Status:
COMPLETED
Growth Hormone Treatment on Phosphocreatine Recovery in Obesity
Lead Sponsor:
Massachusetts General Hospital
Collaborating Sponsors:
Pfizer
Conditions:
Obese
Growth Hormone Secretion Abnormality
Eligibility:
MALE
18-60 years
Phase:
NA
Brief Summary
Obesity is associated with reduced growth hormone (GH) secretion. Reduced GH secretion in obesity is associated with increased cardiovascular disease risk. However, it is not yet known how reduced GH ...
Eligibility Criteria
Inclusion
- Men age 18-60 years old
- BMI ≥ 30 kg/m2
- Waist circumference ≥ 102 cm
- Peak GH value of ≤ 4.2 μg/l on standard GHRH-arginine stimulation test
Exclusion
- Obesity due to a known secondary cause (Cushing's syndrome, hypothyroidism, etc) or a history of gastric bypass procedure.
- Subjects who have a known history of diabetes, fasting blood sugar \>125 mg/dl or using any anti-diabetic drugs.
- Use of Aspirin, Clopidogrel (Plavix), Warfarin (Coumadin) or other anti-coagulants
- Subjects on testosterone, glucocorticoids, anabolic steroids, GHRH, GH or IGF-1 within 3 months of enrollment.
- Changes in lipid lowering or anti-hypertensive regimen within 3 months of screening
- History of pituitary tumor, hypopituitarism, pituitary surgery, pituitary/brain radiation or traumatic brain injury or any other condition known to affect the GH axis.
- Severe chronic illness including HIV, active malignancy or history of colon cancer.
- Hemoglobin \< 9.0 g/dL, SGOT \> 2.5 x upper limit normal, Creatinine \>1.5 mg/dL, or PSA \>5 ng/ml.
- Subject is currently enrolled in another investigational device or drug trial(s), or subject has received other investigational agent(s) within 28 days of baseline visit.
- Any condition judged by the patient's physician to cause this clinical trial to be detrimental to the patient.
- Contraindications to MRI scanning.
Key Trial Info
Start Date :
September 1 2011
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
March 1 2013
Estimated Enrollment :
15 Patients enrolled
Trial Details
Trial ID
NCT01421589
Start Date
September 1 2011
End Date
March 1 2013
Last Update
July 1 2014
Active Locations (1)
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1
Massachusetts General Hospital
Boston, Massachusetts, United States, 02114