Growth Hormone Treatment on Phosphocreatine Recovery in Obesity
NCT01421589
ABOUT THIS STUDY
FOR MORE INFORMATION
Contact a representative by phone, email, or visiting the study website. Please see the references below:
Pfizer Clinical Trials Contact Center
1-800-718-1021
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
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.
NEED INFO?
Questions about a trial? Call or email to reach a Pfizer Clinical Trial Contact Center Representative

TRY A NEW SEARCH
Search for Clinical Trials by condition, keyword or trial number. Share your location or enter your city or zip code to find studies near you.
Based on your search, you may also be interested in
- Boston, Massachusetts
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 |
| |||
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 | 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:
Exclusion Criteria:
| |||
Sex/Gender ICMJE |
| |||
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 |
| |||
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 |