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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01161797
Recruitment Status : Completed
First Posted : July 14, 2010
Last Update Posted : September 30, 2010
Information provided by:
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.

Condition or disease
Type 2 Diabetes Mellitus

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.

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Study Type : Observational
Actual Enrollment : 53 participants
Observational Model: Cohort
Time Perspective: Prospective
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
Study Start Date : February 2008
Actual Study Completion Date : July 2010

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Hyperglycemia

Primary Outcome Measures :
  1. postprandial hyperglycemia [ Time Frame: 3days ]
  2. glucose variability [ Time Frame: 3 days ]

Biospecimen Retention:   Samples Without DNA
serum (HbA1c, fructosamine, 1,5-anhydroglucitol)

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population
Well-controlled patients with type 2 diabetes with HbA1c<7%

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT01161797

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Korea, Republic of
Kyunghee University Medical Center
Seoul, Korea, Republic of, 130-702
Sponsors and Collaborators
Kyunghee University Medical Center
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Study Director: Jeong-taek Woo, MD, PhD Department of Endocrinology and Metabolism, Kyung Hee University School of Medicine, Seoul, Korea
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Responsible Party: Jeong-taek Woo, MD, PhD, Kyunghee University Medical Center Identifier: NCT01161797    
Other Study ID Numbers: KMC-ENDO-0801
First Posted: July 14, 2010    Key Record Dates
Last Update Posted: September 30, 2010
Last Verified: September 2010
Keywords provided by Kyunghee University Medical Center:
Additional relevant MeSH terms:
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Diabetes Mellitus
Diabetes Mellitus, Type 2
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases