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Growth Hormone Treatment on Phosphocreatine Recovery in Obesity

Information source: Massachusetts General Hospital
ClinicalTrials.gov processed this data on August 23, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Obese; Growth Hormone Secretion Abnormality

Intervention: Growth hormone treatment (Drug)

Phase: N/A

Status: Completed

Sponsored by: Massachusetts General Hospital

Official(s) and/or principal investigator(s):
Hideo Makimura, MD, PhD, Principal Investigator, Affiliation: Massachusetts General Hospital


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.

Clinical Details

Official title: The Effects of Short Term Growth Hormone Treatment on Skeletal Muscle Phosphocreatine Recovery in Obesity

Study design: Allocation: Non-Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Primary outcome: Phosphocreatine Recovery

Secondary outcome:

Change in Circulating IGF-1 Concentration

Change in Skeletal Muscle IGF-1 Gene Expression

Change in Body Composition

Change in Inflammatory Marker

Change in Insulin Sensitivity

Change in Phosphocreatine Recovery


Minimum age: 18 Years. Maximum age: 60 Years. Gender(s): Male.


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.

Locations and Contacts

Massachusetts General Hospital, Boston, Massachusetts 02114, United States
Additional Information

Starting date: September 2011
Last updated: May 29, 2014

Page last updated: August 23, 2015

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