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Status:

ACTIVE_NOT_RECRUITING

Effect of Metreleptin Therapy in the Treatment of Severe Insulin Resistance

Lead Sponsor:

National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)

Conditions:

Severe Insulin Resistance

Eligibility:

All Genders

5+ years

Phase:

PHASE2

Brief Summary

Study Description: Patients with mutations of the insulin receptor have diabetes that is challenging to control with conventional therapies, leading to early morbidity and mortality. We hypothesize t...

Detailed Description

Study Description: Patients with mutations of the insulin receptor have diabetes that is challenging to control with conventional therapies, leading to early morbidity and mortality. We hypothesize t...

Eligibility Criteria

Inclusion

  • INCLUSION CRITERIA:
  • Provision of signed and dated informed consent form
  • Male or female, aged \> 5 years
  • Clinically significant, severe insulin resistance caused by a known or suspected defect in the insulin receptor
  • Presence of at least one of the following metabolic abnormalities:
  • Fasting insulin \>30 micro U/ml, or
  • Presence of diabetes as defined by the 2006 American Diabetes Association (ADA) criteria:
  • Fasting plasma glucose \>= 126 mg/dL
  • 2 hour plasma glucose \>= 200 mg/dL following a 75 gram (1.75g/kg if less than 40kg) oral glucose load, or
  • Diabetic symptoms with a random plasma glucose \>= 200 mg/dL
  • EXCLUSION CRITERIA:
  • Pregnant at time of enrollment, women in their reproductive years who do not use an effective method of birth control, and women currently nursing or lactating within 6 weeks of having completed nursing.
  • Known infectious liver disease
  • Known HIV infection
  • Current alcohol or substance abuse
  • Active tuberculosis
  • Use of anorexigenic drugs
  • Other conditions which in the opinion of the clinical investigators would impede completion of the study.
  • Subjects who have a known hypersensitivity to E. Coli derived proteins.

Exclusion

    Key Trial Info

    Start Date :

    August 21 2003

    Trial Type :

    INTERVENTIONAL

    Allocation :

    ACTUAL

    End Date :

    January 1 2030

    Estimated Enrollment :

    11 Patients enrolled

    Trial Details

    Trial ID

    NCT00085982

    Start Date

    August 21 2003

    End Date

    January 1 2030

    Last Update

    January 30 2025

    Active Locations (1)

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    Page 1 of 1 (1 locations)

    1

    National Institutes of Health Clinical Center, 9000 Rockville Pike

    Bethesda, Maryland, United States, 20892