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Main
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Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
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Register:
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ClinicalTrials.gov |
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Last refreshed on:
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16 December 2017 |
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Main ID: |
NCT00675506 |
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Date of registration:
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07/05/2008 |
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Prospective Registration:
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Yes |
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Primary sponsor: |
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Public title:
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Effectiveness of Growth Hormone Releasing Hormone in Reducing Abdominal Fat in People Who Are Obese
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Scientific title:
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Physiologic Effects of Long-Term GHRH1-44 in Abdominal Obesity |
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Date of first enrolment:
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July 2008 |
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Target sample size:
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60 |
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Recruitment status: |
Completed |
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URL:
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https://clinicaltrials.gov/show/NCT00675506 |
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Study type:
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Interventional |
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Study design:
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Allocation: Randomized. Intervention model: Parallel Assignment. Primary purpose: Treatment. Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor).
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Phase:
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Phase 2
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Countries of recruitment
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United States
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Contacts
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Name:
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Steven K. Grinspoon, MD |
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Address:
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Telephone:
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Email:
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Affiliation:
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Massachusetts General Hospital |
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Key inclusion & exclusion criteria
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Inclusion Criteria:
- 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 Criteria:
- 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
Age minimum:
18 Years
Age maximum:
55 Years
Gender:
All
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Health Condition(s) or Problem(s) studied
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Growth Hormone Deficiency
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Abdominal Obesity
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Intervention(s)
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Drug: Placebo
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Drug: Growth hormone releasing hormone (GHRH) 1-44
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Primary Outcome(s)
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Change in Visceral Adipose Tissue Volume
[Time Frame: Measured at baseline and Months 6 and 12]
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Secondary Outcome(s)
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Change in Glucose Tolerance as Measured by Oral Glucose Tolerance Test
[Time Frame: Measured at baseline and Months 6 and 12]
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Mitochondrial Function (Post-exercise Phosphocreatine Recovery [ViPCr]) by 31P-MRS
[Time Frame: Measured at Baseline and Month 12]
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Change in Carotid Intima-media Thickness
[Time Frame: Measured at baseline and Months 6 and 12]
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Change in Growth Hormone Pulse Characteristics (Median Pulse Mass) as Assessed by Overnight Frequent Sampling of Growth Hormone
[Time Frame: Measured at baseline and Month 12]
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Change in Lipid Profile (Total Cholesterol, High-density Lipoproteins [HDL] Cholesterol, Low-density Lipoproteins [LDL] Cholesterol, Triglycerides)
[Time Frame: Measured at baseline and Months 6 and 12]
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Secondary ID(s)
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1R01HL085268-01A1
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574
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Source(s) of Monetary Support
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Please refer to primary and secondary sponsors
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