Epigenetic Regulation of Human Adipose Tissue Distribution (Eiffel 2)

July 21, 2023 updated by: AdventHealth Translational Research Institute
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 Overview

Status

Active, not recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

27

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Florida
      • Orlando, Florida, United States, 32804
        • Translational Research Institute for Metabolism and Diabetes

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 45 years (Adult)

Accepts Healthy Volunteers

Yes

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Basic Science
  • Allocation: Non-Randomized
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: Group A- Women- Healthy 'pears'
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.
Other: 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.
Procedure: Adipose tissue biopsies
Two biopsies will be performed to collect fat tissue from the abdomen and thigh region.
Other: FSIGTT/ 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.
Active Comparator: Group B- Women- Healthy 'apples'
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.
Other: 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.
Procedure: Adipose tissue biopsies
Two biopsies will be performed to collect fat tissue from the abdomen and thigh region.
Other: FSIGTT/ 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.
Active Comparator: Group C- Men- Healthy 'apples'
The group will consist of men with a BMI between 23 and 35 kg/m2.
Other: 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.
Procedure: Adipose tissue biopsies
Two biopsies will be performed to collect fat tissue from the abdomen and thigh region.
Other: FSIGTT/ 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
6 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

AdventHealth Translational Research Institute

Collaborators

Sanford-Burnham Medical Research Institute

Investigators

  • Principal Investigator: Steven R Smith, MD, Study Principal Investigator

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

July 1, 2016

Primary Completion (Estimated)

December 1, 2023

Study Completion (Estimated)

December 1, 2023

Study Registration Dates

First Submitted

March 24, 2016

First Submitted That Met QC Criteria

March 30, 2016

First Posted (Estimated)

April 5, 2016

Study Record Updates

Last Update Posted (Estimated)

July 24, 2023

Last Update Submitted That Met QC Criteria

July 21, 2023

Last Verified

July 1, 2023

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • TRIMDFH 869496

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Obesity

Clinical Trials on Dual-energy X-ray absorptiometry (DEXA)/ Magnetic resonance imaging (MRI) and Magnetic resonance spectroscopy (MRS)

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Sweden

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

3
Subscribe