Status:
COMPLETED
Effectiveness of Growth Hormone Releasing Hormone in Reducing Abdominal Fat in People Who Are Obese
Lead Sponsor:
Massachusetts General Hospital
Collaborating Sponsors:
National Heart, Lung, and Blood Institute (NHLBI)
Conditions:
Abdominal Obesity
Growth Hormone Deficiency
Eligibility:
All Genders
18-55 years
Phase:
PHASE2
Brief Summary
Obesity, a condition that occurs when a person has too much body fat, affects about 31% of people in the United States. It is associated with increased risk of diabetes, high blood pressure, high chol...
Detailed Description
Obesity, defined as having a high amount of excess body fat, is one of the most wide-spread health problems of today. A variety of factors can lead to obesity. These factors include physical inactivit...
Eligibility Criteria
Inclusion
- Body mass index (BMI) greater than or equal to 30 kg/m2
- Waist circumference greater than or equal to 102 cm in men and greater than or equal to 88 cm in women
- Relative growth hormone (GH) deficiency, defined as a peak GH value of less than or equal to 8 ng/mL on Arginine-GHRH stimulation test
- Hemoglobin level greater than 12.0 g/dL
- Serum glutamic oxaloacetic transaminase and serum glutamic pyruvic transaminase less than 2.5 times the upper limit of normal
- Creatinine level less than 1.5 mg/dL
- Follicle stimulating hormone less than 20 IU/L in women
- Negative mammogram within 1 year of study entry for women older than 40 years of age
Exclusion
- Obesity due to a known secondary cause (e.g., Cushing's syndrome, hypothyroidism) or a history of gastric bypass procedure
- Known hypersensitivity to GHRH 1-44 (TH9507)
- Known history of diabetes, fasting blood sugar less than 125 mg/dL, or antidiabetic drug use
- Using any weight lowering drugs
- Using estrogen, hormone replacement therapy, oral contraceptives, testosterone, glucocorticoids, anabolic steroids, GHRH, GH, or insulin-like growth factor-1 (IGF-1) within 3 months of study entry
- Changes in lipid lowering or antihypertensive regimen within 3 months of study entry
- Long-term illness, including anemia, chronic kidney disease, and liver disease
- History of cancer (except patients with surgically cured basal cell or squamous cell skin cancers) or history of abnormalities on age appropriate malignancy screen, including mammography, colonoscopy, and prostate exam (or prostate specific antigen greater than 5 ng/mL)
- History of hypopituitarism, pituitary surgery, pituitary/brain radiation, traumatic brain injury, or any other condition known to affect the growth hormone axis
- History of any recent cardiovascular event, including heart attack, stroke, transient ischemic attack, unstable angina pectoris, or oxygen-dependent severe pulmonary disease, within 3 months of study entry
- Clinical depression or other psychiatric illness that will not allow completion of the study as per investigator's judgement
- History of or current eating disorder
- History of recent alcohol or substance abuse (less than 1 year before study entry)
- Positive pregnancy test or breastfeeding females and positive fecal occult blood test
- Women of childbearing potential not currently using nonhormonal birth control methods, including barrier methods (e.g., IUD, condoms, diaphragms) or abstinence
- Currently enrolled in another investigational device or drug trial(s) or has received other investigational agent(s) within 28 days of study entry
- Any condition that would make this clinical trial detrimental to the patient, as judged by the patient's physician
- History of noncompliance with other therapies
- Any condition in which compliance with the study protocol is unlikely
Key Trial Info
Start Date :
July 1 2008
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
January 1 2012
Estimated Enrollment :
60 Patients enrolled
Trial Details
Trial ID
NCT00675506
Start Date
July 1 2008
End Date
January 1 2012
Last Update
December 13 2017
Active Locations (1)
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1
Massachusetts General Hospital
Boston, Massachusetts, United States, 02114