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

Diabetes Mellitus Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04869605
• Other study ID #: N-26-2021
• Status: Recruiting
• Start date: May 6, 2021
• Est. completion date: October 2022

Study information

• Verified date: March 2022
• Source: Cairo University
• Contact: Nehal H Elsaid
• Phone: 01004389020
• Email: nihalhamdyelsaid[@]yahoo.com
• Is FDA regulated: No
• Study type: Observational [Patient Registry]

Clinical Trial Summary

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 .

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 90
• Est. completion date: October 2022
• Est. primary completion date: July 2022
• Gender: All
• Age group: 20 Years to 70 Years

Eligibility

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

Related Conditions & MeSH terms

• Diabetes Mellitus
• Diabetes Mellitus, Type 2
• Insulin Resistance

Intervention

Diagnostic Test:
• 1,5 Anhydroglucitol and 1,5 Anhydroglucitol / Glycated Hemoglobin ratio
the role of 1,5 anhydroglucitol and 1,5 anhydroglucitol / HbA1c ratio as a potential biomarker for islet ß-cell function and insulin resistance among patients with type 2 diabetes

Locations

Country	Name	City	State
Egypt	Cairo University	Cairo	Manial

Sponsors (1)

Lead Sponsor	Collaborator
Cairo University

Country where clinical trial is conducted

Egypt, 

References & Publications (1)

-Janssen J, van den Berg E, Zinman B , Espeland MA , Geijselaers S LC et al., (2019) . HbA(1c), insulin resistance, and ß-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.

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	the role of 1,5 anhydroglucitol and 1,5 anhydroglucitol / HbA1c ratio as a potential biomarker for islet ß-cell function and insulin resistance among patients with type 2 diabetes	1,5 anhydroglucitol serum level, V level and 1,5 anhydroglucitol / HbA1c ratio	6 months