Study of Recombinant Human Insulin-Like Growth Factor I in Patients With Severe Insulin Resistance
| Status: | Recruiting |
|---|---|
| Conditions: | Endocrine, Diabetes |
| Therapuetic Areas: | Endocrinology |
| Healthy: | No |
| Age Range: | 14 - 65 |
| Updated: | 3/16/2015 |
| Start Date: | April 1998 |
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.
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.
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.
PROTOCOL ENTRY CRITERIA:
--Disease Characteristics--
- Hematologically proven severe insulin resistance with or without diabetes
- Fasting insulin greater than 40 U/mL
- Post glucose insulin greater than 300 U/mL (unless overt diabetes mellitus is
present)
--Prior/Concurrent Therapy--
Endocrine therapy: No concurrent oral hypoglycemic agents and/or insulin
Other: No concurrent birth control pills
--Patient Characteristics--
- Not pregnant
- Negative pregnancy test
- Effective barrier contraceptive method must be used by fertile patients
- Good health
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