Accuracy of Hemoglobin A1C to Predict Glycemia in HIV
National Institute of Allergy and Infectious Diseases (NIAID)
Information provided by (Responsible Party)
National Institutes of Health Clinical Center (CC)
First received: February 9, 2007
Last updated: June 30, 2017
Last Verified: August 25, 2009
History of Changes
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.
Time Perspective: Prospective
|Official Title:||Accuracy of Hemoglobin A1C to Predict Glycemia in HIV|
Further study details as provided by National Institutes of Health Clinical Center (CC):
|Study Start Date:||February 7, 2007|
|Primary Completion Date:||November 12, 2008 (Final data collection date for primary outcome measure)|
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 patients with HIV. Diabetes in this population is managed in
accordance with national guidelines for the management of diabetes in any patient. However,
there have been small studies suggesting that hemoglobin A1C (HbA1C) may not be indicative of
true glycemic control in HIV positive patients. There are currently no published prospective
studies examining the ability of HbA1C to reflect glycemic control in HIV positive patients
with diabetes. Since the incidence of HIV positive patients with lipodystrophy, glucose
intolerance, and diabetes is steadily increasing with the widespread use of highly active
antiretroviral therapy (HAART), the question of how best to monitor hyperglycemia in these
patients is an important one.
This study, a prospective cross-sectional study of 100 patients, seeks to collect preliminary data to determine if HbA1C is appropriately reflecting plasma glucose in HIV positive patients. Patients with HIV and diabetes or hyperglycemia will have a fasting and a random plasma glucose and HbA1C collected as in normal diabetes patient care. They will also have two validated alternate markers of glycemic control drawn, fructosamine and Glycomark [R], to determine how well these markers may reflect actual glycemia. Fructosamine represents a measure of protein glycosylation whereas Glycomark [R] is a monosaccharide in plasma competitively inhibited in the renal tubules by glucose that reflects day-to-day hyperglycemia. In addition, hemolysis will be assessed to investigate this as one potential mechanism for why HbA1C may be a less accurate representation of glycemia in these patients. The determination of the value of HbA1C as a marker of glycemia in HIV positive patients with diabetes will assist with the monitoring and the management of this unique population with diabetes. The measurement of other glycemic markers may provide evidence towards potential superior markers of glycemia in these patients, and the study will provide insight into the possible mechanism of the HbA1C discrepancy.
|Ages Eligible for Study:||18 Years and older|
|Sexes Eligible for Study:||All|
|Accepts Healthy Volunteers:||No|
- INCLUSION CRITERIA:
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.
Type 1 Diabetes.
Known current pregnancy or pregnancy within 6 mo.
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.
Contacts and LocationsChoosing to participate in a study is an important personal decision.Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below.For general information, see Learn About Clinical Studies.
Please refer to this study by its ClinicalTrials.gov identifier: NCT00433628
Locations Show More
|United States, District of Columbia|
|Washington Hospital Center|
|Washington, D.C., District of Columbia, United States, 20010|
|United States, Maryland|
|National Institutes of Health Clinical Center, 9000 Rockville Pike|
|Bethesda, Maryland, United States, 20892|
Sponsors and CollaboratorsNational Institute of Allergy and Infectious Diseases (NIAID)
|Responsible Party:||National Institute of Allergy and Infectious Diseases (NIAID)|
|ClinicalTrials.gov Identifier:||NCT00433628 History of Changes|
|Other Study ID Numbers:||070094|
|Study First Received:||February 9, 2007|
|Last Updated:||June 30, 2017|
Keywords provided by National Institutes of Health Clinical Center (CC):Hemoglobin A1C
Diabetes Type 2
Additional relevant MeSH terms:
ClinicalTrials.gov processed this data on March 23, 2018
This information is provided by ClinicalTrials.gov.