DiabetesNCT01937858
The Correlation Between HbA1c and Mean Blood Glucose in Patients With Diabetes and Renal Failure
An observational study of Diabetes and Renal Failure, run by Reem Mohammad Alamoudi.
Trial summary
The value of HbA1c as a tool to determine glycemic control in patients with diabetes and renal failure has not been well studied, the same accepted normal ranges for HbA1c are applied to all patients with diabetes regardless of their renal function. Read more about this study
- Who is it for?
- Ages 18 to 90 years
- Conditions the study is for
- Diabetes, Renal Failure
- How many people
- 50 participants
- Where
- No sites listed yet
- Study dates
- Jul 2012to Jul 2016
- 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 to 90 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Our target population is patients with diabetes and impaired renal function. This study will include 80 adult patients with type1 or type 2 diabetes; 20 with normal serum creatinine, 40 with renal failure in the predialysis stage (20 with stage 3 and 4 CKD [GFR 0f 20-40] and 20 with stage 5 CKD not yet on hemodialysis [GFR <20]), and 20 on hemodialysis. All patients should be comfortable and committed to doing self-glucose monitoring.
Who may be able to join
- All patients >18 years of age with type 1 or 2 diabetes who show competence in home glucose monitoring and are willing to commit to doing the testing
Who cannot join
- Pregnancy
- Having received a blood transfusion with in the preceding three months
- Known to have any hereditary or hemolytic anemia
- On a medication known to interfere with HbA1c assay (opiates, acetaminophen, vitamin C, vitamin E) - we will allow patients to be on asprin as almost all patients with diabetes are on this drug.
- Having a blood hemoglobin <7 mg/dl
- Bilirubin level >20mg/dL or a triglyceride level > 250mg/dL
- Alcohol addiction
About this study
The value of HbA1c as a tool to determine glycemic control in patients with diabetes and renal failure has not been well studied, the same accepted normal ranges for HbA1c are applied to all patients with diabetes regardless of their renal function. We would like to evaluate the use of HbA1c as a tool of assessing long term glycemic control in this subgroup of patients with diabetes and evaluate the effect of dialysis on HbA1c
- Conditions
- Diabetes, Renal Failure
- Keywords
- HbA1c, glycated hemoglobin, correlation, diabetes, renal failure
- Medical subject headings
- Diabetes Mellitus, Renal Insufficiency
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Normal renal function | Not described | |
| Stage 2 and 4 and 5 chronic kidney disease | Not described | |
| End stage renal disease on hemodialysis | Not described |
What is being measured
The primary outcome is the main question the study is designed to answer.
Correlation
The quantitative correlation between mean blood glucose and HbA1c in patients with diabetes and renal failure
Measured: three months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Sep 2013 (estimated)
- Study startJul 2012
- Primary completionMar 2016
- Study completionJul 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for DiabetesStudies of the same condition, open and under way.
- 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
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 50 participants (actual)
Sponsor and investigators
- Lead sponsor
- Reem Mohammad Alamoudi
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Reem Mohammad Alamoudi, King Abdullah International Medical Research Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01937858
- Sponsor's protocol ID
- RC08/107/A
- Status last verified
- Feb 2020
- First submitted
- 4 Sep 2013
- Last updated
- 20 Feb 2020
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 20 Feb 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Correlation Between HbA1c and Mean Blood Glucose in Patients With Diabetes and Renal Failure
- ClinicalTrials.gov ID
- NCT01937858
- Acronym / sponsor ID
- RC08/107/A
- Conditions
- Diabetes, Renal Failure
- Keywords
- HbA1c, glycated hemoglobin, correlation, diabetes, renal failure
- Study type
- Observational
- Recruitment status
- Terminated
- Enrolment
- 50 participants (actual)
- Lead sponsor
- Reem Mohammad AlamoudiUniversity, hospital or other
- Study start
- Jul 2012
- Primary completion
- Mar 2016 (actual)
- Study completion
- Jul 2016 (actual)
- First posted
- 10 Sep 2013 (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.
The value of HbA1c as a tool to determine glycemic control in patients with diabetes and renal failure has not been well studied, the same accepted normal ranges for HbA1c are applied to all patients with diabetes regardless of their renal function. We would like to evaluate the use of HbA1c as a tool of assessing long term glycemic control in this subgroup of patients with diabetes and evaluate the effect of dialysis on HbA1c
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Normal renal function | – | – |
| Stage 2 and 4 and 5 chronic kidney disease | – | – |
| End stage renal disease on hemodialysis | – | – |
Who may qualify
- Ages
- 18 to 90 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Our target population is patients with diabetes and impaired renal function. This study will include 80 adult patients with type1 or type 2 diabetes; 20 with normal serum creatinine, 40 with renal failure in the predialysis stage (20 with stage 3 and 4 CKD [GFR 0f 20-40] and 20 with stage 5 CKD not yet on hemodialysis [GFR <20]), and 20 on hemodialysis. All patients should be comfortable and committed to doing self-glucose monitoring.
Key inclusion criteria (1 listed)
- All patients >18 years of age with type 1 or 2 diabetes who show competence in home glucose monitoring and are willing to commit to doing the testing
Key exclusion criteria (7 listed)
- Pregnancy
- Having received a blood transfusion with in the preceding three months
- Known to have any hereditary or hemolytic anemia
- On a medication known to interfere with HbA1c assay (opiates, acetaminophen, vitamin C, vitamin E) - we will allow patients to be on asprin as almost all patients with diabetes are on this drug.
- Having a blood hemoglobin <7 mg/dl
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
Correlation
Time frame: three months
The quantitative correlation between mean blood glucose and HbA1c in patients with diabetes and renal failure
Results and safety
The study was stopped early. Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Feb 2020.
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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.
Questions about this trial
What is this clinical trial studying?
An observational study of Diabetes and Renal Failure, run by Reem Mohammad Alamoudi.
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 1 inclusion and 7 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: stopped early, as of the sponsor's last update on 20 Feb 2020. Status can change between updates, so confirm with the study contact before making plans.
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 was stopped early. Results are not available in the source record.
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.
What does the primary outcome measure?
Correlation (time frame: three months). It is what the study was designed to measure, not a finding.
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 20 Feb 2020.