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

NCT ID: NCT01161797

Last Updated: 2010-09-30

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

53 participants

Study Classification

OBSERVATIONAL

Study Start Date

2008-02-29

Study Completion Date

2010-07-31

Brief Summary

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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

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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.

Conditions

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Type 2 Diabetes Mellitus

Keywords

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1,5-Anhydroglucitol

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Kyunghee University Medical Center

OTHER

Sponsor Role lead

Responsible Party

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Kyunghee University Medical Center

Principal Investigators

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Jeong-taek Woo, MD, PhD

Role: STUDY_DIRECTOR

Department of Endocrinology and Metabolism, Kyung Hee University School of Medicine, Seoul, Korea

Locations

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Kyunghee University Medical Center

Seoul, , South Korea

Site Status

Countries

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South Korea

Other Identifiers

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KMC-ENDO-0801

Identifier Type: -

Identifier Source: org_study_id