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

This study has been completed.
Sponsor:
Information provided by:
Kyunghee University Medical Center
ClinicalTrials.gov Identifier:
NCT01161797
First received: July 13, 2010
Last updated: September 29, 2010
Last verified: September 2010
  Purpose

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
Type 2 Diabetes Mellitus

Study Type: Observational
Study Design: 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

Resource links provided by NLM:


Further study details as provided by Kyunghee University Medical Center:

Primary Outcome Measures:
  • postprandial hyperglycemia [ Time Frame: 3days ] [ Designated as safety issue: No ]
  • glucose variability [ Time Frame: 3 days ] [ Designated as safety issue: No ]

Biospecimen Retention:   Samples Without DNA

serum (HbA1c, fructosamine, 1,5-anhydroglucitol)


Enrollment: 53
Study Start Date: February 2008
Study Completion Date: July 2010
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.

  Eligibility

Ages Eligible for Study:   18 Years to 65 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population

Well-controlled patients with type 2 diabetes with HbA1c<7%

Criteria

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
  Contacts and Locations
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Please refer to this study by its ClinicalTrials.gov identifier: NCT01161797

Locations
Korea, Republic of
Kyunghee University Medical Center
Seoul, Korea, Republic of, 130-702
Sponsors and Collaborators
Kyunghee University Medical Center
Investigators
Study Director: Jeong-taek Woo, MD, PhD Department of Endocrinology and Metabolism, Kyung Hee University School of Medicine, Seoul, Korea
  More Information

No publications provided

Responsible Party: Jeong-taek Woo, MD, PhD, Kyunghee University Medical Center
ClinicalTrials.gov Identifier: NCT01161797     History of Changes
Other Study ID Numbers: KMC-ENDO-0801
Study First Received: July 13, 2010
Last Updated: September 29, 2010
Health Authority: Korea: Institutional Review Board

Keywords provided by Kyunghee University Medical Center:
1,5-Anhydroglucitol

Additional relevant MeSH terms:
Diabetes Mellitus
Diabetes Mellitus, Type 2
Hyperglycemia
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases

ClinicalTrials.gov processed this record on September 18, 2014