- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00004419
Study of Recombinant Human Insulin-Like Growth Factor I in Patients With Severe Insulin Resistance
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.
Study Overview
Status
Conditions
Intervention / Treatment
Detailed 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
Study Type
Enrollment (Anticipated)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
Massachusetts
-
Boston, Massachusetts, United States, 02215
- Beth Israel Deaconess Medical Center
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
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 Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Masking: None (Open Label)
Collaborators and Investigators
Investigators
- Study Chair: Alan C. Moses, Beth Israel Deaconess Medical Center
Study record dates
Study Major Dates
Study Start
Study Completion
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Estimate)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 199/13313
- BIH-98-1060
- BIH-E-147
- BIH-FDR001126
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Hyperglycemia
-
Mayo ClinicCompletedHospital Hyperglycemia | Post-transplant HyperglycemiaUnited States
-
Zealand University HospitalNot yet recruitingStress Hyperglycemia | Postoperative Hyperglycemia
-
University of CopenhagenUnknownSurgery--Complications | Hyperglycemia Stress | Hyperglycemia Steroid-inducedDenmark
-
University of LeedsCompletedEffect of Food on Postprandial HyperglycemiaUnited Kingdom
-
Emory UniversityNational Institute of Diabetes and Digestive and Kidney Diseases (NIDDK); National...RecruitingHyperglycemia StressUnited States
-
Loughborough UniversityUniversity of BedfordshireCompletedPostprandial HyperglycemiaUnited Kingdom
-
Centre Hospitalier Universitaire de BesanconEli Lilly and Company; AstraZenecaCompleted
-
Medical University of ViennaCompleted
-
Addis Ababa UniversityCompletedHyperglycemia, Postprandial
-
University of Eastern FinlandFinnsugar LtdCompletedHyperglycemia, PostprandialFinland
Clinical Trials on insulin-like growth factor I
-
Children's Hospital of PhiladelphiaCompleted
-
Children's Hospital of PhiladelphiaCompleted
-
Bispebjerg HospitalThe Danish Medical Research CouncilUnknown
-
Wright State UniversityRecruitingAging | UVB Phototherapy Burn | Insulin-like Growth Factor 1United States
-
FDA Office of Orphan Products DevelopmentChildren's Hospital of PhiladelphiaCompleted
-
Astellas Pharma IncCompleted
-
Children's Hospital of Fudan UniversityCompleted
-
Mayo ClinicNational Institute of Neurological Disorders and Stroke (NINDS); ALS Association and other collaboratorsCompletedAmyotrophic Lateral SclerosisUnited States, Puerto Rico
-
Massachusetts General HospitalCompletedDisorder of Bone Density and Structure, UnspecifiedUnited States