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Epigenetic Regulation of Human Adipose Tissue Distribution

Epigenetic Regulation of Human Adipose Tissue Distribution

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT02728635
Acronym
Eiffel 2
Enrollment
27
Registered
2016-04-05
Start date
2016-07-01
Completion date
2026-12-01
Last updated
2026-03-27

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Obesity

Keywords

Adipose tissue, epigenetic, abdominal gluteal fat

Brief 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).

Interventions

OTHERDual-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.

Two biopsies will be performed to collect fat tissue from the abdomen and thigh region.

OTHERFSIGTT/ RMR

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.

Sponsors

AdventHealth Translational Research Institute
Lead SponsorOTHER
Sanford-Burnham Medical Research Institute
CollaboratorOTHER

Study design

Allocation
NON_RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
BASIC_SCIENCE
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
18 Years to 45 Years
Healthy volunteers
Yes

Inclusion criteria

* 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.

Exclusion criteria

* 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. * 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.

Design outcomes

Primary

MeasureTime frameDescription
Epigenetic marks in abdominal vs gluteal subcutaneous adipose tissue and adipocytes6 weeksThe 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

Countries

United States

Contacts

PRINCIPAL_INVESTIGATORSteven R Smith, MD

Study Principal Investigator

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Mar 28, 2026