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Completed

NCT Number: NCT01085682

Application and Effectiveness Analysis of Internet-based Diabetes Prevention Program

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.

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Key information

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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.

Standard Care

Behavioral

In standard care group, counseling sessions are conducted only 6 times for 4 years

Primary outcomes

  1. Incidence of Type 2 Diabetes Mellitus

    Time frame: one year follow up

    Incidence of type 2 diabetes mellitus

Sponsors and collaborators

Lead sponsor

The Catholic University of Korea

Other

Registry information

Important dates

Study start
2008
Primary completion
2013
Study completion
2013
First posted
Mar 12, 2010
Registry last updated
Sep 12, 2014

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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