Hospital-based Diabetes Prevention Study in Korea
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|ClinicalTrials.gov Identifier: NCT02981121|
Recruitment Status : Unknown
Verified July 2017 by Jeong-taek Woo, Kyunghee University Medical Center.
Recruitment status was: Recruiting
First Posted : December 2, 2016
Last Update Posted : July 25, 2017
|Condition or disease||Intervention/treatment||Phase|
|PreDiabetes||Behavioral: Exercise and Diet remedies Drug: Metformin||Phase 4|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||744 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|Official Title:||Hospital-based Diabetes Prevention Study in Korea: A Prospective, Multi-center, Randomized, Open-label Controlled Study|
|Study Start Date :||November 2016|
|Estimated Primary Completion Date :||November 2019|
|Estimated Study Completion Date :||November 2020|
No Intervention: Conventional Management
A patient will receive 30 minutes of individual education from the investigator, based on the standard guidelines of the Korean Diabetes Association. And will be followed up every 6 months for 36 months.
Experimental: Life style modification
Proceed according to the Intervention Protocol developed by the Nutrition Committee of the Korean Diabetes Association. Aim to lose more than 5% of weight within 6 months, and then aim to keep weight loss constantly. After randomization, the diabetes educator team (physician / nurse / dietician) applies the intervention program for exercise therapy and diet therapy, and manages it through online education (telephone visit) and offline education (institution visit).
Behavioral: Exercise and Diet remedies
Active Comparator: Metformin
After randomization, take 250 mg once a day for 2 weeks. If there is no side effect, take 500 mg once a day for 2 weeks. If there are no side effects, the maximum dose can be increased to 1000mg.
- Cumulative incidence of Diabetes Mellitus after randomization [ Time Frame: 36 months from the baseline ]
Definition of "incidence of Diabetes Mellitus"
- Fasting Glucose ≥126 mg/dL or
- 75g Oral glucose tolerance test 2 hours after the Blood glucose ≥ 200 mg / dL or
- Change on HbA1c [ Time Frame: 12, 24, 36 months from the baseline ]
- Change on Fasting Glucose [ Time Frame: 12, 24, 36 months from the baseline ]
- Change on HOMA2%S [ Time Frame: 12, 24, 36 months from the baseline ]
- Change on HOMA2%B [ Time Frame: 12, 24, 36 months from the baseline ]
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02981121
|Contact: Jeong-Taek Wooemail@example.com|
|Contact: Sang Youl Rheefirstname.lastname@example.org|
|Korea, Republic of|
|Kyunghee University Medical Center||Recruiting|
|Seoul, Korea, Republic of, 02447|
|Contact: Jeong-taek Woo, MD, PhD +82-2-958-8128 email@example.com|
|Contact: Sang Youl Rhee, MD, PhD +82-2-958-8220 firstname.lastname@example.org|
|Principal Investigator: Jeong-taek Woo, MD, PhD|
|Sub-Investigator: Suk Chon, MD, PhD|
|Sub-Investigator: Sang Youl Rhee, MD, PhD|