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.

Condition	Treatment or Intervention
Insulin Resistance Hyperglycemia	Drug: insulin-like growth factor I

Further Study Details: 

Expected Total Enrollment:  18

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.

Ages Eligible for Study:  14 Years   -   65 Years,  Genders Eligible for Study:  Both

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

Massachusetts
      Beth Israel Deaconess Medical Center, Boston,  Massachusetts,  02215,  United States; Recruiting

Study chairs or principal investigators

Alan C. Moses,  Study Chair,  Beth Israel Deaconess Medical Center   

Study ID Numbers:  199/13313; BIH-98-1060; BIH-E-147; BIH-FDR001126
Record last reviewed:  June 1999
Last Updated:  October 13, 2004
Record first received:  October 18, 1999
ClinicalTrials.gov Identifier:  NCT00004419
Health Authority: United States: Federal Government
ClinicalTrials.gov processed this record on 2005-04-08