Accuracy of Hemoglobin A1C to Predict Glycemia in HIV
| Status: | Completed |
|---|---|
| Conditions: | HIV / AIDS, Diabetes |
| Therapuetic Areas: | Endocrinology, Immunology / Infectious Diseases |
| Healthy: | No |
| Age Range: | 18 - Any |
| Updated: | 4/21/2016 |
| Start Date: | February 2007 |
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.
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.
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.
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.
- 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.
We found this trial at
2
sites
110 Irving St NW
Washington, District of Columbia 20010
Washington, District of Columbia 20010
(202) 877-7000
Washington Hosp Ctr MedStar Washington Hospital Center is a not-for-profit, 926-bed, major teaching and research...
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9000 Rockville Pike
Bethesda, Maryland 20892
Bethesda, Maryland 20892
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