- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02726256
G-CREDIT (Gangnam-Cohort for Risk Evaluation of Diabetes and Impaired Glucose Tolerance)
April 15, 2016 updated by: Yonsei University
The prevalence of type 2 diabetes has consistently increased and type 2 diabetes can cause many types of vascular complications.
Diabetes develops due to glucose intolerance.
Early detection and intervention in the stage of glucose intolerance makes it afford to prevent overt diabetes and its complications.
This study was designed to make a cohort of korean patients with glucose intolerance to construct a long term database about clinical characteristics of these patients.
Study Overview
Status
Not yet recruiting
Conditions
Study Type
Observational
Enrollment (Anticipated)
500
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Contact
- Name: Chul Woo Ahn, MD
- Phone Number: 82-02-2019-3339
- Email: acw@yuhs.ac
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
20 years to 100 years (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Sampling Method
Non-Probability Sample
Study Population
Patients with either type 2 diabetes or impaired glucose toloerance who are older than 20 years old and have attended Gangnam Severance hospital for regular follow up.
Description
Inclusion Criteria:
- Patients older than 20 years old who has visited Gangnam severance hospital since January 2007.
- Patients with either diabetes or impaired glucose tolerance
- Patients with at least 6 months of follow-up period
Exclusion Criteria:
1. Patients with gestational diabetes, any active stage of cancer and severe disability
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
|---|
|
Diabetes and Impaired glucose Tolerance (G-CREDIT)
Patients with either type 2 diabetes or impaired glucose tolerance who are older than 20 years old and have attended Gangnam Severance hospital for regular follow up.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Life style assessment - Past medical history - Smoking, alcohol history - Sleep, exercise, daily activity check - Diet - Reproductive status (Women only) - Socioeconomic status
Time Frame: an expected average of 12 weeks
|
Measuring above all, investigators plan to investigate how clinical parameters help to predict and prevent diabetic vascular complications
|
an expected average of 12 weeks
|
|
Past medical history
Time Frame: an expected average of 12 weeks
|
Measuring above all, investigators plan to investigate how clinical parameters help to predict and prevent diabetic vascular complications
|
an expected average of 12 weeks
|
|
Smoking, alcohol history
Time Frame: an expected average of 12 weeks
|
Measuring above all, investigators plan to investigate how clinical parameters help to predict and prevent diabetic vascular complications
|
an expected average of 12 weeks
|
|
Sleep, exercise, daily activity check
Time Frame: an expected average of 12 weeks
|
Measuring above all, investigators plan to investigate how clinical parameters help to predict and prevent diabetic vascular complications
|
an expected average of 12 weeks
|
|
Diet
Time Frame: an expected average of 12 weeks
|
Measuring above all, investigators plan to investigate how clinical parameters help to predict and prevent diabetic vascular complications
|
an expected average of 12 weeks
|
|
Reproductive status (Women only)
Time Frame: an expected average of 12 weeks
|
Measuring above all, investigators plan to investigate how clinical parameters help to predict and prevent diabetic vascular complications
|
an expected average of 12 weeks
|
|
Socioeconomic status
Time Frame: an expected average of 12 weeks
|
Measuring above all, investigators plan to investigate how clinical parameters help to predict and prevent diabetic vascular complications
|
an expected average of 12 weeks
|
|
Anthropometric measurements : Height, weight, waist circumference, pulse rate, blood pressure
Time Frame: an expected average of 12 weeks
|
Measuring above all, investigators plan to investigate how clinical parameters help to predict and prevent diabetic vascular complications
|
an expected average of 12 weeks
|
|
SMA, TG, HDL, LDLM apoA, apoB
Time Frame: an expected average of 12 weeks
|
Measuring above all, investigators plan to investigate how clinical parameters help to predict and prevent diabetic vascular complications
|
an expected average of 12 weeks
|
|
PC2hrs, HbA1C, Insulin, C-peptide (AC, PC2hr), hs-CRP
Time Frame: an expected average of 12 weeks
|
Measuring above all, investigators plan to investigate how clinical parameters help to predict and prevent diabetic vascular complications
|
an expected average of 12 weeks
|
|
Urine protein, albumin, creatinine
Time Frame: an expected average of 12 weeks
|
Measuring above all, investigators plan to investigate how clinical parameters help to predict and prevent diabetic vascular complications
|
an expected average of 12 weeks
|
|
EKG, Neurometer, Chest PA, Abdominal sonography
Time Frame: an expected average of 12 weeks
|
Measuring above all, investigators plan to investigate how clinical parameters help to predict and prevent diabetic vascular complications
|
an expected average of 12 weeks
|
|
Fundus photography, fat computed tomography
Time Frame: an expected average of 12 weeks
|
Measuring above all, investigators plan to investigate how clinical parameters help to predict and prevent diabetic vascular complications
|
an expected average of 12 weeks
|
|
HOMA-IR, HOMA-β
Time Frame: an expected average of 12 weeks
|
Measuring above all, investigators plan to investigate how clinical parameters help to predict and prevent diabetic vascular complications
|
an expected average of 12 weeks
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
January 1, 2007
Primary Completion (Anticipated)
February 1, 2026
Study Completion (Anticipated)
February 1, 2026
Study Registration Dates
First Submitted
March 27, 2016
First Submitted That Met QC Criteria
March 27, 2016
First Posted (Estimate)
April 1, 2016
Study Record Updates
Last Update Posted (Estimate)
April 18, 2016
Last Update Submitted That Met QC Criteria
April 15, 2016
Last Verified
April 1, 2016
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- 3-2010-0195
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
YES
IPD Plan Description
This study has a plan to share data
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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