Impaired Glucose ToleranceNCT01034826
Progression to Impaired Glucose Tolerance and Type 2 Diabetes in the Korean People-based KNDP Study
An observational study of Impaired Glucose Tolerance and Diabetes, run by Korea University Guro Hospital.
Trial summary
Impaired glucose tolerance is a metabolic state between normal glucose homeostasis and diabetes. Previously, prospective studies have shown higher progression rates from IGT to diabetes in other country. But There is no prospective-multicenter based reports in Korea. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Impaired Glucose Tolerance, Diabetes
- How many people
- 500 participants
- Where
- No sites listed yet
- Study dates
- Feb 2007to May 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 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: patients who vist the endocrinology department due to impaired fasting glucose or impaired glucose tolerance, or both.
Who may be able to join
- fastic serum glucose >100 and/or pp2 serum glucose <200
Who cannot join
- known diabetes
- organ failure(For example, liver, kidney)
- known malignancy
About this study
Impaired glucose tolerance is a metabolic state between normal glucose homeostasis and diabetes. Previously, prospective studies have shown higher progression rates from IGT to diabetes in other country. But There is no prospective-multicenter based reports in Korea. Therefore, the purpose of this study is to estimate the progression rates to impair glucose regulation and diabetes in the Korean population-based Korea national Diabetes program.
- Conditions
- Impaired Glucose Tolerance, Diabetes
- Keywords
- NGT, IGT, diabetes
- Medical subject headings
- Glucose Intolerance, Diabetes Mellitus
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| life style modification | everyone in this study was advised about their life style, diet, exercise habits. |
What is being measured
The primary outcome is the main question the study is designed to answer.
fasting serum glucose, fasting plasma insulin,post prandial serum glucose, post prandial plasma insulin, hbA1c
Measured: 0.1.3.5 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Dec 2009 (estimated)
- Study startFeb 2007
- Primary completionDec 2009
- Study completionMay 2010
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Impaired Glucose ToleranceStudies 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
- Case only
- Time perspective
- Prospective
- Enrolment
- 500 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Korea University Guro Hospital
- Sponsor type
- University, hospital or other
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01034826
- Sponsor's protocol ID
- KNDP IGT study
- Status last verified
- Dec 2009
- First submitted
- 17 Dec 2009
- Last updated
- 9 Jun 2010
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Choi KM, Hwang SY, Hong HC, Yang SJ, Choi HY, Yoo HJ, Lee KW, Nam MS, Park YS, Woo JT, Kim YS, Choi DS, Youn BS, Baik SH. C1q/TNF-related protein-3 (CTRP-3) and pigment epithelium-derived factor (PEDF) concentrations in patients with type 2 diabetes and metabolic syndrome. Diabetes. 2012 Nov;61(11):2932-6. doi: 10.2337/db12-0217. Epub 2012 Jul 26.
PubMed 22837306
Study at a glance
From the registry record, last updated by the sponsor on 9 Jun 2010. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Progression to Impaired Glucose Tolerance and Type 2 Diabetes in the Korean People-based KNDP Study
- ClinicalTrials.gov ID
- NCT01034826
- Acronym / sponsor ID
- KNDP IGT study
- Conditions
- Impaired Glucose Tolerance, Diabetes
- Keywords
- NGT, IGT, diabetes
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 500 participants (estimated)
- Lead sponsor
- Korea University Guro HospitalUniversity, hospital or other
- Study start
- Feb 2007
- Primary completion
- Dec 2009 (actual)
- Study completion
- May 2010 (actual)
- First posted
- 18 Dec 2009 (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.
Impaired glucose tolerance is a metabolic state between normal glucose homeostasis and diabetes. Previously, prospective studies have shown higher progression rates from IGT to diabetes in other country. But There is no prospective-multicenter based reports in Korea. Therefore, the purpose of this study is to estimate the progression rates to impair glucose regulation and diabetes in the Korean population-based Korea national Diabetes program.
Study design
- Observational model
- Case only
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| life style modification | – | –everyone in this study was advised about their life style, diet, exercise habits. |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- patients who vist the endocrinology department due to impaired fasting glucose or impaired glucose tolerance, or both.
Key inclusion criteria (1 listed)
- fastic serum glucose >100 and/or pp2 serum glucose <200
Key exclusion criteria (3 listed)
- known diabetes
- organ failure(For example, liver, kidney)
- known malignancy
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
fasting serum glucose, fasting plasma insulin,post prandial serum glucose, post prandial plasma insulin, hbA1c
Time frame: 0.1.3.5 year
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 9 Jun 2010.
- Derived from this study: PubMed 22837306Choi KM, Hwang SY, Hong HC, Yang SJ, Choi HY, Yoo HJ, Lee KW, Nam MS, Park YS, Woo JT, Kim YS, Choi DS, Youn BS, Baik SH. C1q/TNF-related protein-3 (CTRP-3) and pigment epithelium-derived factor (PEDF) concentrations in patients with type 2 diabetes and metabolic syndrome. Diabetes. 2012 Nov;61(11):2932-6. doi: 10.2337/db12-0217. Epub 2012 Jul 26.
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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.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
An observational study of Impaired Glucose Tolerance and Diabetes, run by Korea University Guro Hospital.
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 1 inclusion and 3 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 9 Jun 2010. Status can change between updates, so confirm with the study contact before making plans.
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?
fasting serum glucose, fasting plasma insulin,post prandial serum glucose, post prandial plasma insulin, hbA1c (time frame: 0.1.3.5 year). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01034826, which also lists 1 linked publication.
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 9 Jun 2010.