Study of Recombinant Human Insulin-Like Growth Factor I in Patients With Severe Insulin Resistance
Recruitment status was Recruiting
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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.
| Condition | Intervention |
|---|---|
|
Insulin Resistance Hyperglycemia |
Drug: insulin-like growth factor I |
| Study Type: | Interventional |
| Study Design: | Masking: Open Label Primary Purpose: Treatment |
| 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.
Eligibility| Ages Eligible for Study: | 14 Years to 65 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
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
Contacts and Locations| 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 |
More Information
No publications provided
| ClinicalTrials.gov Identifier: | NCT00004419 History of Changes |
| Other Study ID Numbers: | 199/13313, BIH-98-1060, BIH-E-147, BIH-FDR001126 |
| Study First Received: | October 18, 1999 |
| Last Updated: | June 23, 2005 |
| Health Authority: | United States: Federal Government |
Keywords provided by FDA Office of Orphan Products Development:
|
endocrine disorders insulin resistance rare disease |
Additional relevant MeSH terms:
|
Hyperglycemia Insulin Resistance Glucose Metabolism Disorders Metabolic Diseases Hyperinsulinism Complement Factor I Mitogens Insulin |
Complement Inactivating Agents Immunosuppressive Agents Immunologic Factors Physiological Effects of Drugs Pharmacologic Actions Mitosis Modulators Molecular Mechanisms of Pharmacological Action Hypoglycemic Agents |
ClinicalTrials.gov processed this record on May 23, 2013