Growth Hormone Treatment on Phosphocreatine Recovery in Obesity
| Status: | Completed |
|---|---|
| Conditions: | Obesity Weight Loss, Women's Studies |
| Therapuetic Areas: | Endocrinology, Reproductive |
| Healthy: | No |
| Age Range: | Any |
| Updated: | 11/18/2012 |
| Start Date: | September 2011 |
| End Date: | September 2013 |
| Contact: | Hideo Makimura, MD, PhD |
| Email: | hmakimura@partners.org |
| Phone: | 617-726-8277 |
The Effects of Short Term Growth Hormone Treatment on Skeletal Muscle Phosphocreatine Recovery in Obesity
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 increases cardiovascular disease risk in obesity. The investigators
hypothesize that reduced GH contributes to dysfunction of the mitochondria. Therefore, the
investigators hypothesize that treatment of obese subjects with reduced GH secretion with GH
will improve mitochondrial function and that this improvement in mitochondrial function will
contribute, in part, to the effects of GH to improve metabolic parameters in obesity. The
investigators propose to study skeletal muscle mitochondria in obese subjects with reduced
GH secretion using magnetic resonance spectroscopy and muscle biopsies before and after
treatment with GH.
Inclusion Criteria:
1. Men age 18-60 years old
2. BMI ≥ 30 kg/m2
3. Waist circumference ≥ 102 cm
4. Peak GH value of ≤ 4.2 μg/l on standard GHRH-arginine stimulation test
Exclusion Criteria:
1. Obesity due to a known secondary cause (Cushing's syndrome, hypothyroidism, etc) or a
history of gastric bypass procedure.
2. Subjects who have a known history of diabetes, fasting blood sugar >125 mg/dl or
using any anti-diabetic drugs.
3. Use of Aspirin, Clopidogrel (Plavix), Warfarin (Coumadin) or other anti-coagulants
4. Subjects on testosterone, glucocorticoids, anabolic steroids, GHRH, GH or IGF-1
within 3 months of enrollment.
5. Changes in lipid lowering or anti-hypertensive regimen within 3 months of screening
6. History of pituitary tumor, hypopituitarism, pituitary surgery, pituitary/brain
radiation or traumatic brain injury or any other condition known to affect the GH
axis.
7. Severe chronic illness including HIV, active malignancy or history of colon cancer.
8. Hemoglobin < 9.0 g/dL, SGOT > 2.5 x upper limit normal, Creatinine >1.5 mg/dL, or PSA
>5 ng/ml.
9. 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.
10. Any condition judged by the patient's physician to cause this clinical trial to be
detrimental to the patient.
11. Contraindications to MRI scanning.
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