The Role of 1.5-anhydro-D-glucitol as Clinical Biomarkers of Hypoglycemia in Patients With Diabetes

Type 2 Diabetes Mellitus With Hypoglycemia Clinical Trial

Official title:

1,5-Anhydro-D-Glucitol Can Reflect Hypoglycemia in Patients With Well Controlled Type 2 Diabetes

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02068300
• Other study ID #: 1,5AG_Hypo
• Status: Completed
• Phase: N/A
• First received: February 19, 2014
• Last updated: April 14, 2016
• Start date: October 2013
• Est. completion date: March 2016

Study information

• Verified date: April 2016
• Source: Seoul National University Hospital
• Contact: n/a
• Is FDA regulated: No
• Health authority: Korea: Institutional Review Board
• Study type: Observational

Clinical Trial Summary

The purpose of this study is to evaluate the usefulness of plasma 1,5-anhydro-D-glucitol (1,5-AG) as a novel surrogate marker of hypoglycemia

Description:

We enrolled well controlled diabetes patients who had hypoglycemic event at least one time more. All patients assess the risk of severe hypoglycemia and hypoglycemic unawareness using hypoglycemic awareness questionnaires (HYPO score). The patients who are treated with insulin agent were inserted sensor of continuous glucose monitoring systems under the skin during three days. We were analysed the correlation between 1,5-anhydro-D-glucitol and HYPO score.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 51
• Est. completion date: March 2016
• Est. primary completion date: February 2016
• Accepts healthy volunteers: No
• Gender: Both
• Age group: N/A and older

Eligibility

Inclusion Criteria:

• patients attending outpatients of department of endocrinology and metabolism, seoul national university hospital .(HbA1C <8%)

• The patients who treated with insulin or sulfonylureas at least 3month period

• In case fo sulfonylurea user, HbA1c was restricted under 8%

• The patients who had hypoglycemic event at least 3 months

• who has can be survey questionnaire

• who can insert continuous glucose monitoring system

Exclusion Criteria:

• renal dysfunction patients

• hepatic dysfunction patients

• who has any kind of diseases, operations, medical treatments that can affect glucose levels

Study Design

Observational Model: Case-Only, Time Perspective: Cross-Sectional

Related Conditions & MeSH terms

• Diabetes Mellitus, Type 2
• Hypoglycemia
• Type 2 Diabetes Mellitus With Hypoglycemia

Locations

Country	Name	City	State
Korea, Republic of	Seoul National University Hospital	Seoul

Sponsors (1)

Lead Sponsor	Collaborator
Seoul National University Hospital

Country where clinical trial is conducted

Korea, Republic of, 

References & Publications (1)

Kim MJ, Jung HS, Hwang-Bo Y, Cho SW, Jang HC, Kim SY, Park KS. Evaluation of 1,5-anhydroglucitol as a marker for glycemic variability in patients with type 2 diabetes mellitus. Acta Diabetol. 2013 Aug;50(4):505-10. doi: 10.1007/s00592-011-0302-0. Epub 201 — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	The plasma 1,5-anhydro-D-glucitol level may be a useful marker of daily glucose excursion in diabetes patients		24 hours	No
Primary	The correlation between 1,5-anhydro-D-glucitol and Modified Hypoglycemic score	Modified hypoglycemic score was calculated by modified Clarke et al. questionnaire.	within the least 3 months	No
Secondary	The correlation between hypoglycemic percent of Continuous glucose monitoring system and modified hypoglycemic score in insulin using patients.	Modified hypoglycemic score was calculated by modified Clarke et al. questionnaire.; Continuous glucose monitoring system was performed to find hypoglycemic event and glycemic variability in insulin using patients.	within at leat 3months	No
Secondary	The relation between glycemic variability indices such as MAGE of continuous glucose monitoring system and 1,5-AG in insulin using patients.	1,5-AG was measured from patient's serum. Continuous glucose monitoring system was performed to find hypoglycemic event and glycemic variability in insulin using patients.	within at least 3months	No