Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu

Epigenetic Regulation of Human Adipose Tissue Distribution (Eiffel 2)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02728635
Recruitment Status : Active, not recruiting
First Posted : April 5, 2016
Last Update Posted : February 15, 2019
Sponsor:
Collaborator:
Sanford-Burnham Medical Research Institute
Information provided by (Responsible Party):
Translational Research Institute for Metabolism and Diabetes, Florida

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).

Condition or disease Intervention/treatment Phase
Obesity Other: Dual-energy X-ray absorptiometry (DEXA)/ Magnetic resonance imaging (MRI) and Magnetic resonance spectroscopy (MRS) Procedure: Adipose tissue biopsies Other: FSIGTT/ RMR Not Applicable

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 27 participants
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Basic Science
Official Title: Epigenetic Regulation of Human Adipose Tissue Distribution
Actual Study Start Date : July 2016
Estimated Primary Completion Date : December 2020
Estimated Study Completion Date : December 2020

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.




Primary Outcome Measures :
  1. 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



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   18 Years to 45 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02728635


Locations
Layout table for location information
United States, Florida
Translational Research Institute for Metabolism and Diabetes
Orlando, Florida, United States, 32804
Sponsors and Collaborators
Translational Research Institute for Metabolism and Diabetes, Florida
Sanford-Burnham Medical Research Institute
Investigators
Layout table for investigator information
Principal Investigator: Steven R Smith, MD Study Principal Investigator

Additional Information:
Publications:

Layout table for additonal information
Responsible Party: Translational Research Institute for Metabolism and Diabetes, Florida
ClinicalTrials.gov Identifier: NCT02728635     History of Changes
Other Study ID Numbers: TRIMDFH 869496
First Posted: April 5, 2016    Key Record Dates
Last Update Posted: February 15, 2019
Last Verified: February 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Keywords provided by Translational Research Institute for Metabolism and Diabetes, Florida:
Adipose tissue, epigenetic, abdominal gluteal fat