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

Sponsor
Beth Israel Deaconess Medical Center (Other)
Overall Status
Completed
CT.gov ID
NCT00004419
Collaborator
(none)
18
Enrollment
1
Location
29
Duration (Months)
0.6
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

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.

  1. Determine the dose and time response of rhIGF-I on carbohydrate homeostasis and secondary abnormalities in this patient population.

  2. 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 or Disease Intervention/Treatment Phase
  • Drug: insulin-like growth factor I
 N/A

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 Design

Study Type:
Interventional
Anticipated Enrollment :
18 participants
Masking:
None (Open Label)
Primary Purpose:
Treatment
Study Start Date :
Apr 1, 1998
Study Completion Date :
Sep 1, 2000

Outcome Measures

Primary Outcome Measures

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    14 Years to 65 Years
    Sexes Eligible for Study:
    All
    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

    Locations

    Site City State Country Postal Code
    1 Beth Israel Deaconess Medical Center Boston Massachusetts United States 02215

    Sponsors and Collaborators

    • Beth Israel Deaconess Medical Center

    Investigators

    • Study Chair: Alan C. Moses, Beth Israel Deaconess Medical Center

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    , ,
    ClinicalTrials.gov Identifier:
    NCT00004419
    Other Study ID Numbers:
    • 199/13313
    • BIH-98-1060
    • BIH-E-147
    • BIH-FDR001126
    First Posted:
    Oct 19, 1999
    Last Update Posted:
    Mar 25, 2015
    Last Verified:
    Jun 1, 1999
    Keywords provided by , ,
    endocrine disorders
    insulin resistance
    rare disease
    Additional relevant MeSH terms:
    Insulin Resistance
    Hyperglycemia
    Mitogens

    Study Results

    No Results Posted as of Mar 25, 2015