Type 2 DiabetesPhase 4NCT01085682
Application and Effectiveness Analysis of Internet-based Diabetes Prevention Program
A Phase 4 study testing Lifestyle counseling in people with Type 2 Diabetes, run by The Catholic University of Korea at 1 site in South Korea.
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. Read more about this study
- Who is it for?
- Ages 30 to 69 yearsHealthy volunteers can take part
- Conditions the study is for
- Type 2 Diabetes
- What is being tested?
- Lifestyle counseling
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 59 participants
- Where
- 1 siteSouth Korea
- Study dates
- Jan 2008to Nov 2013
- Phase
- Phase 4
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 30 to 69 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- Diabetes at baseline
- Cardiovascular disease, cancer requiring treatment in the past 5 years, renal disease
- Unable to communicate with clinic staff, Pregnancy and childbearing
Trial locations and contacts
1 site in 1 country.
About this study
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.
Read the 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.
- Conditions
- Type 2 Diabetes
- Being tested
- Lifestyle counseling, Standard care
- Keywords
- Diabetes prevention, Lifestyle modification, Obesity, Impaired glucose tolerance, Diet, Physical activity
- Medical subject headings
- Diabetes Mellitus, Type 2, Obesity, Glucose Intolerance, Motor Activity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Lifestyle counselingBehavioural
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 careBehavioural
In standard care group, counseling sessions are conducted only 6 times for 4 years
| Study group | Role | What they receive |
|---|---|---|
| Lifestyle counseling | Active comparator | Not described Receives: Behavioral: Lifestyle counseling |
| Standard care | Active comparator | Not described Receives: Behavioral: Standard care |
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence of Type 2 Diabetes Mellitus
Incidence of type 2 diabetes mellitus
Measured: one year follow up
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Mar 2010 (estimated)
- Study startJan 2008
- Primary completionNov 2013
- Study completionNov 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Type 2 DiabetesStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 59 participants (actual)
Sponsor and investigators
- Lead sponsor
- The Catholic University of Korea
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Kun-Ho Yoon, The Catholic University of Korea
- Investigators
- Kun-Ho Yoon, M.D., Ph.D., Study director, Kangnam St.Mary's hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01085682
- Sponsor's protocol ID
- KCMC07OT255
- Status last verified
- Sep 2014
- First submitted
- 19 Feb 2010
- Last updated
- 12 Sep 2014
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 12 Sep 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Application and Effectiveness Analysis of Internet-based Diabetes Prevention Program
- ClinicalTrials.gov ID
- NCT01085682
- Acronym / sponsor ID
- KCMC07OT255
- Conditions
- Type 2 Diabetes
- Keywords
- Diabetes prevention, Lifestyle modification, Obesity, Impaired glucose tolerance, Diet, Physical activity
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 59 participants (actual)
- Lead sponsor
- The Catholic University of KoreaUniversity, hospital or other
- Study start
- Jan 2008
- Primary completion
- Nov 2013 (actual)
- Study completion
- Nov 2013 (actual)
- First posted
- 12 Mar 2010 (estimated)
- Results
- Posted 12 Sep 2014
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Lifestyle counseling | Active comparator | Behavioral: Lifestyle counseling |
| Standard care | Active comparator | Behavioral: Standard care |
Who may qualify
- Ages
- 30 to 69 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (3 listed)
- Diabetes at baseline
- Cardiovascular disease, cancer requiring treatment in the past 5 years, renal disease
- Unable to communicate with clinic staff, Pregnancy and childbearing
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Lifestyle counselingIn 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. | Behavioural | Lifestyle counseling |
| Standard careIn standard care group, counseling sessions are conducted only 6 times for 4 years | Behavioural | Standard care |
Primary outcome
Incidence of Type 2 Diabetes Mellitus
Time frame: one year follow up
Incidence of type 2 diabetes mellitus
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Sep 2014.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Related trials for Type 2 Diabetes
Recruiting
Clinical Study to Evaluate the Impact of the Accu-Chek SmartGuide CGM Solution on the Mean Change in Time in Range Compared With Self-Monitoring of Blood Glucose in Participants With Type 1 and Type 2 Diabetes Mellitus
Type 1 Diabetes Mellitus, Type 2 Diabetes Mellitus
Enrolling by invitation
MTM2MTG Pilot Ancillary Study
Diet, Healthy, HbA1c
Active, not recruiting
Metabolic and Inflammatory Outcomes of the Ketogenic Diet Comparing Saturated and Unsaturated Fat Sources
PreDiabetes, Diabetes Mellitus, Type 2
Not yet recruitingPhase 1/2
A Study Testing the Safety and Possible Benefits of an Ear Injection of a New Compound, Paliroden, in People With Type 2 Diabetes Who Have Difficulty Understanding Speech in Noisy Situations
Cochlear Synaptopathy
Not yet recruitingPhase 1
A Research Study to Check the Safety of NNC9836-0001 When Given to Healthy Participants and Participants With Type 2 Diabetes
Diabetes Mellitus, Type 2
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Kun-Ho Yoon, M.D., Ph.D. study director
Kangnam St.Mary's hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Lifestyle counseling in people with Type 2 Diabetes, run by The Catholic University of Korea at 1 site in South Korea.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 12 Sep 2014. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in South Korea. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 12 Sep 2014). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Incidence of Type 2 Diabetes Mellitus (time frame: one year follow up). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 12 Sep 2014.