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

This study is ongoing, but not recruiting participants.
Sponsor:
Collaborators:
University of Maryland
University of California, San Diego
Information provided by (Responsible Party):
Pennington Biomedical Research Center
ClinicalTrials.gov Identifier:
NCT00704197
First received: June 20, 2008
Last updated: August 11, 2014
Last verified: August 2014
  Purpose

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
Obesity
Diabetes

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

Resource links provided by NLM:


Further study details as provided by Pennington Biomedical Research Center:

Primary Outcome Measures:
  • To assess sex differences in adipose tissue gene expression in different fat depots [ Time Frame: baseline ] [ Designated as safety issue: No ]

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 ] [ Designated as safety issue: No ]

Biospecimen Retention:   Samples With DNA

whole blood, urine, adipose tissue


Enrollment: 23
Study Start Date: August 2007
Estimated Study Completion Date: December 2014
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.

  Eligibility

Ages Eligible for Study:   20 Years to 60 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Sampling Method:   Non-Probability Sample
Study Population

Residents of Baton Rouge

Criteria

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 ClinicalTrials.gov identifier: NCT00704197

Locations
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
Investigators
Principal Investigator: Steven R Smith, M.D. Pennington Biomedical Research Center
  More Information

No publications provided by Pennington Biomedical Research Center

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Pennington Biomedical Research Center
ClinicalTrials.gov Identifier: NCT00704197     History of Changes
Other Study ID Numbers: 0328-0000 (27010)
Study First Received: June 20, 2008
Last Updated: August 11, 2014
Health Authority: United States: Institutional Review Board

ClinicalTrials.gov processed this record on November 25, 2014