Epigenetic Regulation of Human Adipose Tissue Distribution

Not Applicable

Active, not recruiting

• Conditions: Obesity
• Interventions: Other: Dual-energy X-ray absorptiometry (DEXA)/ Magnetic resonance imaging (MRI) and Magnetic resonance spectroscopy (MRS); Procedure: Adipose tissue biopsies; Other: FSIGTT/ RMR

• Registration Number: NCT02728635
• Lead Sponsor: AdventHealth Translational Research Institute

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).

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2016-03-24
• Study First Submitted QC: 2016-03-30
• Study First Posted: 2016-04-05
• Study Start: 2016-07
• Primary Completion: 2018-07-11
• Status Verified: 2025-03
• Last Update Submitted: 2025-03-12
• Last Update Posted: 2025-03-13
• Study Completion: 2025-12

Recruitment & Eligibility

• Status: ACTIVE_NOT_RECRUITING
• Sex: All
• Target Recruitment: 27

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Group A- Women- Healthy 'pears'	Dual-energy X-ray absorptiometry (DEXA)/ Magnetic resonance imaging (MRI) and Magnetic resonance spectroscopy (MRS)	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.
Group B- Women- Healthy 'apples'	Adipose tissue biopsies	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.
Group C- Men- Healthy 'apples'	FSIGTT/ RMR	The group will consist of men with a BMI between 23 and 35 kg/m2.
Group B- Women- Healthy 'apples'	FSIGTT/ RMR	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.
Group C- Men- Healthy 'apples'	Dual-energy X-ray absorptiometry (DEXA)/ Magnetic resonance imaging (MRI) and Magnetic resonance spectroscopy (MRS)	The group will consist of men with a BMI between 23 and 35 kg/m2.
Group A- Women- Healthy 'pears'	Adipose tissue biopsies	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.
Group A- Women- Healthy 'pears'	FSIGTT/ RMR	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.
Group B- Women- Healthy 'apples'	Dual-energy X-ray absorptiometry (DEXA)/ Magnetic resonance imaging (MRI) and Magnetic resonance spectroscopy (MRS)	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.
Group C- Men- Healthy 'apples'	Adipose tissue biopsies	The group will consist of men with a BMI between 23 and 35 kg/m2.

Primary Outcome Measures

Name	Time	Method
Epigenetic marks in abdominal vs gluteal subcutaneous adipose tissue and adipocytes	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

Trial Locations

Locations (1)

Translational Research Institute for Metabolism and Diabetes; 🇺🇸 Orlando, Florida, United States