Status:
COMPLETED
Growth Hormone, Cardiovascular Risk, and Visceral Adiposity
Lead Sponsor:
Massachusetts General Hospital
Conditions:
Obesity
Eligibility:
All Genders
18-45 years
Phase:
NA
Brief Summary
This study will compare growth hormone levels and cardiovascular risk markers in normal weight and overweight women and men. In women and men with increased abdominal weight, growth hormone (GH) versu...
Detailed Description
The purpose of this study is to measure growth hormone levels in women and men who are normal weight, overweight, and obese. Growth hormone levels will be correlated with body weight, body composition...
Eligibility Criteria
Inclusion
- For growth hormone measurement part (for men and women):
- For visceral adiposity arm: waist circumference greater than or equal to 88 cm for women or 102 cm for men, and BMI greater than or equal to 25 kg/m2
- For lean controls: BMI 18.5 to 24.9 kg/m2
- For growth hormone treatment part (for men and women):
- Visceral adiposity (waist circumference greater than or equal to 88 cm for women and 102 for men, BMI greater than or equal to 25 kg/m2)
- IGF-I within the lowest 2 quartiles for age and gender
- Willingness to maintain current activity level and diet
Exclusion
- Diabetes mellitus (fasting plasma glucose greater than 126 mg/dL or 2-hour post-oral glucose tolerance test \[OGTT\] plasma glucose greater than 200)
- Taking the following medications in the last 3 months: weight loss or lipid-lowering agents, medications to treat diabetes mellitus or "pre-diabetes", oral contraceptives or estrogen-containing medications, other medications known to significantly affect weight
- Smoking
- Hematocrit below the lower limit of normal
- Amenorrhea for 3 months (in women)
- Pregnant or breastfeeding (in women)
- Polycystic ovary syndrome (in women)
- Weight that exceeds 280 pounds
- SGPT greater than 2 times the upper limit of normal
- History of malignancy, except for fully resolved basal cell carcinomas of the skin (Specific Aim 2 only)
- Radiation exposure greater than 1000 mrem over the last 12 months
- Previous diagnosis of cardiovascular disease
- History of pituitary or hypothalamic disease, brain radiation, or childhood growth hormone deficiency
- History of carpal tunnel syndrome that has not been surgically treated
Key Trial Info
Start Date :
November 1 2004
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
June 1 2013
Estimated Enrollment :
142 Patients enrolled
Trial Details
Trial ID
NCT00131378
Start Date
November 1 2004
End Date
June 1 2013
Last Update
March 11 2016
Active Locations (1)
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1
Massachusetts General Hospital
Boston, Massachusetts, United States, 02114