Family History of Type 2 DiabetesNCT02131701
PPP-Botnia Exercise Intervention Study
A study testing Physical activity in people with Family History of Type 2 Diabetes, run by Folkhälsan Researech Center at 1 site in Finland.
Trial summary
The aim of the study is to evaluate the long-term effects of a prescription of exercise versus a group-based training program on aerobic fitness, muscle strength and metabolic variables in subjects with poor physical fitness. The participants are further stratified for a family-history of type 2 diabetes. Read more about this study
- Who is it for?
- Ages 30 to 70 years
- Conditions the study is for
- Family History of Type 2 Diabetes
- What is being tested?
- Physical activity
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 290 participants
- Where
- 1 siteFinland
- Study dates
- Oct 2006to Aug 2013
- 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 30 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- poor physical fitness based on repeated walking test (UKK 2 km walking test)
- non-diabetic
Who cannot join
- health problems complicating moderate physical training
Trial locations and contacts
1 site in 1 country.
About this study
The aim of the study is to evaluate the long-term effects of a prescription of exercise versus a group-based training program on aerobic fitness, muscle strength and metabolic variables in subjects with poor physical fitness. The participants are further stratified for a family-history of type 2 diabetes. The number of subjects in each group of intervention is planned to be 150, aged 30-70 years and non-diabetic.
Intervention: All study subjects take part in two individual sessions for exercise prescription aiming at moderate exercise of 30 minutes at least 5 days a week. The prescription group perform exercise by themselves, while the training group will be offered supervised physical training, including both endurance training and training in gym twice a week during 12 months.
Read more
The subjects will be followed up at 1, 2, 3 and 5 years after the basal visit.
Methods of follow-up: At the study visits physical fitness will be measured by a 2 km walking test, glucose tolerance by oral glucose tolerance test with measurement of glucose and insulin. Lipids will be measured. Questionnaires will be used to follow lifestyle, physical activity, cardiovascular disease and medication.
In the training group 30 subjects with and 30 subjects without a family history of type 2 diabetes will participate in a sub-study including muscle- and fat-biopsy before the start of the study, after 1 and 5 years.
- Conditions
- Family History of Type 2 Diabetes
- Being tested
- Physical activity
- Keywords
- Physical fitness, Family history of type 2 diabetes, Prescription of exercise
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Physical activityBehavioural
| Study group | Role | What they receive |
|---|---|---|
| Training group | Active comparator | The training group received individualized information about moderate training and was also offered training in group twice a week during 12 months. The training included both endurance training (nordic walking, water gymnastics) and training in gym. Receives: Behavioral: Physical activity |
| Prescription of exercise | Active comparator | Individualized sessions for exercise prescription aiming at moderate exercise of 30 minutes at least 5 days a week Receives: Behavioral: Physical activity |
What is being measured
The primary outcome is the main question the study is designed to answer.
improvement in physical fitness
Fitness will be measured by a 2 km walking test, which is an indirect measure of oxygen uptake
Measured: will be measured at 1, 2,3 and 5 years
Secondary outcomes (1)
changes in body composition
body composition will be measured as weight, waist, fat percentage
Measured: measured at 1, 2, 3 and 5 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 May 2014 (estimated)
- Study startOct 2006
- Primary completionAug 2008
- Study completionAug 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Family History of 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 N/A
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 290 participants (actual)
Sponsor and investigators
- Lead sponsor
- Folkhälsan Researech Center
- Sponsor type
- University, hospital or other
- Collaborators
- Närpes Health Care Center, Närpes, Finland, Department of Social Services and Health Care, Jakobstad, Finland, Department of Clinical Sciences, Lund University Diabetes Center, CRC, Lund University, Malmö, Sweden
- Responsible party
- Sponsor
- Investigators
- Bo Isomaa, MD, Principal investigator, Folkhälsan Research Center, Helsinki, Finland
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02131701
- Sponsor's protocol ID
- PPP2007
- Status last verified
- May 2014
- First submitted
- 4 May 2014
- Last updated
- 6 May 2014
- Results posted
- No
- Data monitoring committee
- No
Publications
Wasenius NS, Isomaa BA, Ostman B, Soderstrom J, Forsen B, Lahti K, Hakaste L, Eriksson JG, Groop L, Hansson O, Tuomi T. Low-cost exercise interventions improve long-term cardiometabolic health independently of a family history of type 2 diabetes: a randomized parallel group trial. BMJ Open Diabetes Res Care. 2020 Nov;8(2):e001377. doi: 10.1136/bmjdrc-2020-001377.
PubMed 33219117
Study at a glance
From the registry record, last updated by the sponsor on 6 May 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- PPP-Botnia Exercise Intervention Study
- ClinicalTrials.gov ID
- NCT02131701
- Acronym / sponsor ID
- PPP2007
- Conditions
- Family History of Type 2 Diabetes
- Keywords
- Physical fitness, Family history of type 2 diabetes, Prescription of exercise
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 290 participants (actual)
- Lead sponsor
- Folkhälsan Researech CenterUniversity, hospital or other
- Collaborators
- Närpes Health Care Center, Närpes, Finland, Department of Social Services and Health Care, Jakobstad, Finland, Department of Clinical Sciences, Lund University Diabetes Center, CRC, Lund University, Malmö, Sweden
- Study start
- Oct 2006
- Primary completion
- Aug 2008 (actual)
- Study completion
- Aug 2013 (actual)
- First posted
- 6 May 2014 (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 aim of the study is to evaluate the long-term effects of a prescription of exercise versus a group-based training program on aerobic fitness, muscle strength and metabolic variables in subjects with poor physical fitness. The participants are further stratified for a family-history of type 2 diabetes. The number of subjects in each group of intervention is planned to be 150, aged 30-70 years and non-diabetic.
Intervention: All study subjects take part in two individual sessions for exercise prescription aiming at moderate exercise of 30 minutes at least 5 days a week. The prescription group perform exercise by themselves, while the training group will be offered supervised physical training, including both endurance training and training in gym twice a week during 12 months.
The subjects will be followed up at 1, 2, 3 and 5 years after the basal visit.
Methods of follow-up: At the study visits physical fitness will be measured by a 2 km walking test, glucose tolerance by oral glucose tolerance test with measurement of glucose and insulin. Lipids will be measured. Questionnaires will be used to follow lifestyle, physical activity, cardiovascular disease and medication.
In the training group 30 subjects with and 30 subjects without a family history of type 2 diabetes will participate in a sub-study including muscle- and fat-biopsy before the start of the study, after 1 and 5 years.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Training group | Active comparator | Behavioral: Physical activityThe training group received individualized information about moderate training and was also offered training in group twice a week during 12 months. The training included both endurance training (nordic walking, water gymnastics) and training in gym. |
| Prescription of exercise | Active comparator | Behavioral: Physical activityIndividualized sessions for exercise prescription aiming at moderate exercise of 30 minutes at least 5 days a week |
Who may qualify
- Ages
- 30 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- poor physical fitness based on repeated walking test (UKK 2 km walking test)
- non-diabetic
Key exclusion criteria (1 listed)
- health problems complicating moderate physical training
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 |
|---|---|---|
| Physical activity | Behavioural | Prescription of exercise, Training group |
Primary outcome
improvement in physical fitness
Time frame: will be measured at 1, 2,3 and 5 years
Fitness will be measured by a 2 km walking test, which is an indirect measure of oxygen uptake
1 secondary outcome
changes in body composition
Time frame: measured at 1, 2, 3 and 5 years
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 6 May 2014.
- Derived from this study: PubMed 33219117Wasenius NS, Isomaa BA, Ostman B, Soderstrom J, Forsen B, Lahti K, Hakaste L, Eriksson JG, Groop L, Hansson O, Tuomi T. Low-cost exercise interventions improve long-term cardiometabolic health independently of a family history of type 2 diabetes: a randomized parallel group trial. BMJ Open Diabetes Res Care. 2020 Nov;8(2):e001377. doi: 10.1136/bmjdrc-2020-001377.
Related trials for Family History of Type 2 Diabetes
RecruitingObservational study
Rare Disease Patient Registry & Natural History Study - Coordination of Rare Diseases at Sanford
Rare Disorders, Undiagnosed Disorders
Not yet recruitingPhase 2/3
Diabetes Prevention Through Genetics, Familial History and Behavior Change
Prediabetes, Weight Loss
Active, not recruitingObservational study
Family Investigation of Nephropathy and Diabetes (F.I.N.D.)
Diabetic Nephropathy, Diabetes Mellitus
RecruitingObservational study
Growth Hormone Resistance of Beta-cells in People With a Family History of Type 2 Diabetes
Healthy, Obesity
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.
Bo Isomaa, MD principal investigator
Folkhälsan Research Center, Helsinki, Finland
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Physical activity in people with Family History of Type 2 Diabetes, run by Folkhälsan Researech Center at 1 site in Finland.
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 1 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 6 May 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 Finland. 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?
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?
improvement in physical fitness (time frame: will be measured at 1, 2,3 and 5 years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02131701, which also lists 1 linked publication.
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 6 May 2014.