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NCT Number: NCT01421589

Growth Hormone Treatment on Phosphocreatine Recovery in Obesity

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.

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Key information

Conditions

Obese Body Weight Growth Hormone Secretion Abnormality Nutrition Disorders Nutritional and Metabolic Diseases Obesity Overnutrition Overweight Pathological Conditions, Signs and Symptoms Signs and Symptoms

Age range

18 year–60 year

Sex eligibility

Male

Study type

Interventional

Phase

Not applicable

Primary location

Massachusetts General Hospital

Boston, Massachusetts, 02114, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

growth hormone treatment

Drug

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

Primary outcomes

  1. Phosphocreatine Recovery

    Time frame: 12-weeks

    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.

Secondary outcomes

  1. Change in Circulating IGF-1 Concentration

    Time frame: Baseline and 12-weeks

    Change in circulating IGF-1 from Baseline to 12-weeks is reported.

  2. Change in Skeletal Muscle IGF-1 Gene Expression

    Time frame: Baseline and 12-weeks

    Change in skeletal muscle IGF-1 gene mRNA expression from Baseline to 12-weeks is reported.

  3. Change in Body Composition

    Time frame: Baseline and 12-weeks

    Change in waist circumference from Baseline to 12-weeks is reported.

  4. Change in Inflammatory Marker

    Time frame: Baseline and 12-weeks

    Change in high sensitivity C-reactive protein (hsCRP) from Baseline to 12-weeks is reported.

  5. Change in Insulin Sensitivity

    Time frame: Baseline and 12-weeks

    Change in fasting glucose from Baseline to 12-weeks is reported.

  6. Change in Phosphocreatine Recovery

    Time frame: Baseline and 12-weeks

    Change in phosphocreatine recovery, represented by ViPCr, from Baseline to 12-weeks is reported.

Sponsors and collaborators

Lead sponsor

Massachusetts General Hospital

Other

Collaborators

  • Pfizer

Registry information

Official study title

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

Important dates

Study start
2011
Primary completion
2013
Study completion
2013
First posted
Aug 23, 2011
Registry last updated
Jul 1, 2014

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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