Growth Hormone Treatment on Phosphocreatine Recovery in Obesity

NCT01421589 | Completed Results DMC

• 1 other identifier: 2011-P-000770
• Study Type: interventional
• Target: 15
• Locations: 1 country
• Sites: 1

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.

Conditions

Obese; Growth Hormone Secretion Abnormality

Keywords

Growth hormone; GH; Obesity; Mitochondrial function; reduced growth hormone secretion

Outcome Measures

Primary Outcomes (1)

• 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

Secondary Outcomes (6)

• Change in Circulating IGF-1 Concentration

  Baseline and 12-weeks

• Change in Skeletal Muscle IGF-1 Gene Expression

  Baseline and 12-weeks

• Change in Body Composition

  Baseline and 12-weeks

• Change in Inflammatory Marker

  Baseline and 12-weeks

• Change in Insulin Sensitivity

  Baseline and 12-weeks

Study Arms (1)

Growth Hormone

EXPERIMENTAL

Drug: Growth hormone treatment

Interventions

Growth hormone treatment DRUG

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

Growth Hormone

Eligibility Criteria

• Age: 18 Years - 60 Years
• Sex: male
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Massachusetts General Hospital: lead
• Pfizer: collaborator

Study Sites (1)

Massachusetts General Hospital

Boston, Massachusetts, 02114, United States

Location

MeSH Terms

Conditions

Obesity

Condition Hierarchy (Ancestors)

Overweight; Overnutrition; Nutrition Disorders; Nutritional and Metabolic Diseases; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Results Point of Contact

• Title: Hideo Makimura, MD, PhD
• Organization: Massachusetts General Hospital

hmakimura@partners.org

617-726-8277

Study Officials

• Hideo Makimura, MD, PhD

  Massachusetts General Hospital

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: LTE60
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: August 19, 2011
• First Posted: August 23, 2011
• Study Start: September 1, 2011
• Primary Completion: March 1, 2013
• Study Completion: March 1, 2013
• Last Updated: July 1, 2014
• Results First Posted: July 1, 2014

Record last verified: 2014-05

Locations

US (1)