Insulin Resistance Clinical Trial
OBJECTIVES: I. Determine the efficacy and toxic effects of recombinant human insulin-like
growth factor I (rhIGF-I) on carbohydrate tolerance, insulin action, insulin secretion,
hyperandrogenism, and hyperlipidemia in patients with severe insulin resistance who have
failed other therapies.
II. Determine the dose and time response of rhIGF-I on carbohydrate homeostasis and
secondary abnormalities in this patient population.
III. Determine the effect of rhIGF-I on insulin clearance, the regulation of insulin-like
growth factor binding protein 1, the regulation of sex hormone binding globulin, and
hypothalamic pituitary gonadal axis in this patient population.
PROTOCOL OUTLINE: This is an open label study. Patients receive the first dose of
subcutaneous recombinant human insulin-like growth factor I (rhIGF-I) on day 7.
Patients receive rhIGF-I twice daily 15-30 minutes before breakfast and dinner, and are
hospitalized for the first week of therapy. Patients return for an outpatient exam on day 19
of rhIGF-I therapy. Approximately 30 days into the therapy, patients are readmitted to the
clinical center for repeat screening tests. Patients then receive maintenance therapy of
rhIGF-I for up to 6-12 months. A washout period follows the maintenance therapy phase.
Patients are followed weekly, biweekly, or monthly depending on blood glucose response of
patients off rhIGF-I therapy. Weekly phone contact with study coordinator is mandatory
during this time.
Completion date provided represents the completion date of the grant per OOPD records
;
Masking: Open Label, Primary Purpose: Treatment
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