Status:

COMPLETED

Accuracy of Hemoglobin A1C to Predict Glycemia in HIV

Lead Sponsor:

National Institute of Allergy and Infectious Diseases (NIAID)

Conditions:

HIV

Diabetes

Eligibility:

All Genders

18+ years

Brief Summary

This study will see if HbA1C, the usual blood test for monitoring blood sugar control in diabetic patients, is as accurate in diabetic patients who also have HIV and will evaluate if alternative metho...

Detailed Description

Diabetes mellitus is increasingly recognized among patients living with human immunodeficiency virus (HIV) infection. At present, there are no unique guidelines for the management of diabetes in patie...

Eligibility Criteria

Inclusion

  • INCLUSION CRITERIA:
  • Documented + HIV ELISA.
  • Diabetes mellitus (DM) will be defined as:
  • Documented diagnosis of type 2 diabetes mellitus or FPG greater than or equal to 126 mg/dl on two occasions or casual blood glucose greater than or equal to 200 mg/dL and symptoms of diabetes.
  • Impaired Fasting Glucose (IFG) defined as:
  • FPG greater than or equal to 100 mg/dl and less than 126 mg/dl on one or more occasions within past year.
  • Age 18+, male or female.
  • EXCLUSION CRITERIA:
  • Type 1 Diabetes.
  • Known current pregnancy or pregnancy within 6 mo.
  • Documented hemoglobinopathy.
  • Changes in antiretroviral therapy within 3 months.
  • History of anemia (Hb less than 9g/dL in past 6 months).
  • Active opportunistic Infection or opportunistic Infection within 3 mo.
  • Creatine greater than 1.8 mg/dL or known end stage renal disease (ESRD).
  • Changes in diabetes therapies within 3 mo (excluding dose adjustments).
  • Subject is deemed unable to comply with requirements of study participation.
  • Use of oral corticosteroid within the past 3 mo (stable dose inhaled steroids will be allowed).
  • Blood transfusion within 3 months.

Exclusion

    Key Trial Info

    Start Date :

    February 7 2007

    Trial Type :

    OBSERVATIONAL

    End Date :

    Estimated Enrollment :

    175 Patients enrolled

    Trial Details

    Trial ID

    NCT00433628

    Start Date

    February 7 2007

    Last Update

    July 2 2017

    Active Locations (2)

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    Page 1 of 1 (2 locations)

    1

    Washington Hospital Center

    Washington D.C., District of Columbia, United States, 20010

    2

    National Institutes of Health Clinical Center, 9000 Rockville Pike

    Bethesda, Maryland, United States, 20892

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