Expired Study
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Boston, Massachusetts 02215


Purpose:

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.


Study summary:

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


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


NCT ID:

NCT00004419


Primary Contact:

Study Chair
Alan C. Moses
Beth Israel Deaconess Medical Center


Backup Contact:

N/A


Location Contact:

Boston, Massachusetts 02215
United States



There is no listed contact information for this specific location.

Site Status: N/A


Data Source: ClinicalTrials.gov

Date Processed: September 20, 2017

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