HIVNCT00433628
Accuracy of Hemoglobin A1C to Predict Glycemia in HIV
An observational study of HIV and Diabetes, run by National Institute of Allergy and Infectious Diseases (NIAID) at 2 sites in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- HIV, Diabetes, Hyperglycemia
- How many people
- 175 participants
- Where
- 2 sitesUnited States
- Study dates
- 7 Feb 2007to 12 Nov 2008
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
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- 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.
Trial locations and contacts
2 sites in 1 country.
United States2 sites
National Institutes of Health Clinical Center, 9000 Rockville Pike
Bethesda, Maryland, 20892
Washington Hospital Center
Washington D.C., District of Columbia, 20010
About this study
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.
...
Read the 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 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.
- Conditions
- HIV, Diabetes, Hyperglycemia
- Keywords
- Hemoglobin A1C, HIV, Diabetes, Diabetes Type 2, Hyperglycemia
- Medical subject headings
- Diabetes Mellitus, Hyperglycemia, Diabetes Mellitus, Type 2
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Feb 2007 (estimated)
- Study start7 Feb 2007
- Primary completion12 Nov 2008
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HIVStudies of the same condition, open and under way.
- More trials run by National Institute of Allergy and Infectious Diseases (NIAID)The sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Time perspective
- Prospective
- Enrolment
- 175 participants
Sponsor and investigators
- Sponsor type
- US National Institutes of Health
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00433628
- Sponsor's protocol ID
- 070094
- Other IDs
- 07-I-0094
- Status last verified
- 25 Aug 2009
- First submitted
- 9 Feb 2007
- Last updated
- 2 Jul 2017
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 2 Jul 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Accuracy of Hemoglobin A1C to Predict Glycemia in HIV
- ClinicalTrials.gov ID
- NCT00433628
- Acronym / sponsor ID
- 070094
- Conditions
- HIV, Diabetes, Hyperglycemia
- Keywords
- Hemoglobin A1C, HIV, Diabetes, Diabetes Type 2, Hyperglycemia
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 175 participants
- Lead sponsor
- National Institute of Allergy and Infectious Diseases (NIAID)US National Institutes of Health
- Study start
- 7 Feb 2007
- Primary completion
- 12 Nov 2008 (actual)
- First posted
- 12 Feb 2007 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
...
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 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.
Study design
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Documented + HIV ELISA.
- 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.
- 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.
Key exclusion criteria (11 listed)
- 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).
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Not reported in the source record.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Jul 2017.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of HIV and Diabetes, run by National Institute of Allergy and Infectious Diseases (NIAID) at 2 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 11 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 2 Jul 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 Jul 2017.