Type 2 Diabetes MellitusNCT01051089
Effects of Lifestyle Modification on Metabolic Parameters in Type 2 Diabetic Patients
A study testing Lifestyle modification in people with Type 2 Diabetes Mellitus, run by Inha University Hospital at 1 site in South Korea.
Trial summary
The study is a randomized controlled study comparing the metabolic effect of a 3 month intensive lifestyle modification intervention in Korean type 2 diabetic patients. Read more about this study
- Who is it for?
- Ages 25 to 80 years
- Conditions the study is for
- Type 2 Diabetes Mellitus
- What is being tested?
- Lifestyle modification
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteSouth Korea
- Study dates
- Jun 2009to Dec 2010
- Phase
- Interventional
- Are there results?
- None posted in the registry
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 25 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- age 25 or older,
- type 2 diabetes mellitus,
- HbA1c 6.5-10% BMI 23 or higher.
Who cannot join
- type 1 diabetes,
- recent (within 3 months) cardiovascular event,
- severe hepatic or renal dysfunction,
- insulin use,
- glucocorticoid use.
Trial locations and contacts
1 site in 1 country.
South Korea1 site, 1 recruiting
- Recruiting
Inha University Hospital
Incheon
Moonsuk Nam, MD, PhD, 82-32-890-3689, namms@inha.ac.kr
Moonsuk Nam, MD, PhD
About this study
Official title: Effects of Lifestyle Modification Focusing on Exercise Intervention on Risk of Atherosclerosis and Metabolic Parameters in Type 2 Diabetic Patients
The study is a randomized controlled study comparing the metabolic effect of a 3 month intensive lifestyle modification intervention in Korean type 2 diabetic patients.
- Conditions
- Type 2 Diabetes Mellitus
- Being tested
- Lifestyle modification
- Keywords
- type 2 diabetes mellitus, lifestyle modification
- Medical subject headings
- Diabetes Mellitus, Type 2
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Lifestyle modificationBehavioural
Exercise and diet education
| Study group | Role | What they receive |
|---|---|---|
| Lifestyle modification | Experimental | supervised exercise with diet education Receives: Behavioral: Lifestyle modification |
| Control | No intervention | Control (ordinary care with usual education) |
What is being measured
The primary outcome is the main question the study is designed to answer.
HbA1c, serum adipokine levels
Measured: 3 months
Secondary outcomes (4)
Body composition
Measured: 3 months
Pulse wave velocity
Measured: 3 months
Insulin secretion and sensitivity
Measured: 3 months
VO2max
Measured: 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Jan 2010 (estimated)
- Study startJun 2009
- Primary completionDec 2010 (estimated)
- Study completionDec 2010 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Type 2 Diabetes MellitusStudies 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 N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Inha University Hospital
- Sponsor type
- University, hospital or other
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01051089
- Sponsor's protocol ID
- 2009-459
- Status last verified
- Jan 2010
- First submitted
- 15 Jan 2010
- Last updated
- 18 Jan 2010
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 18 Jan 2010. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Lifestyle Modification Focusing on Exercise Intervention on Risk of Atherosclerosis and Metabolic Parameters in Type 2 Diabetic Patients
- ClinicalTrials.gov ID
- NCT01051089
- Acronym / sponsor ID
- 2009-459
- Conditions
- Type 2 Diabetes Mellitus
- Keywords
- type 2 diabetes mellitus, lifestyle modification
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- Inha University HospitalUniversity, hospital or other
- Study start
- Jun 2009
- Primary completion
- Dec 2010 (estimated)
- Study completion
- Dec 2010 (estimated)
- First posted
- 18 Jan 2010 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The study is a randomized controlled study comparing the metabolic effect of a 3 month intensive lifestyle modification intervention in Korean type 2 diabetic patients.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Lifestyle modification | Experimental | Behavioral: Lifestyle modificationsupervised exercise with diet education |
| Control | No intervention | –Control (ordinary care with usual education) |
Who may qualify
- Ages
- 25 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- age 25 or older,
- type 2 diabetes mellitus,
- HbA1c 6.5-10% BMI 23 or higher.
Key exclusion criteria (5 listed)
- type 1 diabetes,
- recent (within 3 months) cardiovascular event,
- severe hepatic or renal dysfunction,
- insulin use,
- glucocorticoid use.
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 modificationExercise and diet education | Behavioural | Lifestyle modification |
Primary outcome
HbA1c, serum adipokine levels
Time frame: 3 months
4 secondary outcomes
Body composition
Time frame: 3 months
Pulse wave velocity
Time frame: 3 months
Insulin secretion and sensitivity
Time frame: 3 months
VO2max
Time frame: 3 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Jan 2010.
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Lifestyle modification in people with Type 2 Diabetes Mellitus, run by Inha University Hospital 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 3 inclusion and 5 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: status not confirmed, as of the sponsor's last update on 18 Jan 2010. 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.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
HbA1c, serum adipokine levels (time frame: 3 months). 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 18 Jan 2010.