Study of Recombinant Human Insulin-Like Growth Factor I in Patients With Severe Insulin Resistance

• Status: Completed
• Trial end date: 2000-09-01
• Target enrollment: 0
• Participant gender: All

Summary

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.

• Phase: N/A
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Beth Israel Deaconess Medical Center
• Treatments: Complement Factor I; Insulin; Insulin, Globin Zinc; Mitogens

Criteria

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