METAPREDICT: Developing Predictors of the Health Benefits of Exercise for Individuals

NCT01920659 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 188

Last updated 2014-12-03

No results posted yet for this study

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 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.

Conditions

  • Insulin Sensitivity
  • Physical Activity

Interventions

BEHAVIORAL

High Intensity Training (HIT)

6 weeks of HIT, 3 times a week (3-5 1min on/off)

BEHAVIORAL

REHIT

6 weeks 3 x week (20sec intervals)

Sponsors & Collaborators

  • University of Nottingham

    collaborator OTHER
  • Medical Prognosis Institute A/S

    collaborator INDUSTRY
  • Karolinska Institutet

    collaborator OTHER
  • University of Copenhagen

    collaborator OTHER
  • University of Las Palmas Spain

    collaborator UNKNOWN
  • Duke University

    collaborator OTHER
  • Loughborough University

    lead OTHER

Principal Investigators

  • James Timmons, Professor · Loughborough University

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
55 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2012-04-30
Primary Completion
2014-04-30
Completion
2014-10-31

Countries

  • United Kingdom

Study Locations

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Entities

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01920659 on ClinicalTrials.gov