1,5 Anhydroglucitol and 1,5 Anhydroglucitol / Glycated Hemoglobin Ratio as a Potential Biomarker for Islet β-cell Function and Insulin Resistance Among Patients With Type 2 Diabetes Mellitus

March 22, 2022 updated by: Mona Youssry Helmy, Cairo University

Hyperglycemia is a major risk factor for the micro- and macro-vascular complications of diabetes . Lowering blood glucose levels has been shown to reduce the incidence of diabetes complications.

Therefore, there is a need for a simple surrogate biochemical marker for glycemic variability. Glycated hemoglobin (HbA1c) is the standard clinical measurement used to monitor glycemic status and is recommended to assess control of diabetes over the preceding 2-3 months. However, being a measure of mean glucose, it does not reflect glucose variability.

It is well known that insulin secretion defects of islet β cells and/or tissue insensitivity to insulin are common pathophysiological mechanisms of diabetes mellitus (DM) .

The elevation in the blood glucose level usually represents the degree of glucose metabolism disorder, which is generally assessed by glycated hemoglobin A1c ( HbA1c) and indirectly reflects the extent of β-cell function damage .

In the recent years, 1,5-anhydroglucitol (1,5-AG) has received attention as a short-term blood glucose index that reflects the average blood glucose level 1,5 AG reflects the average maximum blood glucose level during the past 1-2 weeks and is reported to be a more sensitive marker of glucose variability and postprandial hyperglycemia than HbA1c, even for patients with prediabetes and for those with well or moderately controlled diabetes .

(1,5 AG ) is structurally similar to glucose . Due to this similarity, glucose inhibits renal reabsorption of 1,5 AG by competitive inhibition ,resulting in an inverse correlation of 1,5 AG with hyperglycemia .

1,5-AG levels are acting as an effective supplement to HbA1c. Additionally, previous study showed that 1,5-AG and HbA1c had opposite curves with increasing blood glucose levels; specifically, with the increase in HbA1c levels, 1,5-AG levels decreased significantly . Therefore, we speculate a ratio of 1,5- AG / HB A1C in relation to islet β-cell function and insulin resistance.

The aim of our study was to evaluate the role of 1,5 anhydroglucitol and 1,5 anhydroglucitol / HbA1c ratio as a potential biomarker for islet β-cell function and insulin resistance among patients with type 2 diabetes .

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Anticipated)

90

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • Egypt
    • Manial
      • Cairo, Manial, Egypt, 11521
        • Recruiting
        • Cairo University
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

20 years to 70 years (Adult, Older Adult)

Accepts Healthy Volunteers

N/A

Genders Eligible for Study

All

Sampling Method

Probability Sample

Study Population

A case control study including 90 subjects aged 20 to 70 years, 45 healthy subjects as a control group and 45 patients with type 2 DM .Patients will be collected from the endocrinology outpatient clinic, Kasr El Ainy, Cairo University. Patients will be divided into 2 groups, (group I) 45 patients with type 2 DM and (group II) 45 non DM as control group.

Description

Inclusion Criteria:

  • Men and women aged 20 to 70 years old with controlled and uncontrolled type 2 DM.

Exclusion Criteria:

  • : type 1 DM,
  • thyroid dysfunction,
  • chronic kidney disease,
  • chronic liver disease,
  • cancer patients,
  • cystic fibrosis,
  • acute and chronic infection and
  • pregnancy

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Case-Control
  • Time Perspectives: Prospective

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
the role of 1,5 anhydroglucitol and 1,5 anhydroglucitol / HbA1c ratio as a potential biomarker for islet β-cell function and insulin resistance among patients with type 2 diabetes
Time Frame: 6 months
1,5 anhydroglucitol serum level, V level and 1,5 anhydroglucitol / HbA1c ratio
6 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Cairo University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

  • -Janssen J, van den Berg E, Zinman B , Espeland MA , Geijselaers S LC et al., (2019) . HbA(1c), insulin resistance, and β-cell function in relation to cognitive function in type 2 diabetes: the CAROLINA Cognition Substudy. Diabetes Care 42(1):e1-e3. -Kanat M, Winnier D, Norton L, Arar N, Jenkinson C, Defronzo RA et al ., (2011) . The relationship between {beta}-cell function and glycated hemoglobin: results from the veterans administration genetic epidemiology study. Diabetes Care. 2011 Apr;34(4):1006-10. -Kim MJ, Jung HS, Hwang-Bo Y, Cho SW, Jang HC, Kim SY et al ., (2013) . Evaluation of 1,5-anhydroglucitol as a marker for glycemic variability in patients with type 2 diabetes mellitus. Acta Diabetol. 2013;50:505-10.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

May 6, 2021

Primary Completion (Anticipated)

July 1, 2022

Study Completion (Anticipated)

October 1, 2022

Study Registration Dates

First Submitted

April 28, 2021

First Submitted That Met QC Criteria

April 28, 2021

First Posted (Actual)

May 3, 2021

Study Record Updates

Last Update Posted (Actual)

March 24, 2022

Last Update Submitted That Met QC Criteria

March 22, 2022

Last Verified

March 1, 2022

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • N-26-2021

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

IPD Plan Description

not to share

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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