokers (smoking within the past 3 months).
Use of any medications known to influence glucose, fat and/or energy metabolism within the last 3 months (eg. growth hormone therapy, glucocorticoids [steroids], etc.)
Other chronic or acute illness that might affect study results / interpretation in the opinion of the clinical
Other items related to procedural risk (outlined below) such as bleeding disorder, claustrophobia, etc.
Elevated high sensitivity c-reactive protein or known active infection.
There are some implants which are MR compatible (safe) but would cause artifacts which could obscure our ability to measure an organ, e.g. full braces may negate the ability to measure brain size.

Trial locations and contacts

1 site in 1 country.

United States1 site

Translational Research Institute for Metabolism and Diabetes
Orlando, Florida, 32804

Other trials in United States

About this study

The purpose of this study is to collect data to help researchers better understand the different ways that women or men store fat (apple shape versus pear shape).

Conditions: Obesity
Being tested: Dual-energy X-ray absorptiometry (DEXA)/ Magnetic resonance imaging (MRI) and Magnetic resonance spectroscopy (MRS), Adipose tissue biopsies, FSIGTT/ RMR
Keywords: Adipose tissue, epigenetic, abdominal gluteal fat
Medical subject headings: Obesity

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Dual-energy X-ray absorptiometry (DEXA)/ Magnetic resonance imaging (MRI) and Magnetic resonance spectroscopy (MRS)Other
A DEXA scan for body composition will also be completed. After a MRI safety screening a whole body MRI for the volumetric measurement of visceral fat, subcutaneous fat, liver, kidneys, heart, brain, skeletal muscle and intramuscular adipose tissue (IMAT) and hepatic lipid by MRS will be performed. Whole body imaging will include low resolution positioning images, followed by several sets of 3D images which will be digitally connected to create a 3D image the entire length of the body. The liver spectroscopy will be performed using PRESS (point resolved spectroscopy) and STEAM (Stimulated Echo Acquisition Mode) sequence during the same imaging session, using the whole body images for positioning.
Adipose tissue biopsiesProcedure or surgery
Two biopsies will be performed to collect fat tissue from the abdomen and thigh region.
FSIGTT/ RMROther
Insertion of two intravenous (IV) catheters for performing a Frequently Sampled Intravenous Glucose Tolerance Test (FSIGTT) to measure the acute insulin response to glucose (AIRg) and insulin sensitivity (Si) will be performed. Resting metabolic rate (RMR) will be used to measure metabolic flexibility. Point of care blood glucose measurements will be taken frequently to ensure safety.

Study groups in NCT02728635
Study group	Role	What they receive
Group A- Women- Healthy 'pears'	Active comparator	This group will consist of healthy women with a BMI between 23 and 35 kg/m2 as a waist-to-hip ratio of 0.78 or less. Receives: Other: Dual-energy X-ray absorptiometry (DEXA)/ Magnetic resonance imaging (MRI) and Magnetic resonance spectroscopy (MRS); Procedure: Adipose tissue biopsies; Other: FSIGTT/ RMR
Group B- Women- Healthy 'apples'	Active comparator	The group will consist of healthy women with a BMI between 23 and 35 kg/m2 as a waist-to-hip ratio of 0.85 or more. Receives: Other: Dual-energy X-ray absorptiometry (DEXA)/ Magnetic resonance imaging (MRI) and Magnetic resonance spectroscopy (MRS); Procedure: Adipose tissue biopsies; Other: FSIGTT/ RMR
Group C- Men- Healthy 'apples'	Active comparator	The group will consist of men with a BMI between 23 and 35 kg/m2. Receives: Other: Dual-energy X-ray absorptiometry (DEXA)/ Magnetic resonance imaging (MRI) and Magnetic resonance spectroscopy (MRS); Procedure: Adipose tissue biopsies; Other: FSIGTT/ RMR

What is being measured

The primary outcome is the main question the study is designed to answer.

Epigenetic marks in abdominal vs gluteal subcutaneous adipose tissue and adipocytes
The preadipocytes obtained from biopsies of Abdominal Fat and Gluteofemoral Fat from patients in the 'pears' woman, 'apple' women and men will be cultured by our standard methods in proliferative medium followed by our standard protocol for differentiation into mature adipocytes. We propose to evaluate samples from 3 individuals from each Group to identify a large number of differentially regulated regions genome wide. All the data obtained in vitro in culture cells will be compared with the data obtained from RNA and chromatin isolated from the whole tissue Abdominal fat and Gluteofemoral fat biopsies
Measured: 6 weeks

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

Jul 2016Dec 2026

First posted5 Apr 2016 (estimated)
Study startJul 2016
Primary completion11 Jul 2018
Study completionDec 2026 (estimated)

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Publications (38)Papers the sponsor has linked to this study.
Other trials for ObesityStudies of the same condition, open and under way.
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: Non-randomised
Intervention model: Single group
Masking: None (open label)
Enrolment: 27 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT02728635
Sponsor's protocol ID: TRIMDFH 869496
Acronym: Eiffel 2
Status last verified: Mar 2026
First submitted: 24 Mar 2016
Last updated: 27 Mar 2026
Results posted: No
Data monitoring committee: Yes
Individual data sharing: No

Publications

Jensen MD, Ryan DH, Apovian CM, Ard JD, Comuzzie AG, Donato KA, Hu FB, Hubbard VS, Jakicic JM, Kushner RF, Loria CM, Millen BE, Nonas CA, Pi-Sunyer FX, Stevens J, Stevens VJ, Wadden TA, Wolfe BM, Yanovski SZ; American College of Cardiology/American Heart Association Task Force on Practice Guidelines; Obesity Society. 2013 AHA/ACC/TOS guideline for the management of overweight and obesity in adults: a report of the American College of Cardiology/American Heart Association Task Force on Practice Guidelines and The Obesity Society. J Am Coll Cardiol. 2014 Jul 1;63(25 Pt B):2985-3023. doi: 10.1016/j.jacc.2013.11.004. Epub 2013 Nov 12. No abstract available.
PubMed 24239920
McAllister EJ, Dhurandhar NV, Keith SW, Aronne LJ, Barger J, Baskin M, Benca RM, Biggio J, Boggiano MM, Eisenmann JC, Elobeid M, Fontaine KR, Gluckman P, Hanlon EC, Katzmarzyk P, Pietrobelli A, Redden DT, Ruden DM, Wang C, Waterland RA, Wright SM, Allison DB. Ten putative contributors to the obesity epidemic. Crit Rev Food Sci Nutr. 2009 Nov;49(10):868-913. doi: 10.1080/10408390903372599.
PubMed 19960394
Roberson L, Shaharyar S, Aneni E, Freitas W, Blaha M, Agatston A, Blumenthal R, Santos RD, Feiz H, Nasir K, Sposito A. The prevalence of the metabolically healthy obese phenotype in an aging population and its association with subclinical cardiovascular disease: The Brazilian study on healthy aging. Diabetol Metab Syndr. 2014 Nov 7;6(1):121. doi: 10.1186/1758-5996-6-121. eCollection 2014.
PubMed 25411583
Roberson LL, Aneni EC, Maziak W, Agatston A, Feldman T, Rouseff M, Tran T, Blaha MJ, Santos RD, Sposito A, Al-Mallah MH, Blankstein R, Budoff MJ, Nasir K. Beyond BMI: The "Metabolically healthy obese" phenotype & its association with clinical/subclinical cardiovascular disease and all-cause mortality -- a systematic review. BMC Public Health. 2014 Jan 8;14:14. doi: 10.1186/1471-2458-14-14.
PubMed 24400816
de Koning L, Merchant AT, Pogue J, Anand SS. Waist circumference and waist-to-hip ratio as predictors of cardiovascular events: meta-regression analysis of prospective studies. Eur Heart J. 2007 Apr;28(7):850-6. doi: 10.1093/eurheartj/ehm026. Epub 2007 Apr 2.
PubMed 17403720
Qiao Q, Nyamdorj R. Is the association of type II diabetes with waist circumference or waist-to-hip ratio stronger than that with body mass index? Eur J Clin Nutr. 2010 Jan;64(1):30-4. doi: 10.1038/ejcn.2009.93. Epub 2009 Sep 2.
PubMed 19724291
Yusuf S, Hawken S, Ounpuu S, Bautista L, Franzosi MG, Commerford P, Lang CC, Rumboldt Z, Onen CL, Lisheng L, Tanomsup S, Wangai P Jr, Razak F, Sharma AM, Anand SS; INTERHEART Study Investigators. Obesity and the risk of myocardial infarction in 27,000 participants from 52 countries: a case-control study. Lancet. 2005 Nov 5;366(9497):1640-9. doi: 10.1016/S0140-6736(05)67663-5.
PubMed 16271645
VAGUE J. The degree of masculine differentiation of obesities: a factor determining predisposition to diabetes, atherosclerosis, gout, and uric calculous disease. Am J Clin Nutr. 1956 Jan-Feb;4(1):20-34. doi: 10.1093/ajcn/4.1.20. No abstract available.
PubMed 13282851
Vague J. Sexual differentiation. A determinant factor of the forms of obesity. 1947. Obes Res. 1996 Mar;4(2):201-3. doi: 10.1002/j.1550-8528.1996.tb00535.x. No abstract available.
PubMed 8681056
Santosa S, Jensen MD. Why are we shaped differently, and why does it matter? Am J Physiol Endocrinol Metab. 2008 Sep;295(3):E531-5. doi: 10.1152/ajpendo.90357.2008. Epub 2008 May 20.
PubMed 18492764
Fu J, Hofker M, Wijmenga C. Apple or pear: size and shape matter. Cell Metab. 2015 Apr 7;21(4):507-8. doi: 10.1016/j.cmet.2015.03.016.
PubMed 25863240
Manolopoulos KN, Karpe F, Frayn KN. Gluteofemoral body fat as a determinant of metabolic health. Int J Obes (Lond). 2010 Jun;34(6):949-59. doi: 10.1038/ijo.2009.286. Epub 2010 Jan 12.
PubMed 20065965
Weber RV, Buckley MC, Fried SK, Kral JG. Subcutaneous lipectomy causes a metabolic syndrome in hamsters. Am J Physiol Regul Integr Comp Physiol. 2000 Sep;279(3):R936-43. doi: 10.1152/ajpregu.2000.279.3.R936.
PubMed 10956251
Tran TT, Yamamoto Y, Gesta S, Kahn CR. Beneficial effects of subcutaneous fat transplantation on metabolism. Cell Metab. 2008 May;7(5):410-20. doi: 10.1016/j.cmet.2008.04.004.
PubMed 18460332
Elbers JM, Asscheman H, Seidell JC, Gooren LJ. Effects of sex steroid hormones on regional fat depots as assessed by magnetic resonance imaging in transsexuals. Am J Physiol. 1999 Feb;276(2):E317-25. doi: 10.1152/ajpendo.1999.276.2.E317.
PubMed 9950792

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

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Study at a glance

From the registry record, last updated by the sponsor on 27 Mar 2026. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Epigenetic Regulation of Human Adipose Tissue Distribution
ClinicalTrials.gov ID: NCT02728635
Acronym / sponsor ID: Eiffel 2 / TRIMDFH 869496
Conditions: Obesity
Keywords: Adipose tissue, epigenetic, abdominal gluteal fat
Study type: Interventional
Recruitment status: Active, not recruiting
Enrolment: 27 participants (actual)
Lead sponsor: AdventHealth Translational Research InstituteUniversity, hospital or other
Collaborators: Sanford-Burnham Medical Research Institute
Study start: Jul 2016 (actual)
Primary completion: 11 Jul 2018 (actual)
Study completion: Dec 2026 (estimated)
First posted: 5 Apr 2016 (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 collect data to help researchers better understand the different ways that women or men store fat (apple shape versus pear shape).

Study design

Primary purpose: Basic science
Allocation: Non-randomised
Intervention model: Single group
Masking: None (open label)
Number of arms: 3

Arm	Type	Receives
Group A- Women- Healthy 'pears'	Active comparator	Other: Dual-energy X-ray absorptiometry (DEXA)/ Magnetic resonance imaging (MRI) and Magnetic resonance spectroscopy (MRS), Procedure: Adipose tissue biopsies, Other: FSIGTT/ RMRThis group will consist of healthy women with a BMI between 23 and 35 kg/m2 as a waist-to-hip ratio of 0.78 or less.
Group B- Women- Healthy 'apples'	Active comparator	Other: Dual-energy X-ray absorptiometry (DEXA)/ Magnetic resonance imaging (MRI) and Magnetic resonance spectroscopy (MRS), Procedure: Adipose tissue biopsies, Other: FSIGTT/ RMRThe group will consist of healthy women with a BMI between 23 and 35 kg/m2 as a waist-to-hip ratio of 0.85 or more.
Group C- Men- Healthy 'apples'	Active comparator	Other: Dual-energy X-ray absorptiometry (DEXA)/ Magnetic resonance imaging (MRI) and Magnetic resonance spectroscopy (MRS), Procedure: Adipose tissue biopsies, Other: FSIGTT/ RMRThe group will consist of men with a BMI between 23 and 35 kg/m2.

Who may qualify

Ages: 18 to 45 years
Sex: All
Healthy volunteers: Accepted
Age groups: Adult

Key inclusion criteria (6 listed)

Age 18-45 years inclusive;
BMI 23-35 kg/m2 inclusive;
HbA1C <6.0%;
Weight stable (± 3 kg) during the 3 months prior to enrollment;
Women must be > 9 months post-partum;

Key exclusion criteria (21 listed)

Postmenopausal women
Women with an oophorectomy
Fasting plasma glucose > 126 mg/dL, or diagnosis with Type 2 Diabetes (T2DM)
Untreated or symptomatic thyroid disease.
Aminotransferase or aspartate aminotransferase > 3x upper limit of laboratory reference range, or known diagnosis of liver disease.

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
Dual-energy X-ray absorptiometry (DEXA)/ Magnetic resonance imaging (MRI) and Magnetic resonance spectroscopy (MRS)A DEXA scan for body composition will also be completed. After a MRI safety screening a whole body MRI for the volumetric measurement of visceral fat, subcutaneous fat, liver, kidneys, heart, brain, skeletal muscle and intramuscular adipose tissue (IMAT) and hepatic lipid by MRS will be performed. Whole body imaging will include low resolution positioning images, followed by several sets of 3D images which will be digitally connected to create a 3D image the entire length of the body. The liver spectroscopy will be performed using PRESS (point resolved spectroscopy) and STEAM (Stimulated Echo Acquisition Mode) sequence during the same imaging session, using the whole body images for positioning.	Other	Group A- Women- Healthy 'pears', Group B- Women- Healthy 'apples', Group C- Men- Healthy 'apples'
Adipose tissue biopsiesTwo biopsies will be performed to collect fat tissue from the abdomen and thigh region.	Procedure or surgery	Group A- Women- Healthy 'pears', Group B- Women- Healthy 'apples', Group C- Men- Healthy 'apples'
FSIGTT/ RMRInsertion of two intravenous (IV) catheters for performing a Frequently Sampled Intravenous Glucose Tolerance Test (FSIGTT) to measure the acute insulin response to glucose (AIRg) and insulin sensitivity (Si) will be performed. Resting metabolic rate (RMR) will be used to measure metabolic flexibility. Point of care blood glucose measurements will be taken frequently to ensure safety.	Other	Group A- Women- Healthy 'pears', Group B- Women- Healthy 'apples', Group C- Men- Healthy 'apples'

Primary outcome

Epigenetic marks in abdominal vs gluteal subcutaneous adipose tissue and adipocytes
Time frame: 6 weeks
The preadipocytes obtained from biopsies of Abdominal Fat and Gluteofemoral Fat from patients in the 'pears' woman, 'apple' women and men will be cultured by our standard methods in proliferative medium followed by our standard protocol for differentiation into mature adipocytes. We propose to evaluate samples from 3 individuals from each Group to identify a large number of differentially regulated regions genome wide. All the data obtained in vitro in culture cells will be compared with the data obtained from RNA and chromatin isolated from the whole tissue Abdominal fat and Gluteofemoral fat biopsies

Results and safety

This study is still under way. Results are not available in the source record yet.

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 27 Mar 2026.
Background: PubMed 24239920Jensen MD, Ryan DH, Apovian CM, Ard JD, Comuzzie AG, Donato KA, Hu FB, Hubbard VS, Jakicic JM, Kushner RF, Loria CM, Millen BE, Nonas CA, Pi-Sunyer FX, Stevens J, Stevens VJ, Wadden TA, Wolfe BM, Yanovski SZ; American College of Cardiology/American Heart Association Task Force on Practice Guidelines; Obesity Society. 2013 AHA/ACC/TOS guideline for the management of overweight and obesity in adults: a report of the American College of Cardiology/American Heart Association Task Force on Practice Guidelines and The Obesity Society. J Am Coll Cardiol. 2014 Jul 1;63(25 Pt B):2985-3023. doi: 10.1016/j.jacc.2013.11.004. Epub 2013 Nov 12. No abstract available.
Background: PubMed 19960394McAllister EJ, Dhurandhar NV, Keith SW, Aronne LJ, Barger J, Baskin M, Benca RM, Biggio J, Boggiano MM, Eisenmann JC, Elobeid M, Fontaine KR, Gluckman P, Hanlon EC, Katzmarzyk P, Pietrobelli A, Redden DT, Ruden DM, Wang C, Waterland RA, Wright SM, Allison DB. Ten putative contributors to the obesity epidemic. Crit Rev Food Sci Nutr. 2009 Nov;49(10):868-913. doi: 10.1080/10408390903372599.
Background: PubMed 25411583Roberson L, Shaharyar S, Aneni E, Freitas W, Blaha M, Agatston A, Blumenthal R, Santos RD, Feiz H, Nasir K, Sposito A. The prevalence of the metabolically healthy obese phenotype in an aging population and its association with subclinical cardiovascular disease: The Brazilian study on healthy aging. Diabetol Metab Syndr. 2014 Nov 7;6(1):121. doi: 10.1186/1758-5996-6-121. eCollection 2014.
Background: PubMed 24400816Roberson LL, Aneni EC, Maziak W, Agatston A, Feldman T, Rouseff M, Tran T, Blaha MJ, Santos RD, Sposito A, Al-Mallah MH, Blankstein R, Budoff MJ, Nasir K. Beyond BMI: The "Metabolically healthy obese" phenotype & its association with clinical/subclinical cardiovascular disease and all-cause mortality -- a systematic review. BMC Public Health. 2014 Jan 8;14:14. doi: 10.1186/1471-2458-14-14.
Background: PubMed 17403720de Koning L, Merchant AT, Pogue J, Anand SS. Waist circumference and waist-to-hip ratio as predictors of cardiovascular events: meta-regression analysis of prospective studies. Eur Heart J. 2007 Apr;28(7):850-6. doi: 10.1093/eurheartj/ehm026. Epub 2007 Apr 2.
Background: PubMed 19724291Qiao Q, Nyamdorj R. Is the association of type II diabetes with waist circumference or waist-to-hip ratio stronger than that with body mass index? Eur J Clin Nutr. 2010 Jan;64(1):30-4. doi: 10.1038/ejcn.2009.93. Epub 2009 Sep 2.
Background: PubMed 16271645Yusuf S, Hawken S, Ounpuu S, Bautista L, Franzosi MG, Commerford P, Lang CC, Rumboldt Z, Onen CL, Lisheng L, Tanomsup S, Wangai P Jr, Razak F, Sharma AM, Anand SS; INTERHEART Study Investigators. Obesity and the risk of myocardial infarction in 27,000 participants from 52 countries: a case-control study. Lancet. 2005 Nov 5;366(9497):1640-9. doi: 10.1016/S0140-6736(05)67663-5.
Background: PubMed 13282851VAGUE J. The degree of masculine differentiation of obesities: a factor determining predisposition to diabetes, atherosclerosis, gout, and uric calculous disease. Am J Clin Nutr. 1956 Jan-Feb;4(1):20-34. doi: 10.1093/ajcn/4.1.20. No abstract available.
Background: PubMed 8681056Vague J. Sexual differentiation. A determinant factor of the forms of obesity. 1947. Obes Res. 1996 Mar;4(2):201-3. doi: 10.1002/j.1550-8528.1996.tb00535.x. No abstract available.
Background: PubMed 18492764Santosa S, Jensen MD. Why are we shaped differently, and why does it matter? Am J Physiol Endocrinol Metab. 2008 Sep;295(3):E531-5. doi: 10.1152/ajpendo.90357.2008. Epub 2008 May 20.
Background: PubMed 25863240Fu J, Hofker M, Wijmenga C. Apple or pear: size and shape matter. Cell Metab. 2015 Apr 7;21(4):507-8. doi: 10.1016/j.cmet.2015.03.016.
Background: PubMed 20065965Manolopoulos KN, Karpe F, Frayn KN. Gluteofemoral body fat as a determinant of metabolic health. Int J Obes (Lond). 2010 Jun;34(6):949-59. doi: 10.1038/ijo.2009.286. Epub 2010 Jan 12.
Individual participant dataSharing planned: No

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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.

Steven R Smith, MD principal investigator

Study Principal Investigator

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

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 6 inclusion and 21 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: under way, not looking for participants, as of the sponsor's last update on 27 Mar 2026. 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 United States. 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?

This study is still under way. Results are not available in the source record yet.

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?

Epigenetic marks in abdominal vs gluteal subcutaneous adipose tissue and adipocytes (time frame: 6 weeks). 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 NCT02728635, which also lists 38 linked publications.

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 27 Mar 2026.