Clinical trial NCT01421589: Growth Hormone Treatment on Phosphocreatine Recovery in Obesity
Official title: The Effects of Short Term Growth Hormone Treatment on Skeletal Muscle Phosphocreatine Recovery in Obesity
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Obese
Growth Hormone Secretion Abnormality
Keywords: Growth hormone
GH
Obesity
Mitochondrial function
reduced growth hormone secretion
Lead sponsor: Massachusetts General Hospital
Sponsor class: OTHER
Collaborators: name: Pfizer
First posted: 2011-08-23
Enrollment: 15
Sex: MALE
Minimum age (years): 18
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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 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.


Eligibility criteria: 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.

Primary outcomes:
measure: Phosphocreatine Recovery
timeFrame: 12-weeks
Secondary outcomes:
measure: Change in Circulating IGF-1 Concentration
timeFrame: Baseline and 12-weeks
measure: Change in Skeletal Muscle IGF-1 Gene Expression
timeFrame: Baseline and 12-weeks
measure: Change in Body Composition
timeFrame: Baseline and 12-weeks
measure: Change in Inflammatory Marker
timeFrame: Baseline and 12-weeks
measure: Change in Insulin Sensitivity
timeFrame: Baseline and 12-weeks
measure: Change in Phosphocreatine Recovery
timeFrame: Baseline and 12-weeks
Other outcomes:
Locations:
city: Boston
country: United States
facility: Massachusetts General Hospital
state: Massachusetts
Study officials:
affiliation: Massachusetts General Hospital
name: Hideo Makimura, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References: