Growth Hormone Treatment on Phosphocreatine Recovery in Obesity

NCT01421589

Last updated date
Study Location
Massachusetts General Hospital
Boston, Massachusetts, 02114, United States
Contact
1-800-718-1021

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Eligibility Criteria
condition
The disease, disorder, syndrome, illness, or injury that is being studied.
Obese, Growth Hormone Secretion Abnormality
Sex
Male
Age
Pediatric Trials: 0-17 Years
Adult Trials: 18+ Years
18-60 years
Inclusion Criteria
The factors, or reasons, that allow a person to participate in a clinical study.
Show details

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
The factors, or reasons, that prevent a person from participating in a clinical study.
Show details


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.

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Obese, Growth Hormone Secretion AbnormalityGrowth Hormone Treatment on Phosphocreatine Recovery in Obesity
NCT01421589
  1. Boston, Massachusetts
Male
18 Years+
years
MULTIPLE SITES
Advanced Information
Descriptive Information
Brief Title  ICMJE Growth Hormone Treatment on Phosphocreatine Recovery in Obesity
Official Title  ICMJE The Effects of Short Term Growth Hormone Treatment on Skeletal Muscle Phosphocreatine Recovery in Obesity
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.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE
  • Obese
  • Growth Hormone Secretion Abnormality
Intervention  ICMJE Drug: Growth hormone treatment
Growth hormone 0.4 mg once daily (titrated to IGF-1) by sub-cutaneous injection for 12 weeks.
Study Arms  ICMJE Experimental: Growth Hormone
Intervention: Drug: Growth hormone treatment
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: August 22, 2011)
15
Original Estimated Enrollment  ICMJE Same as current
Actual Study Completion Date  ICMJE March 2013
Actual Primary Completion Date March 2013   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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 ?g/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.
Sex/Gender  ICMJE
Sexes Eligible for Study:Male
Ages  ICMJE 18 Years to 60 Years   (Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT01421589
Other Study ID Numbers  ICMJE 2011-P-000770
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Hideo Makimura, Massachusetts General Hospital
Study Sponsor  ICMJE Massachusetts General Hospital
Collaborators  ICMJE Pfizer
Investigators  ICMJE
Principal Investigator:Hideo Makimura, MD, PhDMassachusetts General Hospital
PRS Account Massachusetts General Hospital
Verification Date May 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP