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Completed

NCT Number: NCT01161797

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

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.

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Key information

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Kyunghee University Medical Center

Seoul, 130-702, South Korea

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Primary outcomes

  1. postprandial hyperglycemia

    Time frame: 3days

  2. glucose variability

    Time frame: 3 days

Sponsors and collaborators

Lead sponsor

Kyunghee University Medical Center

Other

Registry information

Official study 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

Important dates

Study start
2008
Study completion
2010
First posted
Jul 14, 2010
Registry last updated
Sep 30, 2010

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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