Obese Clinical Trial
Official title:
The Effects of Short Term Growth Hormone Treatment on Skeletal Muscle Phosphocreatine Recovery in Obesity
Verified date | May 2014 |
Source | Massachusetts General Hospital |
Contact | n/a |
Is FDA regulated | No |
Health authority | United States: Institutional Review Board |
Study type | Interventional |
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.
Status | Completed |
Enrollment | 15 |
Est. completion date | March 2013 |
Est. primary completion date | March 2013 |
Accepts healthy volunteers | No |
Gender | Male |
Age group | 18 Years to 60 Years |
Eligibility |
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. |
Allocation: Non-Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Country | Name | City | State |
---|---|---|---|
United States | Massachusetts General Hospital | Boston | Massachusetts |
Lead Sponsor | Collaborator |
---|---|
Massachusetts General Hospital | Pfizer |
United States,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Phosphocreatine Recovery | 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. | 12-weeks | No |
Secondary | Change in Circulating IGF-1 Concentration | Change in circulating IGF-1 from Baseline to 12-weeks is reported. | Baseline and 12-weeks | No |
Secondary | Change in Skeletal Muscle IGF-1 Gene Expression | Change in skeletal muscle IGF-1 gene mRNA expression from Baseline to 12-weeks is reported. | Baseline and 12-weeks | No |
Secondary | Change in Body Composition | Change in waist circumference from Baseline to 12-weeks is reported. | Baseline and 12-weeks | No |
Secondary | Change in Inflammatory Marker | Change in high sensitivity C-reactive protein (hsCRP) from Baseline to 12-weeks is reported. | Baseline and 12-weeks | No |
Secondary | Change in Insulin Sensitivity | Change in fasting glucose from Baseline to 12-weeks is reported. | Baseline and 12-weeks | Yes |
Secondary | Change in Phosphocreatine Recovery | Change in phosphocreatine recovery, represented by ViPCr, from Baseline to 12-weeks is reported. | Baseline and 12-weeks | No |
Status | Clinical Trial | Phase | |
---|---|---|---|
Completed |
NCT04105075 -
COPD in Obese Patients
|
||
Completed |
NCT04099654 -
The Effect of Core Stabilization Exercise Program in Obese Subjects Awaiting Bariatric Surgery
|
N/A | |
Recruiting |
NCT05857150 -
Exercise Response in Humans With Obesity
|
||
Completed |
NCT03532672 -
Early Effect of Fasting on Metabolic, Inflammatory, and Behavioral Responses in Females With and Without Obesity
|
N/A | |
Completed |
NCT02086448 -
Sleep Disordered Breathing, Obesity and Pregnancy Study (SOAP)
|
N/A | |
Completed |
NCT02618486 -
The Effects of Obesity on Non Surgical Periodontal Therapy
|
N/A | |
Completed |
NCT01724515 -
PGC-1 and Mitochondrial Dysfunction in Diabetes
|
N/A | |
Completed |
NCT01724502 -
Mitochondrial Dysfunction in Diabetes
|
N/A | |
Active, not recruiting |
NCT01634204 -
Efficacy of a Web-based Weight Loss Program
|
Phase 2 | |
Completed |
NCT01479933 -
Glucose Metabolism Effects of Vitamin D Supplementation in Prediabetes
|
N/A | |
Completed |
NCT01467817 -
Obesity/Overweight in Persons With Early and Chronic Spinal Cord Injury (SCI)
|
N/A | |
Completed |
NCT03528304 -
Native Women's Wellness: Contingency Management for Tobacco Cessation and Weight Loss
|
N/A | |
Completed |
NCT01726647 -
Metabolism Associated With Abdominal Fat Mass Distribution
|
N/A | |
Active, not recruiting |
NCT02125149 -
The Expecting Study
|
N/A | |
Completed |
NCT05737927 -
Pharmacodynamics and Pharmacokinetics of Different Glucose Bead Formulations in Obese Healthy Subjects
|
Phase 1 | |
Completed |
NCT05433506 -
Safety and Pharmacokinetics of HU6
|
Phase 1 | |
Completed |
NCT02871882 -
Ox Bile- Conjugated Bile Acids Sodium in Type II Diabetes Mellitus
|
Phase 2 | |
Completed |
NCT03298464 -
Study of NGM313 in Obese Participants
|
Phase 1 | |
Completed |
NCT05061173 -
Comparison of Aerobic, Resistance, and Combined Training in Overweight/Obese Hypertensive Adults
|
N/A | |
Completed |
NCT02919176 -
Brown Fat Activation Study
|
Early Phase 1 |