Growth Hormone Deficiency Clinical Trial
Official title:
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
Study hypothesis:
Growth hormone (GH), through its generation of free 'bioavailable' insulin-like growth
factor (IGF)-I, can improve insulin sensitivity in adults with GH deficiency.
Study aims:
The purpose of this study is to determine the mechanism of how low dose GH treatment affects
the body's sensitivity to insulin actions and whether this low GH dose can affect the body's
handling of steroid hormone levels (cortisol clearance) in adults with GH deficiency.
Study design:
Men and women with confirmed GH deficiency, but not recently been on GH treatment will be
invited to participate in this study. The subjects will be assessed at the initial visit to
ascertain their suitability before further participating in the study. If suitable, an equal
number of men and women will be randomized to receive either low dose GH or placebo
injection for 3 months. Before, during and after treatment, the subjects will be assessed at
regularly with blood tests, scans and fat biopsies. At the first and final visit, testing
will include scans to measure the amount of whole body fat and fat in the stomach area,
muscle, and liver; blood tests to measure levels of cortisol, and fat tissue (taken from a
biopsy) analysis to measure the density of IGF-I in the muscle; whereas blood tests to
examine insulin sensitivity will also be collected. This study will use Genotropin and
Genotropin pen devices, and the the data will be analyzed using a computer statistical
program where the identity of the subjects will be coded to maintain confidentiality.
Status | Completed |
Enrollment | 16 |
Est. completion date | January 2012 |
Est. primary completion date | January 2012 |
Accepts healthy volunteers | No |
Gender | Both |
Age group | 18 Years to 75 Years |
Eligibility |
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 |
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment
Country | Name | City | State |
---|---|---|---|
United States | Oregon Health and Science University | Portland | Oregon |
Lead Sponsor | Collaborator |
---|---|
Oregon Health and Science University |
United States,
Yuen K, Frystyk J, Umpleby M, Fryklund L, Dunger D. Changes in free rather than total insulin-like growth factor-I enhance insulin sensitivity and suppress endogenous peak growth hormone (GH) release following short-term low-dose GH administration in young healthy adults. J Clin Endocrinol Metab. 2004 Aug;89(8):3956-64. — View Citation
Yuen K, Wareham N, Frystyk J, Hennings S, Mitchell J, Fryklund L, Dunger D. Short-term low-dose growth hormone administration in subjects with impaired glucose tolerance and the metabolic syndrome: effects on beta-cell function and post-load glucose tolerance. Eur J Endocrinol. 2004 Jul;151(1):39-45. — View Citation
Yuen KC, Frystyk J, White DK, Twickler TB, Koppeschaar HP, Harris PE, Fryklund L, Murgatroyd PR, Dunger DB. Improvement in insulin sensitivity without concomitant changes in body composition and cardiovascular risk markers following fixed administration of a very low growth hormone (GH) dose in adults with severe GH deficiency. Clin Endocrinol (Oxf). 2005 Oct;63(4):428-36. Erratum in: Clin Endocrinol (Oxf). 2005 Nov;63(5):599. — View Citation
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Changes in insulin sensitivity (from the hyperinsulinemic euglycemic clamp | 3 months | Yes | |
Secondary | Changes in fat IGF-I and IGF-I/insulin hybrid receptor density and body composition. | 3 months | Yes |
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