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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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19 February 2015 |
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Main ID: |
NCT00517062 |
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Date of registration:
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15/08/2007 |
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Prospective Registration:
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No |
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Primary sponsor: |
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Public title:
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Low Dose Growth Hormone (GH) on Insulin Sensitivity and Cortisol Production Rates
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Scientific title:
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Effects of Low Dose Growth Hormone (GH) Therapy on Insulin Sensitivity, Adipocyte Insulin-like Growth Factor-I (IGF-I) and IGF-I/Insulin Receptor Density and Regulation of Cortisol Metabolism in GH Deficient Adults |
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Date of first enrolment:
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January 2006 |
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Target sample size:
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16 |
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Recruitment status: |
Completed |
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URL:
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http://clinicaltrials.gov/show/NCT00517062 |
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Study type:
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Interventional |
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Study design:
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Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment
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Phase:
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Phase 0
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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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Jonathan Q. Purnell, 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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Oregon Health and Science University |
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Name:
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Charles T. Roberts, PhD |
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Address:
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Telephone:
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Email:
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Affiliation:
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Oregon Health and Science University |
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Key inclusion & exclusion criteria
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Inclusion Criteria:
- Age range 18 to 75 years
- BMI should not exceed 40 kg/m2
- Confirmed GH deficient with at least one provocative test, e.g. insulin tolerance
test and/ or GHRH/arginine
- Not received any GH therapy within last 6 months
- On a stable standardized hydrocortisone replacement dose regimen (twice a day at 8 AM
and 4 PM),
- If any other pituitary hormone deficiencies are present, patient must be on optimal
pituitary hormone replacement therapy, e.g. Thyroxine, testosterone and oestrogen
replacement
- Normal renal and hepatic function
- Prepared to self-inject
Exclusion Criteria:
- Untreated or subclinically hypo/hyperthyroid
- Untreated or subclinically treated hypocortisolism
- Type 1 or 2 diabetes mellitus
- Subjects with evidence of nephropathy from any cause
- Subjects with evidence of retinopathy from any cause
- Any other medical illnesses that may affect the interpretation of the results
- Pregnant
- Emotional/social instability likely to prejudice study completion
- Previous history of known malignancy
- Recurrent or severe unexplained hypoglycaemia
- Known or suspected drug/alcohol abuse
Age minimum:
18 Years
Age maximum:
75 Years
Gender:
Both
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Health Condition(s) or Problem(s) studied
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Growth Hormone Deficiency
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Intervention(s)
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Drug: Growth hormone (Genotropin)
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Drug: Placebo
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Primary Outcome(s)
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Changes in insulin sensitivity (from the hyperinsulinemic euglycemic clamp
[Time Frame: 3 months]
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Secondary Outcome(s)
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Changes in fat IGF-I and IGF-I/insulin hybrid receptor density and body composition.
[Time Frame: 3 months]
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Source(s) of Monetary Support
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Please refer to primary and secondary sponsors
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Results
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Results available:
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Date Posted:
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Date Completed:
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URL:
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