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This study was conducted to test the possibility of preventing or delaying the development of type 2 diabetes in individuals with impaired glucose tolerance and elevated fasting plasma glucose concentrations by internet-based diabetes prevention program.
Diabetes is common and rapidly increasing, because of obesity, unhealthy eating habits, and physical inactivity in Korea. Many studies reported that lifestyle modification related in the primary prevention of diabetes in multiethnic populations. The aim of this study is to determine whether internet-based interventions in those at high risk may delay the development of type 2 diabetes mellitus, and thereby reduce the incidence of cardiovascular diseases and strokes in Korean populations. In January 2008, participant recruitment began in Chung-ju city, a rural area in Korea. The subjects with impaired glucose tolerance or elevated fasting plasma glucose concentrations were selected from initial screening and then randomized to either a control or intensive lifestyle group to carry out intervention over 4 years. The primary outcome of this study is the development of diabetes by ADA criteria. To confirm the onset of diabetes, all subjects have an OGTT at the interim 6-month and each annual visit. Also, systematic evaluation examination will be done at the same time. The proportion of subjects developing diabetes in each group and the factors relating the progression will be estimated using statistical analysis.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Lifestyle counseling | Active Comparator |
| |
| Standard care | Active Comparator |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Lifestyle counseling | Behavioral | In intervention group, counseling sessions are conducted weekly for 3 months, once per two weeks for 3 months, monthly for 18 months, and then once every two months for the remainder of the study. |
| Measure | Description | Time Frame |
|---|---|---|
| Incidence of Type 2 Diabetes Mellitus | Incidence of type 2 diabetes mellitus | one year follow up |
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Inclusion Criteria:
Age of 30-69 years
BMI ≥ 20 kg/m2
Impaired glucose tolerance :
2h postprandial glucose (75 g OGTT) 140-199 mg/dl or Impaired fasting glucose : Fasting plasma glucose 110-125 mg/dl
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Kun-Ho Yoon, M.D., Ph.D. | Kangnam St.Mary's hospital | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Chung-ju health care center | Chungju | Chungchungbook-do | South Korea |
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| ID | Title | Description |
|---|---|---|
| FG000 | Lifestyle Counseling | Lifestyle counseling: In intervention group, counseling sessions are conducted weekly for 3 months, once per two weeks for 3 months, monthly for 18 months, and then once every two months for the remainder of the study. |
| FG001 | Standard Care | Standard care: In standard care group, counseling sessions are conducted only 6 times for 4 years |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Lifestyle Counseling | Lifestyle counseling: In intervention group, counseling sessions are conducted weekly for 3 months, once per two weeks for 3 months, monthly for 18 months, and then once every two months for the remainder of the study. |
| BG001 | Standard Care |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Incidence of Type 2 Diabetes Mellitus | Incidence of type 2 diabetes mellitus | Posted | Number | participants | one year follow up |
|
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Lifestyle Counseling | Lifestyle counseling: In intervention group, counseling sessions are conducted weekly for 3 months, once per two weeks for 3 months, monthly for 18 months, and then once every two months for the remainder of the study. |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Kun-Ho Yoon, professor | The Catholic University of Korea | 82-2-2258-8281 | yoonk@catholic.ac.kr |
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| ID | Term |
|---|---|
| D003924 | Diabetes Mellitus, Type 2 |
| D009765 | Obesity |
| D018149 | Glucose Intolerance |
| D009043 | Motor Activity |
| ID | Term |
|---|---|
| D003920 | Diabetes Mellitus |
| D044882 | Glucose Metabolism Disorders |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |
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| ID | Term |
|---|---|
| D059039 | Standard of Care |
| ID | Term |
|---|---|
| D019984 | Quality Indicators, Health Care |
| D011787 | Quality of Health Care |
| D006298 | Health Services Administration |
| D017530 | Health Care Quality, Access, and Evaluation |
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| Standard care | Behavioral | In standard care group, counseling sessions are conducted only 6 times for 4 years |
|
Standard care: In standard care group, counseling sessions are conducted only 6 times for 4 years |
| BG002 | Total | Total of all reporting groups |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Units | Counts |
|---|
| Participants |
|
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| 0 |
| 0 |
| 0 |
| 0 |
| EG001 | Standard Care | Standard care: In standard care group, counseling sessions are conducted only 6 times for 4 years | 0 | 0 | 0 | 0 |
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| D004700 | Endocrine System Diseases |
| D050177 | Overweight |
| D044343 | Overnutrition |
| D009748 | Nutrition Disorders |
| D001835 | Body Weight |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D006943 | Hyperglycemia |
| D001519 | Behavior |