1,5-AG as a Marker of Postprandial Hyperglycemia and Glucose Variability in Well-controlled Type 2 Diabetes Mellitus

Completed

• Conditions: Type 2 Diabetes Mellitus

• Registration Number: NCT01161797
• Lead Sponsor: Kyunghee University Medical Center

Brief Summary

The aim of this study was to evaluate the correlation between 1,5-Anhydroglucitol in patients with HbA1C \<7%, and glycemic excursions as assessed by the continuous glucose monitoring system compared to fructosamine.

Detailed Description

1,5-Anhydroglucitol (AG) is a glucose analogue present in the plasma of healthy subjects. Physiologically, the plasma levels of 1,5-AG are very stable and only a small quantity is excreted in the urine. It is competitively reabsorbed with glucose in the renal tubules. Therefore, in the hyperglycemic state where glycosuria is present, glucose competitively inhibits renal tubular reabsorption of 1,5-AG and consequently the plasma 1,5-AG levels decrease. When glycemia is normalized and glycosuria is resolved, 1,5-AG levels increase.

The usefulness of 1, 5-AG in reflecting glycemic excursions have been demonstrated in moderately controlled patients to some extent, although some studies reveal controversial results.

Therefore, the aim of this study was to evaluate the association of 1,5-AG and postprandial hyperglycemia determined using the Continuous Glucose Monitoring System (CGMS) in DM patients with HbA1C\<7% and evaluate the usefulness of 1,5-AG as a marker of glycemic control compared to HbA1C and fructosamine.

Study Timeline

• Study Start: 2008-02
• Study Completion: 2010-07
• Study First Submitted: 2010-07-13
• Study First Submitted QC: 2010-07-13
• Study First Posted: 2010-07-14
• Status Verified: 2010-09
• Last Update Submitted: 2010-09-29
• Last Update Posted: 2010-09-30

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 53

Inclusion Criteria

• HbA1C < 7%
• HbA1c modification <0.5% in the previous 3 months
• no recent addition of oral hypoglycemic medications or change in insulin dose >10% previous 3 months

Exclusion Criteria

• pregnancy
• anemia (Hb <10.0 g/dL)
• liver disease (ALT >2 UNL)
• hypoalbuminemia (albumin <3.5 g/dL)
• serum creatinine >2 mg/dL
• acute or chronic renal tubulointerstitial disease
• severe medical illness

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
postprandial hyperglycemia	3days
glucose variability	3 days

Trial Locations

Locations (1)

Kyunghee University Medical Center; 🇰🇷 Seoul, Korea, Republic of