Ignite Creation Date:
2025-12-25 @ 3:30 AM
Ignite Modification Date:
2025-12-26 @ 2:11 AM
Study NCT ID:
NCT04869605
Status:
UNKNOWN
Last Update Posted:
2022-03-24
First Post:
2021-04-28
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief 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
Sponsor:
Cairo University
Organization:
Study Overview
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
Status:
UNKNOWN
Status Verified Date:
2022-03
Last Known Status:
RECRUITING
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief 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 .
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 .
Detailed Description:
None
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: