Try our beta test site
IMPORTANT: Listing of a study on this site does not reflect endorsement by the National Institutes of Health. Talk with a trusted healthcare professional before volunteering for a study. Read more...

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

This study is ongoing, but not recruiting participants.
University of Maryland
University of California, San Diego
Information provided by (Responsible Party):
Steven Smith, Pennington Biomedical Research Center Identifier:
First received: June 20, 2008
Last updated: January 22, 2016
Last verified: January 2016
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.


Study Type: Observational
Study Design: Observational Model: Case Control
Time Perspective: Cross-Sectional
Official Title: Study of Sex Differences in Characteristics of Adiposity and Metabolism

Further study details as provided by Steven Smith, Pennington Biomedical Research Center:

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

Secondary Outcome Measures:
  • 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

Enrollment: 23
Study Start Date: August 2007
Estimated Study Completion Date: August 2016
Primary Completion Date: December 2013 (Final data collection date for primary outcome measure)
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.

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
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, see Learn About Clinical Studies.

Please refer to this study by its identifier: 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 Identifier (NCT Number):
Responsible Party: Steven Smith, Clinical Medical Doctor, Pennington Biomedical Research Center Identifier: NCT00704197     History of Changes
Other Study ID Numbers: PBRC 27010
Study First Received: June 20, 2008
Last Updated: January 22, 2016 processed this record on May 25, 2017