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ISIS Study of Sex Differences in Characteristics of Adiposity and Metabolism

Study of Sex Differences in Characteristics of Adiposity and Metabolism

Status
Terminated
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT00704197
Acronym
ISIS
Enrollment
23
Registered
2008-06-24
Start date
2007-08-31
Completion date
2016-01-31
Last updated
2022-09-15

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Diabetes, Obesity

Brief summary

The purpose of this study is to characterize differences in the structure and function of the body fat from two different parts of the body in young, healthy men and women. We will also compare how differences in metabolism relate to characteristics of body fat and its functions.

Detailed description

Following screening, the study comprises of a total of 3 clinic visits (2 outpatient visits, and 1 overnight stay) completed during a 2 week period. For the outpatient visits, body composition (by DEXA), visceral fat (by CT), ectopic fat (by MRS and CT) and aerobic fitness (by VO2max test) will be measured. Women will also have ovarian parameters (follicle size and number) measured during the MR scans. Following an overnight stay in the inpatient unit, insulin sensitivity (by euglycemic hyperinsulinemic clamp), interstitial lipolysis (by microdialysis), whole body lipolysis and glycolysis (by stable isotopes), abdominal adipose tissue oxygen content (Hunt and Direct Methods) will be measured and a subcutaneous fat biopsy of the abdominal and gluteo-femoral tissue will be collected. Women will complete all testing in the follicular phase of the menstrual cycle.

Interventions

None listed

Sponsors

University of Maryland
CollaboratorOTHER
University of California, San Diego
CollaboratorOTHER
Pennington Biomedical Research Center
Lead SponsorOTHER

Study design

Observational model
CASE_CONTROL
Time perspective
CROSS_SECTIONAL

Eligibility

Sex/Gender
ALL
Age
20 Years to 60 Years
Healthy volunteers
Yes

Inclusion criteria

* Diabetic men and women ages 40 to 60, inclusive and healthy men and women ages 20 to 35, inclusive. * Body mass index (a ratio of height to weight) less than 25 kg/m2 (lean group) or 27 to 35 kg/m2 (overweight/obese group). * Not involved in regular physical activity (more than 3 times per week). * Women must have regular menstrual cycles (1 menstrual bleeding each month).

Exclusion criteria

* For men in the overweight/obese group, you have a waist circumference less than 102cm (40 inches). * You smoke. * You have liver, kidney, thyroid or heart diseases, or cancer. * You are claustrophobic. * You have metal objects in your body such as implanted rods or surgical clips. * If you are not diabetic and you are taking steroids, protease inhibitors, statins, antihypertensives or medications known to alter glucose or lipid metabolism. * If you are diabetic and you are taking steroids, protease inhibitors, or injectable antihyperglycemic medications (oral diabetic meds are allowed.) * If you are a woman, you are pregnant or breast feeding or trying to become pregnant (women who become pregnant throughout the study will be excluded). * If you are a woman, you are using hormonal contraceptives or have anovulation, androgen excess or irregular menstrual cycles (less than 1 cycle per month). * You have previously had a BMI \>35 kg/m2. * You are not able to eat the foods provided by PBRC. * If your weight has not been stable.

Design outcomes

Primary

MeasureTime frame
To assess sex differences in adipose tissue gene expression in different fat depotsbaseline

Secondary

MeasureTime frame
To assess sex differences in other characteristics of adipose tissue structure and function in different fat depots across sex including: preadipocyte kinetics; lipolysis and lipogenesis; macrophage content; and tissue oxygenationbaseline

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 25, 2026