Protocol Number: 07-I-0094

Title:

Accuracy of Hemoglobin A1C to Predict Glycemia in HIV

Number:

07-I-0094

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 methods for monitoring blood sugar are preferred for HIV infected patients.

HIV-infected patients 18 years of age and older with type 2 diabetes or high blood sugar may be eligible for this study. Participants have two clinic visits (1 to 4 weeks apart) at the NIH Clinical Center. At the first visit they provide a detailed medical, social and family history and have blood and urine samples collected. Previous blood sugar values are also recorded. At the second visit, scheduled for 1 to 4 weeks after the first visit, blood and urine samples are collected. Some of the urine and blood samples are stored for future research on diabetes, HIV or related conditions.

Sponsoring Institute:

National Institute of Allergy and Infectious Diseases (NIAID)

Recruitment Detail

Type: Participants currently recruited/enrolled

Gender: Male & Female

Referral Letter Required: No

Population Exclusion(s): Children

Eligibility Criteria:

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.

Special Instructions:

Currently Not Provided

Keywords:

Hemoglobin A1C

HIV

Diabetes

Recruitment Keyword(s):

HIV

Diabetes Type 2

Hyperglycemia

Condition(s):

HIV Infections

Diabetes

Hyperglycemia

Investigational Drug(s):

None

Investigational Device(s):

None

Intervention(s):

None

Supporting Site:

National Institute of Allergy and Infectious Diseases

Contact(s):

Patient Recruitment and Public Liaison Office
Building 61
10 Cloister Court
Bethesda, Maryland 20892-4754
Toll Free: 1-800-411-1222
TTY: 301-594-9774 (local),1-866-411-1010 (toll free)
Fax: 301-480-9793

Electronic Mail:prpl@mail.cc.nih.gov

Citation(s):

Carr A, Samaras K, Burton S, Law M, Freund J, Chisholm DJ, Cooper DA. A syndrome of peripheral lipodystrophy, hyperlipidaemia and insulin resistance in patients receiving HIV protease inhibitors. AIDS. 1998 May 7;12(7):F51-8.

Dube MP, Parker RA, Tebas P, Grinspoon SK, Zackin RA, Robbins GK, Roubenoff R, Shafer RW, Wininger DA, Meyer WA 3rd, Snyder SW, Mulligan K. Glucose metabolism, lipid, and body fat changes in antiretroviral-naive subjects randomized to nelfinavir or efavirenz plus dual nucleosides. AIDS. 2005 Nov 4;19(16):1807-18.

Dube MP, Qian D, Edmondson-Melancon H, Sattler FR, Goodwin D, Martinez C, Williams V, Johnson D, Buchanan TA. Prospective, intensive study of metabolic changes associated with 48 weeks of amprenavir-based antiretroviral therapy. Clin Infect Dis. 2002 Aug 15;35(4):475-81. Epub 2002 Jul 23.

• Questions about participating in a study, please contact the Patient Recruitment and Public Liaison Office, CC.
• Technical questions regarding the Clinical Center web site, please contact the Department of Networks and Applications, CC.

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