Type 2 DiabetesDIAVIPNCT01834378
Diabetes Prevention in Clinical Practice.
A study testing Low intensity intervention and High intensity intervention. in people with Type 2 Diabetes, run by Göteborg University.
Trial summary
We randomize individuals with impaired glucose tolerance to one of three arms for degree of physical activity: 1. Continue with your current life style; 2. Ordinary life activities for increased physical activity; 3. Scheduled group activities for changed behavior. Read more about this study
- Who is it for?
- Ages 20 to 85 years
- Conditions the study is for
- Type 2 Diabetes
- What is being tested?
- Low intensity intervention and High intensity intervention.
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 96 participants
- Where
- No sites listed yet
- Study dates
- Oct 2009to Aug 2016
- 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 20 to 85 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Impaired glucose tolerance
- Age: 20-85yrs
Who cannot join
- Type2 diabetes
- Significant disease making life style changes unlikely to happen
- Unable to communicate in Swedish
About this study
Official title: Diabetes Prevention in Primary Health Care With Special Emphasis on Physical Activity.
We randomize individuals with impaired glucose tolerance to one of three arms for degree of physical activity: 1. Continue with your current life style; 2. Ordinary life activities for increased physical activity; 3. Scheduled group activities for changed behavior. The overall aim is to focus on change of physical activity and to keep other life style activities more or less unchanged (diet, smoking, etc) and the effect on metabolic variables.
- Conditions
- Type 2 Diabetes
- Being tested
- Low intensity intervention, High intensity intervention.
- Keywords
- diabetes, insulin resistance, exercise
- Medical subject headings
- Diabetes Mellitus, Type 2, Diabetes Mellitus, Insulin Resistance, Motor Activity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Low intensity interventionBehavioural
We administer, a pedometer and the participants receive a prescription on physical exercise.
High intensity intervention.Behavioural
We schedule group sessions for changes in behavior e.g. type of physical activity to prefer, barriers for change of life style etc.
| Study group | Role | What they receive |
|---|---|---|
| No intervention | No intervention | Not described |
| Low intensity intervention | Experimental | Not described Receives: Behavioral: Low intensity intervention |
| High intensity intervention | Experimental | Not described Receives: Behavioral: High intensity intervention. |
What is being measured
The primary outcome is the main question the study is designed to answer.
HOMA IR
Insulin resistance according to HOMA
Measured: 12 months after inclusion (baseline)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Apr 2013 (estimated)
- Study startOct 2009
- Primary completionAug 2016
- Study completionAug 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Type 2 DiabetesStudies of the same condition, open and under way.
- More trials run by Göteborg UniversityThe sponsor's other registered studies.
- 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
- 96 participants (actual)
Sponsor and investigators
- Lead sponsor
- Göteborg University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01834378
- Sponsor's protocol ID
- DIAVIP-1204
- Other IDs
- Swedish Research Council
- Acronym
- DIAVIP
- Status last verified
- Aug 2016
- First submitted
- 15 Apr 2013
- Last updated
- 23 Aug 2016
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 23 Aug 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Diabetes Prevention in Primary Health Care With Special Emphasis on Physical Activity.
- ClinicalTrials.gov ID
- NCT01834378
- Acronym / sponsor ID
- DIAVIP / DIAVIP-1204
- Conditions
- Type 2 Diabetes
- Keywords
- diabetes, insulin resistance, exercise
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 96 participants (actual)
- Lead sponsor
- Göteborg UniversityUniversity, hospital or other
- Study start
- Oct 2009
- Primary completion
- Aug 2016 (actual)
- Study completion
- Aug 2016 (actual)
- First posted
- 17 Apr 2013 (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.
We randomize individuals with impaired glucose tolerance to one of three arms for degree of physical activity: 1. Continue with your current life style; 2. Ordinary life activities for increased physical activity; 3. Scheduled group activities for changed behavior. The overall aim is to focus on change of physical activity and to keep other life style activities more or less unchanged (diet, smoking, etc) and the effect on metabolic variables.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| No intervention | No intervention | – |
| Low intensity intervention | Experimental | Behavioral: Low intensity intervention |
| High intensity intervention | Experimental | Behavioral: High intensity intervention. |
Who may qualify
- Ages
- 20 to 85 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Impaired glucose tolerance
- Age: 20-85yrs
Key exclusion criteria (3 listed)
- Type2 diabetes
- Significant disease making life style changes unlikely to happen
- Unable to communicate in Swedish
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 |
|---|---|---|
| Low intensity interventionWe administer, a pedometer and the participants receive a prescription on physical exercise. | Behavioural | Low intensity intervention |
| High intensity intervention.We schedule group sessions for changes in behavior e.g. type of physical activity to prefer, barriers for change of life style etc. | Behavioural | High intensity intervention |
Primary outcome
HOMA IR
Time frame: 12 months after inclusion (baseline)
Insulin resistance according to HOMA
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Aug 2016.
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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.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
A study testing Low intensity intervention and High intensity intervention. in people with Type 2 Diabetes, run by Göteborg University.
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 2 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 23 Aug 2016. Status can change between updates, so confirm with the study contact before making plans.
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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
HOMA IR (time frame: 12 months after inclusion (baseline)). 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 23 Aug 2016.