Low Dose Growth Hormone (GH) on Insulin Sensitivity and Cortisol Production Rates

• Status: Completed
• Trial end date: 2012-01-01
• Target enrollment: 0
• Participant gender: All

Summary

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.

• Phase: Early Phase 1
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Oregon Health and Science University
• Treatments: Cortisol succinate; Hormones; Hydrocortisone; Hydrocortisone 17-butyrate 21-propionate; Hydrocortisone acetate; Insulin; Insulin, Globin Zinc

Criteria

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