Study of Recombinant Human Insulin-Like Growth Factor I in Patients With Severe Insulin Resistance

Beth Israel Lahey Health

Status: Completed

Conditions: Hyperglycemia; Insulin Resistance

Treatments: Drug: insulin-like growth factor I

Study type: Interventional

Funder types: Other

Identifiers

NCT00004419

BIH-98-1060

BIH-E-147

BIH-FDR001126

199/13313

Details and patient eligibility

About

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.

Full description

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

Enrollment: 18 estimated patients

Sex: All

Ages: 14 to 65 years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion 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