PrediabetesPhase 4PreDiabExNCT01649219
Intensity of Exercise and Glucose Metabolism
A Phase 4 study testing Exercise in people with Prediabetes, run by University of Oulu at 1 site in Finland.
Trial summary
Our aim is to investigate the effects of a 12-week structured aerobic exercise on fasting and 2 h glucose, insulin and lipid concentrations in sedentary overweight subjects in whom impaired fasting glucose and/or impaired glucose tolerance was observed for the first time. Read more about this study
- Who is it for?
- Ages 30 to 70 years
- Conditions the study is for
- Prediabetes
- What is being tested?
- Exercise
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 80 participants
- Where
- 1 siteFinland
- Study dates
- Jan 2010to Jun 2013
- Phase
- Phase 4
- 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
- prediabetes determined by 2 hr oGTT
Who cannot join
- any functional limitation or chronic disease that might have limited the physical exercise and testing
- vigorous physical activity/exercise as revealed by questionnaire and physician exam
Trial locations and contacts
1 site in 1 country.
About this study
Our aim is to investigate the effects of a 12-week structured aerobic exercise on fasting and 2 h glucose, insulin and lipid concentrations in sedentary overweight subjects in whom impaired fasting glucose and/or impaired glucose tolerance was observed for the first time.
Read the detailed description
Study type: Interventional
Study design: Randomized
Endpoint classification: Changes in fasting and 2 h glucose, insulin and lipid concentrations
Intervention model: Parallel assignment
Masking: Open label
Primary purpose: Prevention and dose response assessment of exercise on glucose and lipid metabolism
Condition: Prediabetes
Intervention: Supervised exercise - The training sessions of the intervention group are carried out indoors 3 times a week for 3 months and supervised by an exercise instructor and physician. Each session last for 60 min and include a 5-min warm-up and stretching, a 20-min walking at speeds 2-4 km/h depending of the participant's physical condition, a 5-min stretching and balance training, a 20-min walking, and a 10-min stretching and balance training. After 1.5 months the 5-min stretching and balance training between the two 20-min walkings is excluded, and the walking time become 45 min.
No intervention: control group; couseling at baseline. Participants of the control group are advised to continue their usual physical and dietary habits.
Experimental: 1 -supervised exercise intervention. No intervention: 2 - standard counseling at baseline.
- Conditions
- Prediabetes
- Being tested
- Exercise
- Keywords
- Prediabetes, objectively measured exercise, glucose and lipid metabolism, dose response, muscle metabolism.
- Medical subject headings
- Prediabetic State
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ExerciseBehavioural
| Study group | Role | What they receive |
|---|---|---|
| Exercise intervention | Experimental | 3-month supervised exercise intervention 3 times per week; 60min per time. Receives: Behavioral: Exercise |
| No intervention | No intervention | Standard couselling at baseline |
What is being measured
The primary outcome is the main question the study is designed to answer.
Glucose and lipid metabolism
Measured: 3-month intervention
Secondary outcomes (1)
Changes in muscle metabolism
Measured: 3-months intervention
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Jul 2012 (estimated)
- Study startJan 2010
- Primary completionJun 2010
- Study completionJun 2013 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for PrediabetesStudies 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
- 80 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Oulu
- Sponsor type
- University, hospital or other
- Collaborators
- Finnish Diabetes Association, Oulu University Hospital
- Responsible party
- Sponsor
- Investigators
- Karl-Heinz Herzig, MD,PhD, Principal investigator, University of Oulu
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01649219
- Sponsor's protocol ID
- 64/2009
- Acronym
- PreDiabEx
- Status last verified
- Jul 2012
- First submitted
- 21 Jul 2012
- Last updated
- 25 Jul 2012
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 25 Jul 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Intensity of Exercise and Glucose Metabolism
- ClinicalTrials.gov ID
- NCT01649219
- Acronym / sponsor ID
- PreDiabEx / 64/2009
- Conditions
- Prediabetes
- Keywords
- Prediabetes, objectively measured exercise, glucose and lipid metabolism, dose response, muscle metabolism.
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 80 participants (actual)
- Lead sponsor
- University of OuluUniversity, hospital or other
- Collaborators
- Finnish Diabetes Association, Oulu University Hospital
- Study start
- Jan 2010
- Primary completion
- Jun 2010 (actual)
- Study completion
- Jun 2013 (estimated)
- First posted
- 25 Jul 2012 (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.
Our aim is to investigate the effects of a 12-week structured aerobic exercise on fasting and 2 h glucose, insulin and lipid concentrations in sedentary overweight subjects in whom impaired fasting glucose and/or impaired glucose tolerance was observed for the first time.
Detailed description
Study type: Interventional
Study design: Randomized
Endpoint classification: Changes in fasting and 2 h glucose, insulin and lipid concentrations
Intervention model: Parallel assignment
Masking: Open label
Primary purpose: Prevention and dose response assessment of exercise on glucose and lipid metabolism
Condition: Prediabetes
Intervention: Supervised exercise - The training sessions of the intervention group are carried out indoors 3 times a week for 3 months and supervised by an exercise instructor and physician. Each session last for 60 min and include a 5-min warm-up and stretching, a 20-min walking at speeds 2-4 km/h depending of the participant's physical condition, a 5-min stretching and balance training, a 20-min walking, and a 10-min stretching and balance training. After 1.5 months the 5-min stretching and balance training between the two 20-min walkings is excluded, and the walking time become 45 min.
No intervention: control group; couseling at baseline. Participants of the control group are advised to continue their usual physical and dietary habits.
Experimental: 1 -supervised exercise intervention. No intervention: 2 - standard counseling at baseline.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Exercise intervention | Experimental | Behavioral: Exercise3-month supervised exercise intervention 3 times per week; 60min per time. |
| No intervention | No intervention | –Standard couselling at baseline |
Who may qualify
- Ages
- 30 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- prediabetes determined by 2 hr oGTT
Key exclusion criteria (2 listed)
- any functional limitation or chronic disease that might have limited the physical exercise and testing
- vigorous physical activity/exercise as revealed by questionnaire and physician exam
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 |
|---|---|---|
| Exercise | Behavioural | Exercise intervention |
Primary outcome
Glucose and lipid metabolism
Time frame: 3-month intervention
1 secondary outcome
Changes in muscle metabolism
Time frame: 3-months intervention
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Jul 2012.
Related trials for Prediabetes
Recruiting
Effects of Lean Pork Loin Intake on Protein Homeostasis and Glucose Regulation in Prediabetic Adults
Hyperglycaemia (Non Diabetic), Prediabetes
RecruitingObservational study
Food-i-Sense Analytics: Integrating AI Into Continuous Glucose Monitoring Data Analysis for Precision Nutrition.
Prediabetes (Insulin Resistance, Impaired Glucose Tolerance), Artificial Intelligence Mobile Application
RecruitingPhase 3
A Study of Orforglipron in Participants With Overweight at Risk of Development of Obesity-Related Complications or Progression to Class 1 Obesity
Overweight, Prediabetic State
Enrolling by invitationEarly Phase 1
Truway Diagnostic Tools in Primary Care
Chronic Disease, Type 2 Diabetes Mellitus (T2DM), Obesity, Overweight
Recruiting
CGM-Enhanced DPP to Prevent Type 2 Diabetes in Adults With Prediabetes
PreDiabetes
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.
Karl-Heinz Herzig, MD,PhD principal investigator
University of Oulu
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 Exercise in people with Prediabetes, run by University of Oulu 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 1 inclusion and 2 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 25 Jul 2012. 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.
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?
Results are not available in the source record.
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?
Glucose and lipid metabolism (time frame: 3-month intervention). 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 25 Jul 2012.