Insulin SensitivityMETAPREDICTNCT01920659
METAPREDICT: Developing Predictors of the Health Benefits of Exercise for Individuals
A study testing High Intensity Training (HIT) and REHIT in people with Insulin Sensitivity and Physical Activity, run by Loughborough University at 1 site in United Kingdom.
Trial summary
Physical activity is a powerful lifestyle factor that on average reduces risk for development of diabetes and cardiovascular disease. Nevertheless, investigators have demonstrated that following supervised endurance exercise training, 20% of subjects show no change in fitness and 30% demonstrate no improvement in… Read more about this study
- Who is it for?
- Ages 18 to 55 yearsHealthy volunteers can take part
- Conditions the study is for
- Insulin Sensitivity, Physical Activity
- What is being tested?
- High Intensity Training (HIT) and REHIT
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 188 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- Apr 2012to Oct 2014
- 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 18 to 55 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Sedentary behavior
- BMI over 27 (kg/m2) or fasting glucose consistent with WHO criteria for impaired glucose tolerance
Who cannot join
- Physical active
Trial locations and contacts
1 site in 1 country.
United Kingdom1 site
Loughborough University
Loughborough, Leicestershire, LE11 5TN
About this study
Official title: Developing Predictors of the Health Benefits of Exercise for Individuals
Physical activity is a powerful lifestyle factor that on average reduces risk for development of diabetes and cardiovascular disease. Nevertheless, investigators have demonstrated that following supervised endurance exercise training, 20% of subjects show no change in fitness and 30% demonstrate no improvement in insulin sensitivity.
Our concept is that by using molecular profiling of blood/muscle samples investigators will develop personalised lifestyle intervention tools. Further, revealing the biological basis for a variable metabolic or cardiovascular response to exercise will enable us to propose new targets and biomarkers for drug discovery efforts directly in humans. Using our established OMICS approaches (RNA, DNA and Metabo-) investigators will generate classifiers that predict the responses to exercise-therapy (fitness and insulin sensitivity). Classifier generation is a statistical strategy for diagnosis or prognosis. Critically, investigators have a large human tissue biobank, including subjects with insulin-resistance; young to elderly males and females, as well as twins. Our SME partner has significant intellectual property and capacity in the field of bio-prediction, with a proven track-record of collaboration with the team and product development. Investigators will add to the diversity of our biobank by carrying-out an exercise intervention study using a novel time-efficient strategy that investigators have recently proven to be effective in reducing insulin resistance in sedentary young people and in middle aged obese subjects. A time-efficient protocol is a critical as lack-of-time is a key reason for not maintaining physical activity levels. Finally, investigators have a novel out-bred rodent model that replicates high and low exercise training responses and investigators will establish its suitability for future drug screening purposes. Because of these substantial pre-existing resources investigators believe that our project has a very high probability of delivering on its goals of improving the healthcare of European citizens.
Read the detailed description
Aerobic exercise capacity, in prospective follow-up analyses, is a stronger a predictor of morbidity and mortality than other recognised risk factors such as hypertension. Furthermore, the most powerful lifestyle factor that on average reduces the risk for development of Type II diabetes is arguably increased physical activity. Investigators have clearly demonstrated that following many weeks of supervised aerobic exercise training ~20% of sedentary volunteers show almost no changes in gold standard measurements of fitness and many more demonstrate a poor response. Furthermore at least 25% of people demonstrate no improvement in insulin sensitivity in response to aerobic training. Critically, 15% of all subjects undergoing a supervised exercise intervention programme (with full compliance) actually demonstrated a decline in their insulin sensitivity after exercise training. Extensive citations were provided in the original grant application documents.
A major aim of this project is to identify genomic or molecular predictors for this lack of positive benefit ('non-responder'), so that individualised health care strategies and life style changes can be produced to fight or prevent metabolic diseases such as obesity, diabetes and cardiovascular disease. Identification of 'high responders' to physical training forms an additional positive outcome from our research program. Understanding the biological basis for our 'highest-responders' will provide enormous insight into the molecular basis for positive exercise adaptation and a number of important health and industry related opportunities. For example, knowledge that a patient is a high-responder could be used to encourage cardiacfailure patients to remain motivated during their rehabilitation. Knowledge that a patient was a low responder would enable clinicians to set proper expectations during rehabilitation.
Finally, as part of our research plan investigators will establish the utility of a novel time-efficient lifestyle strategy that has a high potential for being integrated into modern life.
Investigators bring together leading EU and North American investigators to study life-style determinants of diabetes, obesity and cardiovascular disease. In particular, our workpackages are focused on boosting the capacity to diagnose, develop drug-screening solutions and enable the application of personalised medicine to the field of life-style determinants of diabetes, obesity and cardiovascular disease. Our deliverables include new validated products which can define higher risk populations. Investigators will achieve this through the identification and validation of molecular predictors that quantify the extent of the health benefits of increased physical activity. Optimisation of the prescription of physical activity for the treatment of insulin resistance, will contribute to the long term prevention of diabetic complications.
- Conditions
- Insulin Sensitivity, Physical Activity
- Being tested
- High Intensity Training (HIT), REHIT
- Keywords
- High Intensity Training, Insulin sensitivity, Fitness
- Medical subject headings
- Insulin Resistance, Motor Activity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
High Intensity Training (HIT)Behavioural
6 weeks of HIT, 3 times a week (3-5 1min on/off)
REHITBehavioural
6 weeks 3 x week (20sec intervals)
| Study group | Role | What they receive |
|---|---|---|
| High Intensity Training (HIT) | Experimental | 6 weeks of HIT, 3 times a week (3-5 1min on/off) Receives: Behavioral: High Intensity Training (HIT) |
| REHIT | Experimental | 6 weeks of HIT, 3 times a week (20sec) Receives: Behavioral: REHIT |
| control | No intervention | control |
What is being measured
The primary outcome is the main question the study is designed to answer.
Insulin Sensitivity
Genomic methods and OGTT
Measured: 2 years
Secondary outcomes (1)
Physical Fitness
VO2max
Measured: 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Aug 2013 (estimated)
- Study startApr 2012
- Primary completionApr 2014
- Study completionOct 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Insulin SensitivityStudies 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
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 188 participants (actual)
Sponsor and investigators
- Lead sponsor
- Loughborough University
- Sponsor type
- University, hospital or other
- Collaborators
- University of Nottingham, Medical Prognosis Institute A/S, Karolinska Institutet, University of Copenhagen, University of Las Palmas Spain, Duke University
- Responsible party
- Principal investigator, Professor James Timmons, King's College London
- Investigators
- James Timmons, Professor, Principal investigator, Loughborough University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01920659
- Sponsor's protocol ID
- METAPREDICT FP7
- Acronym
- METAPREDICT
- Status last verified
- Dec 2014
- First submitted
- 8 Aug 2013
- Last updated
- 3 Dec 2014
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 3 Dec 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Developing Predictors of the Health Benefits of Exercise for Individuals
- ClinicalTrials.gov ID
- NCT01920659
- Acronym / sponsor ID
- METAPREDICT / METAPREDICT FP7
- Conditions
- Insulin Sensitivity, Physical Activity
- Keywords
- High Intensity Training, Insulin sensitivity, Fitness
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 188 participants (actual)
- Lead sponsor
- Loughborough UniversityUniversity, hospital or other
- Collaborators
- University of Nottingham, Medical Prognosis Institute A/S, Karolinska Institutet, University of Copenhagen, University of Las Palmas Spain, Duke University
- Study start
- Apr 2012
- Primary completion
- Apr 2014 (actual)
- Study completion
- Oct 2014 (actual)
- First posted
- 12 Aug 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.
Physical activity is a powerful lifestyle factor that on average reduces risk for development of diabetes and cardiovascular disease. Nevertheless, investigators have demonstrated that following supervised endurance exercise training, 20% of subjects show no change in fitness and 30% demonstrate no improvement in insulin sensitivity.
Our concept is that by using molecular profiling of blood/muscle samples investigators will develop personalised lifestyle intervention tools. Further, revealing the biological basis for a variable metabolic or cardiovascular response to exercise will enable us to propose new targets and biomarkers for drug discovery efforts directly in humans. Using our established OMICS approaches (RNA, DNA and Metabo-) investigators will generate classifiers that predict the responses to exercise-therapy (fitness and insulin sensitivity). Classifier generation is a statistical strategy for diagnosis or prognosis. Critically, investigators have a large human tissue biobank, including subjects with insulin-resistance; young to elderly males and females, as well as twins. Our SME partner has significant intellectual property and capacity in the field of bio-prediction, with a proven track-record of collaboration with the team and product development. Investigators will add to the diversity of our biobank by carrying-out an exercise intervention study using a novel time-efficient strategy that investigators have recently proven to be effective in reducing insulin resistance in sedentary young people and in middle aged obese subjects. A time-efficient protocol is a critical as lack-of-time is a key reason for not maintaining physical activity levels. Finally, investigators have a novel out-bred rodent model that replicates high and low exercise training responses and investigators will establish its suitability for future drug screening purposes. Because of these substantial pre-existing resources investigators believe that our project has a very high probability of delivering on its goals of improving the healthcare of European citizens.
Detailed description
Aerobic exercise capacity, in prospective follow-up analyses, is a stronger a predictor of morbidity and mortality than other recognised risk factors such as hypertension. Furthermore, the most powerful lifestyle factor that on average reduces the risk for development of Type II diabetes is arguably increased physical activity. Investigators have clearly demonstrated that following many weeks of supervised aerobic exercise training ~20% of sedentary volunteers show almost no changes in gold standard measurements of fitness and many more demonstrate a poor response. Furthermore at least 25% of people demonstrate no improvement in insulin sensitivity in response to aerobic training. Critically, 15% of all subjects undergoing a supervised exercise intervention programme (with full compliance) actually demonstrated a decline in their insulin sensitivity after exercise training. Extensive citations were provided in the original grant application documents.
A major aim of this project is to identify genomic or molecular predictors for this lack of positive benefit ('non-responder'), so that individualised health care strategies and life style changes can be produced to fight or prevent metabolic diseases such as obesity, diabetes and cardiovascular disease. Identification of 'high responders' to physical training forms an additional positive outcome from our research program. Understanding the biological basis for our 'highest-responders' will provide enormous insight into the molecular basis for positive exercise adaptation and a number of important health and industry related opportunities. For example, knowledge that a patient is a high-responder could be used to encourage cardiacfailure patients to remain motivated during their rehabilitation. Knowledge that a patient was a low responder would enable clinicians to set proper expectations during rehabilitation.
Finally, as part of our research plan investigators will establish the utility of a novel time-efficient lifestyle strategy that has a high potential for being integrated into modern life.
Investigators bring together leading EU and North American investigators to study life-style determinants of diabetes, obesity and cardiovascular disease. In particular, our workpackages are focused on boosting the capacity to diagnose, develop drug-screening solutions and enable the application of personalised medicine to the field of life-style determinants of diabetes, obesity and cardiovascular disease. Our deliverables include new validated products which can define higher risk populations. Investigators will achieve this through the identification and validation of molecular predictors that quantify the extent of the health benefits of increased physical activity. Optimisation of the prescription of physical activity for the treatment of insulin resistance, will contribute to the long term prevention of diabetic complications.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| High Intensity Training (HIT) | Experimental | Behavioral: High Intensity Training (HIT)6 weeks of HIT, 3 times a week (3-5 1min on/off) |
| REHIT | Experimental | Behavioral: REHIT6 weeks of HIT, 3 times a week (20sec) |
| control | No intervention | –control |
Who may qualify
- Ages
- 18 to 55 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (2 listed)
- Sedentary behavior
- BMI over 27 (kg/m2) or fasting glucose consistent with WHO criteria for impaired glucose tolerance
Key exclusion criteria (1 listed)
- Physical active
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 |
|---|---|---|
| High Intensity Training (HIT)6 weeks of HIT, 3 times a week (3-5 1min on/off) | Behavioural | High Intensity Training (HIT) |
| REHIT6 weeks 3 x week (20sec intervals) | Behavioural | REHIT |
Primary outcome
Insulin Sensitivity
Time frame: 2 years
Genomic methods and OGTT
1 secondary outcome
Physical Fitness
Time frame: 2 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 3 Dec 2014.
- Webpage for the METAPREDICT studyLink provided by the sponsor.
Related trials for Insulin Sensitivity
Active, not recruiting
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Trial of the Combination of Alpha-Lipoic Acid and Mirabegron in Women and in Men With Obesity
Insulin Resistance, Obesity
Recruiting
Improving Sleep Health and Circadian Timing to Support Cardiometabolic Health in Adolescents
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Not yet recruitingObservational study
Clinical Research Trial to Study Insulin Sensitivity Using Automated Glucose Clamp Technology
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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.
James Timmons, Professor principal investigator
Loughborough University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing High Intensity Training (HIT) and REHIT in people with Insulin Sensitivity and Physical Activity, run by Loughborough University at 1 site in United Kingdom.
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 3 Dec 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 United Kingdom. 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?
Insulin Sensitivity (time frame: 2 years). 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 3 Dec 2014.