Type 2 Diabetes
Conditions
Keywords
Diabetes prevention, Lifestyle modification, Obesity, Impaired glucose tolerance, Diet, Physical activity
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.
Interventions
BEHAVIORALLifestyle 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.
BEHAVIORALStandard care
In standard care group, counseling sessions are conducted only 6 times for 4 years
Sponsors
The Catholic University of Korea
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
30 Years to 69 Years
Healthy volunteers
Yes
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Incidence of Type 2 Diabetes Mellitus | one year follow up | Incidence of type 2 diabetes mellitus |
Countries
South Korea
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| 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. | 6 |
| Standard Care Standard care: In standard care group, counseling sessions are conducted only 6 times for 4 years | 3 |
| Total | 9 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Overall Study | Withdrawal by Subject | 25 | 25 |
Baseline characteristics
| Characteristic | Lifestyle Counseling | Standard Care | Total |
|---|---|---|---|
| Age, Continuous | 55 years STANDARD_DEVIATION 3 | 55 years STANDARD_DEVIATION 3 | 55 years STANDARD_DEVIATION 3 |
| Sex: Female, Male Female | 2 Participants | 1 Participants | 3 Participants |
| Sex: Female, Male Male | 4 Participants | 2 Participants | 6 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — |
| other Total, other adverse events | 0 / 0 | 0 / 0 |
| serious Total, serious adverse events | 0 / 0 | 0 / 0 |
Outcome results
Primary
Incidence of Type 2 Diabetes Mellitus
Incidence of type 2 diabetes mellitus
Time frame: one year follow up
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Lifestyle Counseling | Incidence of Type 2 Diabetes Mellitus | 1 participants |
| Standard Care | Incidence of Type 2 Diabetes Mellitus | 1 participants |