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

The recruitment status of this study is unknown because the information has not been verified recently.
Verified November 2011 by Pennington Biomedical Research Center.
Recruitment status was  Active, not recruiting
Sponsor:
Collaborators:
University of Maryland
University of California, San Diego
Information provided by:
Pennington Biomedical Research Center
ClinicalTrials.gov Identifier:
NCT00704197
First received: June 20, 2008
Last updated: November 28, 2011
Last verified: November 2011

June 20, 2008
November 28, 2011
August 2007
December 2011   (final data collection date for primary outcome measure)
To assess sex differences in adipose tissue gene expression in different fat depots [ Time Frame: baseline ] [ Designated as safety issue: No ]
Same as current
Complete list of historical versions of study NCT00704197 on ClinicalTrials.gov Archive Site
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 ] [ Designated as safety issue: No ]
Same as current
Not Provided
Not Provided
 
"ISIS" Study of Sex Differences in Characteristics of Adiposity and Metabolism
Study of Sex Differences in Characteristics of Adiposity and Metabolism

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.

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.

Observational
Observational Model: Case Control
Time Perspective: Cross-Sectional
Not Provided
Retention:   Samples With DNA
Description:

whole blood, urine, adipose tissue

Non-Probability Sample

Residents of Baton Rouge

  • Obesity
  • Diabetes
Not Provided
Not Provided
Pasarica M, Rood J, Ravussin E, Schwarz JM, Smith SR, Redman LM. Reduced oxygenation in human obese adipose tissue is associated with impaired insulin suppression of lipolysis. J Clin Endocrinol Metab. 2010 Aug;95(8):4052-5. doi: 10.1210/jc.2009-2377. Epub 2010 May 13.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Active, not recruiting
23
December 2011
December 2011   (final data collection date for primary outcome measure)

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.
Both
20 Years to 60 Years
Yes
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00704197
0328-0000
Yes
Steven R Smith, Pennigton Biomedical Research Center
Pennington Biomedical Research Center
  • University of Maryland
  • University of California, San Diego
Principal Investigator: Steven R Smith, M.D. Pennington Biomedical Research Center
Pennington Biomedical Research Center
November 2011

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