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Application and Effectiveness Analysis of Internet-based Diabetes Prevention Program

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ClinicalTrials.gov Identifier: NCT01085682
Recruitment Status : Completed
First Posted : March 12, 2010
Results First Posted : September 12, 2014
Last Update Posted : September 12, 2014
Sponsor:
Information provided by (Responsible Party):
Kun-Ho Yoon, The Catholic University of Korea

Study Description
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Brief Summary:
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.

Condition or disease Intervention/treatment Phase
Type 2 Diabetes Behavioral: Lifestyle counseling Behavioral: Standard care Phase 4

Detailed Description:
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.
Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 59 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Prevention
Official Title: Application and Effectiveness Analysis of Internet-based Diabetes Prevention Program
Study Start Date : January 2008
Actual Primary Completion Date : November 2013
Actual Study Completion Date : November 2013

Resource links provided by the National Library of Medicine


Arms and Interventions
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Arm Intervention/treatment
Active Comparator: Lifestyle counseling Behavioral: 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.
Active Comparator: Standard care Behavioral: Standard care
In standard care group, counseling sessions are conducted only 6 times for 4 years


Outcome Measures
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Primary Outcome Measures :
  1. Incidence of Type 2 Diabetes Mellitus [ Time Frame: one year follow up ]
    Incidence of type 2 diabetes mellitus


Eligibility Criteria
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Ages Eligible for Study:   30 Years to 69 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

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:

  • Diabetes at baseline
  • Cardiovascular disease, cancer requiring treatment in the past 5 years, renal disease
  • Unable to communicate with clinic staff, Pregnancy and childbearing
Contacts and Locations
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Information from the National Library of Medicine

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): NCT01085682


Locations
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Korea, Republic of
Chung-ju health care center
Chung-ju, Chungchungbook-do, Korea, Republic of
Sponsors and Collaborators
The Catholic University of Korea
Investigators
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Study Director: Kun-Ho Yoon, M.D., Ph.D. Kangnam St.Mary's hospital
More Information
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Responsible Party: Kun-Ho Yoon, Professor, Medical doctor, The Catholic University of Korea
ClinicalTrials.gov Identifier: NCT01085682    
Other Study ID Numbers: KCMC07OT255
First Posted: March 12, 2010    Key Record Dates
Results First Posted: September 12, 2014
Last Update Posted: September 12, 2014
Last Verified: September 2014
Keywords provided by Kun-Ho Yoon, The Catholic University of Korea:
Diabetes prevention
Lifestyle modification
Obesity
 Impaired glucose tolerance
Diet
Physical activity
Additional relevant MeSH terms:
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Diabetes Mellitus
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases