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Epigenetic Regulation of Human Adipose Tissue Distribution (Eiffel 2)

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ClinicalTrials.gov Identifier: NCT02728635
Recruitment Status : Active, not recruiting
First Posted : April 5, 2016
Last Update Posted : January 13, 2021
Sponsor:
Collaborator:
Sanford-Burnham Medical Research Institute
Information provided by (Responsible Party):
Translational Research Institute for Metabolism and Diabetes, Florida

Tracking Information
First Submitted Date  ICMJE March 24, 2016
First Posted Date  ICMJE April 5, 2016
Last Update Posted Date January 13, 2021
Actual Study Start Date  ICMJE July 2016
Estimated Primary Completion Date June 2021   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: March 30, 2016)
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
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE Not Provided
Original Secondary Outcome Measures  ICMJE Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Epigenetic Regulation of Human Adipose Tissue Distribution
Official Title  ICMJE Epigenetic Regulation of Human Adipose Tissue Distribution
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 Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Basic Science
Condition  ICMJE Obesity
Intervention  ICMJE
  • 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.
Study Arms  ICMJE
  • 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.
    Interventions:
    • Other: Dual-energy X-ray absorptiometry (DEXA)/ Magnetic resonance imaging (MRI) and Magnetic resonance spectroscopy (MRS)
    • Procedure: Adipose tissue biopsies
    • Other: FSIGTT/ RMR
  • 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.
    Interventions:
    • Other: Dual-energy X-ray absorptiometry (DEXA)/ Magnetic resonance imaging (MRI) and Magnetic resonance spectroscopy (MRS)
    • Procedure: Adipose tissue biopsies
    • Other: FSIGTT/ RMR
  • Active Comparator: Group C- Men- Healthy 'apples'
    The group will consist of men with a BMI between 23 and 35 kg/m2.
    Interventions:
    • Other: Dual-energy X-ray absorptiometry (DEXA)/ Magnetic resonance imaging (MRI) and Magnetic resonance spectroscopy (MRS)
    • Procedure: Adipose tissue biopsies
    • Other: FSIGTT/ RMR
Publications *

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Active, not recruiting
Actual Enrollment  ICMJE
 (submitted: March 30, 2016)
27
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE June 2021
Estimated Primary Completion Date June 2021   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 45 Years   (Adult)
Accepts Healthy Volunteers  ICMJE Yes
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT02728635
Other Study ID Numbers  ICMJE TRIMDFH 869496
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Responsible Party Translational Research Institute for Metabolism and Diabetes, Florida
Study Sponsor  ICMJE Translational Research Institute for Metabolism and Diabetes, Florida
Collaborators  ICMJE Sanford-Burnham Medical Research Institute
Investigators  ICMJE
Principal Investigator: Steven R Smith, MD Study Principal Investigator
PRS Account Translational Research Institute for Metabolism and Diabetes, Florida
Verification Date January 2021

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP