Obesity Clinical Trial
Official title:
Prevalence and Metabolic Consequences of Relative Growth Hormone Deficiency in Abdominal Obesity
Verified date | August 2011 |
Source | Massachusetts General Hospital |
Contact | n/a |
Is FDA regulated | No |
Health authority | United States: Federal Government |
Study type | Observational |
Obesity is one of the leading causes of cardiovascular-related diseases, including diabetes and heart disease. Obesity, and more specifically abdominal obesity, may cause decreased growth hormone (GH) levels. It is believed that GH deficiency may contribute to increased cardiovascular risk by affecting insulin resistance, inflammatory markers, and blood cholesterol levels. This study will determine the occurrence of GH deficiency in abdominal obesity and whether GH deficiency is associated with increased cardiovascular risk beyond traditional risk factors.
Status | Completed |
Enrollment | 149 |
Est. completion date | May 2011 |
Est. primary completion date | December 2009 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | Both |
Age group | 18 Years to 55 Years |
Eligibility |
Inclusion Criteria for Obesity: - Body mass index (BMI) greater than or equal to 30 kg/m2 - Abdominal obesity, defined as waist circumference greater than or equal to 102 cm in men and greater than or equal to 88 cm in women Inclusion Criteria for Lean Controls: - BMI less than 25 kg/m2 - Waist circumference less than 102 cm in men and less than 88 cm in women Exclusion Criteria for both groups: - Obesity due to known secondary causes - Taking any weight lowering drugs - Previous bariatric surgery - Use of the following compounds within the 3 months prior to study entry: estrogen, progesterone, GH, GHRH, glucocorticoids, megesterol acetate, antidiabetic agents, oral contraceptive pills, or any other hormone or drug known to affect GH levels - Change in lipid lowering or antihypertensive regimen within 3 months prior to study entry - Use of testosterone or hormone replacement therapy - Previously known diabetes mellitus or other severe chronic illness - Hemoglobin less than 11.0 g/dL, creatinine greater than 1.5 mg/dL, or serum glutamic oxaloacetic transaminase (SGOT) greater than 2.5 times the upper limit of normal - Follicle stimulating hormone (FSH) greater than 20 IU/L in women - Positive urine pregnancy test - Prior history of pituitary disease, pituitary surgery, head irradiation, or any other condition known to affect the GH axis |
Observational Model: Case Control, Time Perspective: Cross-Sectional
Country | Name | City | State |
---|---|---|---|
United States | Massachusetts General Hospital | Boston | Massachusetts |
Lead Sponsor | Collaborator |
---|---|
Massachusetts General Hospital | National Heart, Lung, and Blood Institute (NHLBI) |
United States,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Prevalence of growth hormone deficiency | Measured at baseline | No | |
Secondary | Carotid intima-media thickness, visceral adiposity, glucose intolerance, inflammatory markers, mitochondrial function, physical activity and adipocytokines | Measured at baseline | No |
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