Type 2 Diabetes MellitusNCT01161797
1,5-AG as a Marker of Postprandial Hyperglycemia and Glucose Variability in Well-controlled Type 2 Diabetes Mellitus
An observational study of Type 2 Diabetes Mellitus, run by Kyunghee University Medical Center at 1 site in South Korea.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Type 2 Diabetes Mellitus
- How many people
- 53 participants
- Where
- 1 siteSouth Korea
- Study dates
- Feb 2008to Jul 2010
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Well-controlled patients with type 2 diabetes with HbA1c<7%
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
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
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.
Read the 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.
- Conditions
- Type 2 Diabetes Mellitus
- Keywords
- 1,5-Anhydroglucitol
- Medical subject headings
- Diabetes Mellitus, Type 2
What is being measured
The primary outcome is the main question the study is designed to answer.
postprandial hyperglycemia
Measured: 3days
glucose variability
Measured: 3 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Jul 2010 (estimated)
- Study startFeb 2008
- Study completionJul 2010
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Type 2 Diabetes MellitusStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 53 participants (actual)
Sponsor and investigators
- Lead sponsor
- Kyunghee University Medical Center
- Sponsor type
- University, hospital or other
- Investigators
- Jeong-taek Woo, MD, PhD, Study director, Department of Endocrinology and Metabolism, Kyung Hee University School of Medicine, Seoul, Korea
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01161797
- Sponsor's protocol ID
- KMC-ENDO-0801
- Status last verified
- Sep 2010
- First submitted
- 13 Jul 2010
- Last updated
- 30 Sep 2010
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 30 Sep 2010. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT01161797
- Acronym / sponsor ID
- KMC-ENDO-0801
- Conditions
- Type 2 Diabetes Mellitus
- Keywords
- 1,5-Anhydroglucitol
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 53 participants (actual)
- Lead sponsor
- Kyunghee University Medical CenterUniversity, hospital or other
- Study start
- Feb 2008
- Study completion
- Jul 2010 (actual)
- First posted
- 14 Jul 2010 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
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 design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Well-controlled patients with type 2 diabetes with HbA1c<7%
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (7 listed)
- pregnancy
- anemia (Hb <10.0 g/dL)
- liver disease (ALT >2 UNL)
- hypoalbuminemia (albumin <3.5 g/dL)
- serum creatinine >2 mg/dL
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
postprandial hyperglycemia
Time frame: 3days
glucose variability
Time frame: 3 days
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Sep 2010.
Related trials for Type 2 Diabetes Mellitus
Not yet recruitingPhase 3
Efficacy and Safety of Once-Weekly SHR-3167 Compared With Once-Daily Insulin Glargine in Adults With Insulin-Naive Type 2 Diabetes
Type 2 Diabetes
Active, not recruiting
Digital Reinforcement of Motivational Interviewing Micro-Skills Among Primary Care Healthcare Professionals
Hypertension (Without Type 2 Diabetes Mellitus)
Recruiting
Investigating Vascular Properties of HEMI and SPG Signals in Individuals With or at Risk for Chronic Kidney Disease
Chronic Kidney Disease, Hypertension (HTN)
Not yet recruitingPhase 3
A Study to Evaluate the Effectiveness and Safety of the Drug AZD6234 for Managing Weight in Adults Who Are Obese or Overweight. These Participants May or May Not Also Have Type 2 Diabetes
Obesity, Overweight
Not yet recruiting
Impact of Endoscopic Sleeve Gastroplasty (ESG) in Obese Adults With Type 2 Diabetes (T2D)
Type 2 Diabetes Mellitus (T2D), Obesity (BMI>30)
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Jeong-taek Woo, MD, PhD study director
Department of Endocrinology and Metabolism, Kyung Hee University School of Medicine, Seoul, Korea
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Type 2 Diabetes Mellitus, run by Kyunghee University Medical Center at 1 site in South Korea.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 30 Sep 2010. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in South Korea. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
postprandial hyperglycemia (time frame: 3days). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 30 Sep 2010; AzTrials last refreshed its copy on 7 Nov 2026.