Growth Hormone Treatment on Phosphocreatine Recovery in Obesity

Obese Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01421589
• Other study ID #: 2011-P-000770
• Status: Completed
• Phase: N/A
• First received: August 19, 2011
• Last updated: May 29, 2014
• Start date: September 2011
• Est. completion date: March 2013

Study information

• Verified date: May 2014
• Source: Massachusetts General Hospital
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 15
• Est. completion date: March 2013
• Est. primary completion date: March 2013
• Accepts healthy volunteers: No
• Gender: Male
• Age group: 18 Years to 60 Years

Eligibility

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.

Study Design

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

Related Conditions & MeSH terms

• Growth Hormone Secretion Abnormality
• Obese

Intervention

Drug:
• Growth hormone treatment
Growth hormone 0.4 mg once daily (titrated to IGF-1) by sub-cutaneous injection for 12 weeks.

Locations

Country	Name	City	State
United States	Massachusetts General Hospital	Boston	Massachusetts

Sponsors (2)

Lead Sponsor	Collaborator
Massachusetts General Hospital	Pfizer

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Phosphocreatine Recovery	The primary objective of this study is to determine the effects of growth hormone on mitochondrial function as assessed by 31P-MRS in obese subjects with reduced GH secretion. Mitochondrial function was represented by ViPCr, a measure of phosphocreatine recovery after sub-maximal exercise. Univariate regression analyses was performed to assess the relationship between the change in skeletal muscle IGF-1 mRNA after 12 weeks treatment with rhGH to change in ViPCr.	12-weeks	No
Secondary	Change in Circulating IGF-1 Concentration	Change in circulating IGF-1 from Baseline to 12-weeks is reported.	Baseline and 12-weeks	No
Secondary	Change in Skeletal Muscle IGF-1 Gene Expression	Change in skeletal muscle IGF-1 gene mRNA expression from Baseline to 12-weeks is reported.	Baseline and 12-weeks	No
Secondary	Change in Body Composition	Change in waist circumference from Baseline to 12-weeks is reported.	Baseline and 12-weeks	No
Secondary	Change in Inflammatory Marker	Change in high sensitivity C-reactive protein (hsCRP) from Baseline to 12-weeks is reported.	Baseline and 12-weeks	No
Secondary	Change in Insulin Sensitivity	Change in fasting glucose from Baseline to 12-weeks is reported.	Baseline and 12-weeks	Yes
Secondary	Change in Phosphocreatine Recovery	Change in phosphocreatine recovery, represented by ViPCr, from Baseline to 12-weeks is reported.	Baseline and 12-weeks	No