Epigenetic Regulation of Human Adipose Tissue Distribution
NCT ID: NCT02728635
Last Updated: 2025-03-13
Study Results
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Basic Information
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ACTIVE_NOT_RECRUITING
NA
27 participants
INTERVENTIONAL
2016-07-31
2025-12-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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NON_RANDOMIZED
SINGLE_GROUP
BASIC_SCIENCE
NONE
Study Groups
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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.
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.
Adipose tissue biopsies
Two biopsies will be performed to collect fat tissue from the abdomen and thigh region.
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.
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.
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.
Adipose tissue biopsies
Two biopsies will be performed to collect fat tissue from the abdomen and thigh region.
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.
Group C- Men- Healthy 'apples'
The group will consist of men with a BMI between 23 and 35 kg/m2.
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.
Adipose tissue biopsies
Two biopsies will be performed to collect fat tissue from the abdomen and thigh region.
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.
Interventions
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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.
Adipose tissue biopsies
Two biopsies will be performed to collect fat tissue from the abdomen and thigh region.
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.
Eligibility Criteria
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Inclusion Criteria
* 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
* 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.
18 Years
45 Years
ALL
Yes
Sponsors
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Sanford-Burnham Medical Research Institute
OTHER
AdventHealth Translational Research Institute
OTHER
Responsible Party
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Principal Investigators
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Steven R Smith, MD
Role: PRINCIPAL_INVESTIGATOR
Study Principal Investigator
Locations
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Translational Research Institute for Metabolism and Diabetes
Orlando, Florida, United States
Countries
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References
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Divoux A, Eroshkin A, Erdos E, Sandor K, Osborne TF, Smith SR. DNA Methylation as a Marker of Body Shape in Premenopausal Women. Front Genet. 2021 Jul 29;12:709342. doi: 10.3389/fgene.2021.709342. eCollection 2021.
Related Links
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Translational Research Institute for Metabolism and Diabetes
Other Identifiers
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TRIMDFH 869496
Identifier Type: -
Identifier Source: org_study_id
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