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

Type 2 Diabetes Mellitus Clinical Trial

Official title:

Correlation Between 1,5-anhydroglucitol and Postprandial Hyperglycemia by Continuous Glucose Monitoring System and Clinical Usefulness of 1,5-anhydroglucitol in Well-controlled Diabetic Patients

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01161797
• Other study ID #: KMC-ENDO-0801
• Status: Completed
• Phase: N/A
• First received: July 13, 2010
• Last updated: September 29, 2010
• Start date: February 2008
• Est. completion date: July 2010

Study information

• Verified date: September 2010
• Source: Kyunghee University Medical Center
• Contact: n/a
• Is FDA regulated: No
• Health authority: Korea: Institutional Review Board
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 53
• Est. completion date: July 2010
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 65 Years

Eligibility

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

Observational Model: Cohort, Time Perspective: Prospective

Related Conditions & MeSH terms

• Diabetes Mellitus
• Diabetes Mellitus, Type 2
• Hyperglycemia
• Type 2 Diabetes Mellitus

Locations

Country	Name	City	State
Korea, Republic of	Kyunghee University Medical Center	Seoul

Sponsors (1)

Lead Sponsor	Collaborator
Kyunghee University Medical Center

Country where clinical trial is conducted

Korea, Republic of, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	postprandial hyperglycemia		3days	No
Primary	glucose variability		3 days	No