Growth Hormone Treatment on Phosphocreatine Recovery in Obesity - Full Text View

Purpose

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.

Condition	Intervention
Obese Growth Hormone Secretion Abnormality	Drug: Growth hormone treatment

Study Type:	Interventional
Study Design:	Allocation: Non-Randomized Endpoint Classification: Efficacy Study Intervention Model: Single Group Assignment Masking: Open Label Primary Purpose: Treatment
Official Title:	The Effects of Short Term Growth Hormone Treatment on Skeletal Muscle Phosphocreatine Recovery in Obesity

Resource links provided by NLM:

Genetics Home Reference related topics: combined pituitary hormone deficiency isolated growth hormone deficiency metatropic dysplasia pseudoachondroplasia

MedlinePlus related topics: Diabetes Medicines Obesity

Drug Information available for: Somatropin

U.S. FDA Resources

Further study details as provided by Massachusetts General Hospital:

Primary Outcome Measures:

Change in Phosphocreatine recovery [ Time Frame: Baseline and 12-weeks ] [ Designated as safety issue: No ]
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.

Secondary Outcome Measures:

Change in skeletal muscle mitochondrial gene expression [ Time Frame: Baseline and 12-weeks ] [ Designated as safety issue: No ]
Change in intramyocellular lipid content [ Time Frame: Baseline and 12-weeks ] [ Designated as safety issue: No ]
Change in body composition [ Time Frame: Baseline and 12-weeks ] [ Designated as safety issue: No ]
Change in lipid profile [ Time Frame: Baseline and 12-weeks ] [ Designated as safety issue: No ]
Change in insulin sensitivity [ Time Frame: Baseline and 12-weeks ] [ Designated as safety issue: Yes ]

Estimated Enrollment:	15
Study Start Date:	September 2011
Estimated Study Completion Date:	September 2013
Estimated Primary Completion Date:	September 2013 (Final data collection date for primary outcome measure)

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

Eligibility

Ages Eligible for Study:	18 Years to 60 Years
Genders Eligible for Study:	Male
Accepts Healthy Volunteers:	No

Criteria

Inclusion Criteria:

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

Exclusion Criteria:

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.

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT01421589

Locations

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

Sponsors and Collaborators

Massachusetts General Hospital

Pfizer

Investigators

Principal Investigator:

Hideo Makimura, MD, PhD

Massachusetts General Hospital

More Information

No publications provided

Responsible Party:	Hideo Makimura, Principal Investigator, Massachusetts General Hospital
ClinicalTrials.gov Identifier:	NCT01421589 History of Changes
Other Study ID Numbers:	2011-P-000770
Study First Received:	August 19, 2011
Last Updated:	January 16, 2013
Health Authority:	United States: Institutional Review Board

Keywords provided by Massachusetts General Hospital:

Growth hormone
GH
Obesity
Mitochondrial function
reduced growth hormone secretion

Additional relevant MeSH terms:

Congenital Abnormalities
Obesity
Dwarfism, Pituitary
Overnutrition
Nutrition Disorders
Overweight
Body Weight
Signs and Symptoms
Dwarfism
Bone Diseases, Developmental
Bone Diseases
Musculoskeletal Diseases
Bone Diseases, Endocrine
Hypopituitarism
Pituitary Diseases

Hypothalamic Diseases
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Endocrine System Diseases
Hormones
Phosphocreatine
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs
Pharmacologic Actions
Cardiotonic Agents
Cardiovascular Agents
Therapeutic Uses
Protective Agents

ClinicalTrials.gov processed this record on May 22, 2013