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Sponsors and Collaborators: |
FDA Office of Orphan Products Development Beth Israel Deaconess Medical Center |
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Information provided by: | FDA Office of Orphan Products Development |
ClinicalTrials.gov Identifier: | NCT00004419 |
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 | Intervention |
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Insulin Resistance Hyperglycemia |
Drug: insulin-like growth factor I |
Study Type: | Interventional |
Study Design: | Treatment, Open Label |
Estimated Enrollment: | 18 |
Study Start Date: | April 1998 |
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 to 65 Years |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
PROTOCOL ENTRY CRITERIA:
--Disease Characteristics--
--Prior/Concurrent Therapy--
Endocrine therapy: No concurrent oral hypoglycemic agents and/or insulin
Other: No concurrent birth control pills
--Patient Characteristics--
United States, Massachusetts | |
Beth Israel Deaconess Medical Center | Recruiting |
Boston, Massachusetts, United States, 02215 | |
Contact: Alan C. Moses 617-667-4269 |
Study Chair: | Alan C. Moses | Beth Israel Deaconess Medical Center |
Study ID Numbers: | 199/13313, BIH-98-1060, BIH-E-147, BIH-FDR001126 |
Study First Received: | October 18, 1999 |
Last Updated: | June 23, 2005 |
ClinicalTrials.gov Identifier: | NCT00004419 History of Changes |
Health Authority: | United States: Federal Government |
endocrine disorders insulin resistance rare disease |
Hyperinsulinism Hypoglycemic Agents Metabolic Diseases Hyperglycemia Rare Diseases Mitogens |
Endocrine System Diseases Endocrinopathy Insulin Resistance Glucose Metabolism Disorders Metabolic Disorder Insulin |
Hyperinsulinism Hypoglycemic Agents Metabolic Diseases Hyperglycemia Molecular Mechanisms of Pharmacological Action Physiological Effects of Drugs |
Mitosis Modulators Mitogens Insulin Resistance Glucose Metabolism Disorders Pharmacologic Actions Insulin |