NCT01161797

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
53

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started Feb 2008

Typical duration for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

February 1, 2008

Completed
2.4 years until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2010

Completed
12 days until next milestone

First Submitted

Initial submission to the registry

July 13, 2010

Completed
1 day until next milestone

First Posted

Study publicly available on registry

July 14, 2010

Completed
Last Updated

September 30, 2010

Status Verified

September 1, 2010

First QC Date

July 13, 2010

Last Update Submit

September 29, 2010

Conditions

Keywords

1,5-Anhydroglucitol

Outcome Measures

Primary Outcomes (2)

  • postprandial hyperglycemia

    3days

  • glucose variability

    3 days

Eligibility Criteria

Age18 Years - 65 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

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

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Kyunghee University Medical Center

Seoul, 130-702, South Korea

Location

Biospecimen

Retention: SAMPLES WITHOUT DNA

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

MeSH Terms

Conditions

Diabetes Mellitus, Type 2

Condition Hierarchy (Ancestors)

Diabetes MellitusGlucose Metabolism DisordersMetabolic DiseasesNutritional and Metabolic DiseasesEndocrine System Diseases

Study Officials

  • Jeong-taek Woo, MD, PhD

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

    STUDY DIRECTOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER

Study Record Dates

First Submitted

July 13, 2010

First Posted

July 14, 2010

Study Start

February 1, 2008

Study Completion

July 1, 2010

Last Updated

September 30, 2010

Record last verified: 2010-09

Locations