Family History of Type 2 Diabetes Clinical Trial
Official title:
PPP-Botnia Exercise Intervention 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.
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.
| Status | Completed |
| Enrollment | 290 |
| Est. completion date | August 2013 |
| Est. primary completion date | August 2008 |
| Accepts healthy volunteers | No |
| Gender | Both |
| Age group | 30 Years to 70 Years |
| Eligibility |
Inclusion Criteria: - poor physical fitness based on repeated walking test (UKK 2 km walking test) - non-diabetic Exclusion Criteria: - health problems complicating moderate physical training |
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Basic Science
| Country | Name | City | State |
|---|---|---|---|
| Finland | Folkhälsan Research Center | Helsinki |
| Lead Sponsor | Collaborator |
|---|---|
| Folkhälsan Researech Center | Department of Clinical Sciences, Lund University Diabetes Center, CRC, Lund University, Malmö, Sweden, Department of Social Services and Health Care, Jakobstad, Finland, Närpes Health Care Center, Närpes, Finland |
Finland,
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Other | changes in muscle strength | muscle strength will be followed by the method of one repetition maximum | will be measured before study and after 1 and 5 years | No |
| Primary | improvement in physical fitness | Fitness will be measured by a 2 km walking test, which is an indirect measure of oxygen uptake | will be measured at 1, 2,3 and 5 years | No |
| Secondary | changes in body composition | body composition will be measured as weight, waist, fat percentage | measured at 1, 2, 3 and 5 years | No |