Status:
TERMINATED
"ISIS" Study of Sex Differences in Characteristics of Adiposity and Metabolism
Lead Sponsor:
Pennington Biomedical Research Center
Collaborating Sponsors:
University of Maryland
University of California, San Diego
Conditions:
Obesity
Diabetes
Eligibility:
All Genders
20-60 years
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 di...
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 DEX...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
August 1 2007
Trial Type :
OBSERVATIONAL
Allocation :
ACTUAL
End Date :
January 1 2016
Estimated Enrollment :
23 Patients enrolled
Trial Details
Trial ID
NCT00704197
Start Date
August 1 2007
End Date
January 1 2016
Last Update
September 15 2022
Active Locations (1)
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1
Pennington Biomedical Research Center
Baton Rouge, Louisiana, United States, 70808