Application and Effectiveness Analysis of Internet-based Diabetes Prevention Program

Phase 4

Completed

• Conditions: Type 2 Diabetes
• Interventions: Behavioral: Lifestyle counseling; Behavioral: Standard care

• Registration Number: NCT01085682
• Lead Sponsor: The Catholic University of Korea

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.

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 Timeline

• Study Start: 2008-01
• Study First Submitted: 2010-02-19
• Study First Submitted QC: 2010-03-11
• Study First Posted: 2010-03-12
• Primary Completion: 2013-11
• Study Completion: 2013-11
• Status Verified: 2014-09
• Results First Submitted: 2014-09-08
• Results First Submitted QC: 2014-09-08
• Last Update Submitted: 2014-09-08
• Results First Posted: 2014-09-12
• Last Update Posted: 2014-09-12

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 59

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Lifestyle counseling	Lifestyle counseling	-
Standard care	Standard care	-

Primary Outcome Measures

Name	Time	Method
Incidence of Type 2 Diabetes Mellitus	one year follow up	Incidence of type 2 diabetes mellitus

Trial Locations

Locations (1)

Chung-ju health care center; 🇰🇷 Chung-ju, Chungchungbook-do, Korea, Republic of