- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01161797
1,5-AG as a Marker of Postprandial Hyperglycemia and Glucose Variability in Well-controlled Type 2 Diabetes Mellitus
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 Overview
Status
Conditions
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.
Study Type
Enrollment (Actual)
Contacts and Locations
Study Locations
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Seoul, Korea, Republic of, 130-702
- Kyunghee University Medical Center
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Sampling Method
Study Population
Description
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 Plan
How is the study designed?
Design Details
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
postprandial hyperglycemia
Time Frame: 3days
|
3days
|
glucose variability
Time Frame: 3 days
|
3 days
|
Collaborators and Investigators
Investigators
- Study Director: Jeong-taek Woo, MD, PhD, Department of Endocrinology and Metabolism, Kyung Hee University School of Medicine, Seoul, Korea
Study record dates
Study Major Dates
Study Start
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Estimate)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- KMC-ENDO-0801
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