Study of Recombinant Human Insulin-Like Growth Factor I in Patients With Severe Insulin Resistance
insulin-like growth factor I
Hyperinsulinism+8
+ Metabolic Diseases
+ Nutritional and Metabolic Diseases
Treatment Study
Summary
Study start date: April 1, 1998
Actual date on which the first participant was enrolled.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
Protocol
This section provides details of the study plan, including how the study is designed and what the study is measuring.18 patients to be enrolled
Total number of participants that the clinical trial aims to recruit.Treatment Study
Eligibility
Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.Any sex
Biological sex of participants that are eligible to enroll.From 14 to 65 Years
Range of ages for which participants are eligible to join.Healthy volunteers not allowed
If individuals who are healthy and do not have the condition being studied can participate.Conditions
Pathology
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
Study Centers
These are the hospitals, clinics, or research facilities where the trial is being conducted. You can find the location closest to you and its status.This study has 1 location
Beth Israel Deaconess Medical Center
Boston, United StatesOpen Beth Israel Deaconess Medical Center in Google Maps