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"ISIS" Study of Sex Differences in Characteristics of Adiposity and Metabolism (ISIS)

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ClinicalTrials.gov Identifier: NCT00704197
Recruitment Status : Unknown
Verified January 2016 by Steven Smith, Pennington Biomedical Research Center.
Recruitment status was:  Active, not recruiting
First Posted : June 24, 2008
Last Update Posted : January 25, 2016
Information provided by (Responsible Party):

Study Description
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.

Condition or disease
Obesity Diabetes

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.

Study Design

Study Type : Observational
Actual Enrollment : 23 participants
Observational Model: Case Control
Time Perspective: Cross-Sectional
Official Title: Study of Sex Differences in Characteristics of Adiposity and Metabolism
Study Start Date : August 2007
Primary Completion Date : December 2013
Estimated Study Completion Date : August 2016
Groups and Cohorts

Outcome Measures

Primary Outcome Measures :
  1. To assess sex differences in adipose tissue gene expression in different fat depots [ Time Frame: baseline ]

Secondary Outcome Measures :
  1. 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 oxygenation [ Time Frame: baseline ]

Biospecimen Retention:   Samples With DNA
whole blood, urine, adipose tissue

Eligibility Criteria

Information from the National Library of Medicine

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Ages Eligible for Study:   20 Years to 60 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Sampling Method:   Non-Probability Sample
Study Population
Residents of Baton Rouge

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.
Contacts and Locations

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): NCT00704197

United States, Louisiana
Pennington Biomedical Research Center
Baton Rouge, Louisiana, United States, 70808
Sponsors and Collaborators
Pennington Biomedical Research Center
University of Maryland
University of California, San Diego
Principal Investigator: Steven R Smith, M.D. Pennington Biomedical Research Center
More Information

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Steven Smith, Clinical Medical Doctor, Pennington Biomedical Research Center
ClinicalTrials.gov Identifier: NCT00704197     History of Changes
Other Study ID Numbers: PBRC 27010
First Posted: June 24, 2008    Key Record Dates
Last Update Posted: January 25, 2016
Last Verified: January 2016