- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01920659
METAPREDICT: Developing Predictors of the Health Benefits of Exercise for Individuals (METAPREDICT)
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.
Study Overview
Status
Conditions
Intervention / Treatment
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 Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
Leicestershire
-
Loughborough, Leicestershire, United Kingdom, LE11 5TN
- Loughborough University
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- Sedentary behavior
- BMI over 27 (kg/m2) or fasting glucose consistent with WHO criteria for impaired glucose tolerance
Exclusion Criteria:
- Physical active
Study Plan
How is the study designed?
Design Details
- Primary Purpose: PREVENTION
- Allocation: RANDOMIZED
- Interventional Model: PARALLEL
- Masking: NONE
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
EXPERIMENTAL: High Intensity Training (HIT)
6 weeks of HIT, 3 times a week (3-5 1min on/off)
|
6 weeks of HIT, 3 times a week (3-5 1min on/off)
|
EXPERIMENTAL: REHIT
6 weeks of HIT, 3 times a week (20sec)
|
6 weeks 3 x week (20sec intervals)
|
NO_INTERVENTION: control
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Insulin Sensitivity
Time Frame: 2 years
|
Genomic methods and OGTT
|
2 years
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Physical Fitness
Time Frame: 2 years
|
VO2max
|
2 years
|
Collaborators and Investigators
Sponsor
Collaborators
Investigators
- Principal Investigator: James Timmons, Professor, Loughborough University
Publications and helpful links
Helpful Links
Study record dates
Study Major Dates
Study Start
Primary Completion (ACTUAL)
Study Completion (ACTUAL)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (ESTIMATE)
Study Record Updates
Last Update Posted (ESTIMATE)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- METAPREDICT FP7
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Physical Activity
-
Istinye UniversityCompletedPhysical Activity | Youth | Physical Activity Barriers | Physical Activity FacilitatorsTurkey
-
Istanbul Kültür UniversityWithdrawnPhysical Activity Level | Physical Activity Awareness
-
Georgetown UniversityUniversity of PennsylvaniaCompletedPhysical Activity | Motor ActivityUnited States
-
Assistance Publique - Hôpitaux de ParisTerminatedPhysical Activity | Physical DisabilityFrance
-
University of Colorado, DenverCompletedPhysical Activity | Physical ImpairmentUnited States
-
PXL University CollegeHasselt UniversityNot yet recruitingPhysical Activity - Digital Phenotyping - Activity Tracking
-
University of ExtremaduraThe Spanish Ministry of Science, Innovation and UniversitiesRecruitingPhysical Activity | Cognition | Physical Fitness | AdolescentsSpain
-
AdventHealth Translational Research InstituteWake Forest UniversityRecruiting
-
Wake Forest University Health SciencesMayo Clinic; National Institute of Diabetes and Digestive and Kidney Diseases... and other collaboratorsRecruitingPhysical ActivityUnited States
-
Wake Forest University Health SciencesMayo Clinic; National Institute of Diabetes and Digestive and Kidney Diseases... and other collaboratorsRecruiting
Clinical Trials on High Intensity Training (HIT)
-
Haukeland University HospitalRecruitingBipolar Disorder | Schizophrenia and Related DisordersNorway
-
University of BaselClinical Trial Unit, University Hospital Basel, SwitzerlandRecruitingHigh-intensity Interval Training in Heart Failure Patients With Preserved Ejection Fraction (HIT-HF)Heart Failure With Normal Ejection FractionSwitzerland
-
University of NottinghamCompletedHigh-Intensity Interval TrainingUnited Kingdom
-
Hasselt UniversityJessa HospitalUnknown
-
University of CincinnatiChildren's Hospital Medical Center, Cincinnati; American Physical Therapy AssociationCompleted
-
St. Olavs HospitalNorwegian University of Science and TechnologyCompletedDepressive Disorder | Depressive Disorder, MajorNorway
-
Norwegian University of Science and TechnologySt. Olavs HospitalRecruiting
-
University of Castilla-La ManchaMinisterio de Economía y Competitividad, Spain; Biomedical Research Networking...CompletedFrail Elderly Syndrome | Sarcopenia | AgingSpain
-
Indiana UniversityNational Institute of Neurological Disorders and Stroke (NINDS); Rehabilitation...Recruiting
-
Western University, CanadaCompleted