The Correlation Between HbA1c and Mean Blood Glucose in Patients With Diabetes and Renal Failure

NCT01937858 | Terminated

• 1 other identifier: RC08/107/A
• Study Type: observational
• Target: 50
• Locations: 0 countries
• Sites: N/A

Brief 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. 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

Outcome Measures

Primary Outcomes (1)

• Correlation

  The quantitative correlation between mean blood glucose and HbA1c in patients with diabetes and renal failure

  three months

Study Arms (3)

Normal renal function

Stage 2 and 4 and 5 chronic kidney disease

End stage renal disease on hemodialysis

Eligibility Criteria

• Age: 18 Years - 90 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

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.

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Reem Mohammad Alamoudi: lead

MeSH Terms

Conditions

Diabetes Mellitus; Renal Insufficiency

Condition Hierarchy (Ancestors)

Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases; Kidney Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Consultant Endocrinology

Study Record Dates

• First Submitted: September 4, 2013
• First Posted: September 10, 2013
• Study Start: July 1, 2012
• Primary Completion: March 1, 2016
• Study Completion: July 1, 2016
• Last Updated: February 20, 2020

Record last verified: 2020-02