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Growth Hormone Treatment on Phosphocreatine Recovery in Obesity

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ClinicalTrials.gov Identifier: NCT01421589
Recruitment Status : Completed
First Posted : August 23, 2011
Results First Posted : July 1, 2014
Last Update Posted : July 1, 2014
Sponsor:
Collaborator:
Pfizer
Information provided by (Responsible Party):
Hideo Makimura, Massachusetts General Hospital

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.

Condition or disease Intervention/treatment Phase
Obese Growth Hormone Secretion Abnormality Drug: Growth hormone treatment Not Applicable

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 15 participants
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: The Effects of Short Term Growth Hormone Treatment on Skeletal Muscle Phosphocreatine Recovery in Obesity
Study Start Date : September 2011
Actual Primary Completion Date : March 2013
Actual Study Completion Date : March 2013

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Hormones
Drug Information available for: Somatropin
U.S. FDA Resources

Arm Intervention/treatment
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.



Primary Outcome Measures :
  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 Outcome Measures :
  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.



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Ages Eligible for Study:   18 Years to 60 Years   (Adult)
Sexes Eligible for Study:   Male
Accepts Healthy Volunteers:   No
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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

Responsible Party: Hideo Makimura, Principal Investigator, Massachusetts General Hospital
ClinicalTrials.gov Identifier: NCT01421589     History of Changes
Other Study ID Numbers: 2011-P-000770
First Posted: August 23, 2011    Key Record Dates
Results First Posted: July 1, 2014
Last Update Posted: July 1, 2014
Last Verified: May 2014

Keywords provided by Hideo Makimura, Massachusetts General Hospital:
Growth hormone
GH
Obesity
Mitochondrial function
reduced growth hormone secretion

Additional relevant MeSH terms:
Obesity
Overnutrition
Nutrition Disorders
Overweight
Body Weight
Signs and Symptoms
Hormones
Phosphocreatine
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs
Cardiotonic Agents
Protective Agents