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Home > "S" Clinical Trials Conditions > Study of Recombinant Human Insulin-Like Growth Factor I in Patients with Severe Insulin Resistance  Study of Recombinant Human Insulin-Like Growth Factor I in Patients with Severe Insulin Resistance
Study of Recombinant Human Insulin-Like Growth Factor I in Patients with Severe Insulin Resistance
For Condition: Insulin Resistance,Hyperglycemia
Status: Recruiting
Sponsor(s): FDA Office of Orphan Products Development , Beth Israel Deaconess Medical Center
Synopsis: 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.
Details: 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:
Study Type: Interventional, Treatment, Open Label
Minimum Age/Maximum Age: 14 Years/65 Years
Genders: Both
Protocol Entry 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
Total Enrollment: 18
Location and Contact Information:
Overall Study Official:
AlanMoses, Study Chair, Beth Israel Deaconess Medical Center
Beth Israel Deaconess Medical Center *Recruiting*
Boston, Massachusetts, 02215
United States
Recruiting Alan Moses 617-667-4269
Additional Information:
Study ID Numbers: 199/13313; BIH-98-1060,BIH-E-147,BIH-FDR001126
Study Start Date: April 1998
Record last reviewed: June 1999
Additional information available at: clinicaltrials.gov
Clinicaltrials.gov Reference link: NCT00004419
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Study of Recombinant Human Insulin-Like Growth Factor I in Patients with Severe Insulin Resistance
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