Application and Effectiveness Analysis of Internet-based Diabetes Prevention Program

Type 2 Diabetes Clinical Trial

Official title:

Application and Effectiveness Analysis of Internet-based Diabetes Prevention Program

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01085682
• Other study ID #: KCMC07OT255
• Status: Completed
• Phase: Phase 4
• First received: February 19, 2010
• Last updated: September 8, 2014
• Start date: January 2008
• Est. completion date: November 2013

Study information

• Verified date: September 2014
• Source: The Catholic University of Korea
• Contact: n/a
• Is FDA regulated: No
• Health authority: South Korea: Institutional Review Board
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 59
• Est. completion date: November 2013
• Est. primary completion date: November 2013
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 30 Years to 69 Years

Eligibility

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

Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Prevention

Related Conditions & MeSH terms

• Type 2 Diabetes

Intervention

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

Locations

Country	Name	City	State
Korea, Republic of	Chung-ju health care center	Chung-ju	Chungchungbook-do

Sponsors (1)

Lead Sponsor	Collaborator
The Catholic University of Korea

Country where clinical trial is conducted

Korea, Republic of, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Incidence of Type 2 Diabetes Mellitus	Incidence of type 2 diabetes mellitus	one year follow up	No