- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02981121
Hospital-based Diabetes Prevention Study in Korea
Hospital-based Diabetes Prevention Study in Korea: A Prospective, Multi-center, Randomized, Open-label Controlled Study
Study Overview
Status
Conditions
Intervention / Treatment
Study Type
Enrollment (Anticipated)
Phase
- Phase 4
Contacts and Locations
Study Contact
- Name: Jeong-Taek Woo
- Phone Number: 822-958-8220
- Email: jtwoomd@khmc.or.kr
Study Contact Backup
- Name: Sang Youl Rhee
- Phone Number: 822-958-8220
- Email: bard95@hanmail.net
Study Locations
-
-
-
Seoul, Korea, Republic of, 02447
- Recruiting
- Kyunghee University Medical Center
-
Contact:
- Jeong-taek Woo, MD, PhD
- Phone Number: +82-2-958-8128
- Email: jtwoomd@khmc.or.kr
-
Contact:
- Sang Youl Rhee, MD, PhD
- Phone Number: +82-2-958-8220
- Email: bard95@hanmail.net
-
Principal Investigator:
- Jeong-taek Woo, MD, PhD
-
Sub-Investigator:
- Suk Chon, MD, PhD
-
Sub-Investigator:
- Sang Youl Rhee, MD, PhD
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- 30<Age<71
- BMI≥23 kg/m2
- '75g Oral glucose tolerance 2 hours after the test Blood glucose140~199mg/dL' or 'Fasting Blood Sugar 110~125 mg/dL' or 'HbA1c 5.7%~6.4%'
Exclusion Criteria:
- Who diagnosed with Diabetes Mellitus or Who having Drugs for Diabetes Mellitus.
Type 2 Diabetes Mellitus
- Who diagnosed with Diabetes Mellitus except for maternity period.
- Who have had drugs for Diabetes Mellitus(hypoglycemic agent or insulin) except for maternity period.
- Fasting Glucose≥ 126 mg/dL
- 75g Oral glucose tolerance 2 hours after the Blood glucose ≥ 200 mg/dL
- HbA1c ≥ 6.5%
Who life expectancy is short.
Cardiac history
- History of severe cardiovascular disease within the last 6 months (cerebral hemorrhage, stroke, myocardial infarction, angina pectoris, heart failure, etc.)
- Systolic blood pressure >180 mmHg or Diastolic blood pressure >105 mmHg
- aortic stenosis
- Left bundle branch block or Third degree AV block
- Who had been diagnosed and treated for malignant tumors including leukemia and lymphoma within the last 5 years
- Abnormal renal function (Creatinine ≥ 1.4 mg/dL (male) or ≥ 1.3 mg/dL (female) or Urine Protein ≥ 2 +)
- Anemia(Hematocrit <36%((male) or><33%(female)) ⑤ Cirrhosis or chronic active hepatitis (AST/ALT>3UNL)
- Acute gastrointestinal disease (pancreatitis, infectious intestinal disease)
- Who is scheduled major surgery within the last 3 to 6 months or just after the surgery.
- Chronic infection (HIV, active tuberculosis, etc.)
- Pulmonary patients who rely on oxygen or daily bronchodilators
Who is judged to be able to influence the clinical trial by investigator.
- Who can not communicate
- Those with psychiatric or cognitive impairment that may affect the compliance of the clinical trial
- Those who do not agree to the treatment group allocation by random assignment
- Those who participate in other studies that may interfere with the clinical trial
- Those who lost weight by more than 10% during the past 6 months, excluding weight loss after giving birth
- Those who can not have normal walking or exercise
- Women who are pregnant
- Those who are currently pregnant or who are within the last 3 months after giving birth
- Those planning pregnancy during the clinical trial period
- Those who have a history of drug and alcohol abuse (acute, chronic) within the last 2 years
- Those who are not appropriate or unreliable for clinical trials at the discretion of the tester
Who taking medication or medical condition that may affect the diagnosis of diabetes
- Thiazide diuretics
- Systemic beta blockers
- Taking Niacin for the treatment of neutropenic depression
- Possibility of taking or injecting a systemic steroid preparation
- Taking a serotonin reuptake inhibitor (SSRI) for weight loss purpose.
- Taking medicine for weight loss
- Hormone status is not appropriate during thyroid hormone replacement therapy (TSH abnormal range) (If thyroid hormone therapy is stable for more than 3 months and TSH is normal, the patient can participate in)
- Others with other endocrine diseases (eg Cushing's syndrome, acromegaly)
- During treatment, fasting plasma triglyceride> 600 mg / dL
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Prevention
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
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).
|
|
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.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Cumulative incidence of Diabetes Mellitus after randomization
Time Frame: 36 months from the baseline
|
Definition of "incidence of Diabetes Mellitus"
|
36 months from the baseline
|
Secondary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Change on HbA1c
Time Frame: 12, 24, 36 months from the baseline
|
12, 24, 36 months from the baseline
|
Change on Fasting Glucose
Time Frame: 12, 24, 36 months from the baseline
|
12, 24, 36 months from the baseline
|
Change on HOMA2%S
Time Frame: 12, 24, 36 months from the baseline
|
12, 24, 36 months from the baseline
|
Change on HOMA2%B
Time Frame: 12, 24, 36 months from the baseline
|
12, 24, 36 months from the baseline
|
Collaborators and Investigators
Sponsor
Collaborators
Publications and helpful links
Study record dates
Study Major Dates
Study Start
Primary Completion (Anticipated)
Study Completion (Anticipated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- KDPS
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
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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