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Application and Effectiveness Analysis of Community-Based Diabetes Prevention Program in Korea

Not Applicable
Recruiting
Conditions
Endocrine, nutritional and metabolic disease
Registration Number
KCT0001981
Lead Sponsor
The Catholic University of Korea
Brief Summary

Not available

Detailed Description

Not available

Recruitment & Eligibility

Status
Recruiting
Sex
All
Target Recruitment
420
Inclusion Criteria

Adults 30-64 years
-Body mass index (BMI) = 23 kg/m2
-Impaired fasting glucose (IFG) or impaired glucose tolerance (IGT) according to the criteria of the World Health Organization (WHO)

Exclusion Criteria

- Subjects who diagnosed with diabetes mellitus
· Fasting plasma glucose (FPG) = 126 mg/dL or HbA1c = 6.5%
· 2-h plasma glucose (PG) = 200 mg/dL based on 75-g OGTT
- Subjects who previously admitted for cardiovascular disease within 6 months
- Subjects who had a history of aortic stenosis, left bundle block or third degree atrioventricular block or who had a pacemaker
- Subjects who previously diagnosed with renal disease (creatinine = 1.4 mg/dl in men, or = 1.3 mg/dl in women)
- Subjects who previously diagnosed with malignant disease within 5 years
- Subjects who have anemia (hematocrit < 36 % in men or < 33 % in women)
- Subjects who have hepatitis or liver cirrhosis
- Subjects who have acute gastrointestinal disease
- Subjects who have a plan of surgery in 3-6 months
- Subjects who have chronic infection (human immunodeficiency virus, tuberculosis, etc.)
- Subjects with pulmonary disease, who need supplemental oxygen or bronchodilator therapy
- Subjects who cannot communicate effectively in Korean
- Subjects who do not want to receive any kind of intervention.
- Subjects who are pregnant or had delivery within 3 months or have a plan of pregnancy
- Subjects who have major psychiatric disease or heavy alcoholics
- Subjects who cannot walk 400 meters in 10 minutes
- Subjects who participate in different clinical studies or may not understand this study process.
- Subjects who had taken drugs or were clinical state described below
· Niacin, Glucocorticoids
· Selective serotonin re-uptake inhibitors in weight-reduction dose
· Other weight-loss medications
· Untreated thyroid disease or cushing's syndrome, acromegaly
· Fasting triglyceride level > 600 mg/dl despite therapy

Study & Design

Study Type
Interventional Study
Study Design
Not specified
Primary Outcome Measures
NameTimeMethod
Development of new diabetes mellitus
Secondary Outcome Measures
NameTimeMethod
Diatary intake;Physical activity;Quality of life;Physical strength
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