NCT01920659

Brief 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
188

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Apr 2012

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

April 1, 2012

Completed
1.4 years until next milestone

First Submitted

Initial submission to the registry

August 8, 2013

Completed
4 days until next milestone

First Posted

Study publicly available on registry

August 12, 2013

Completed
8 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 1, 2014

Completed
6 months until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2014

Completed
Last Updated

December 3, 2014

Status Verified

December 1, 2014

Enrollment Period

2 years

First QC Date

August 8, 2013

Last Update Submit

December 2, 2014

Conditions

Insulin SensitivityPhysical Activity

Keywords

High Intensity TrainingInsulin sensitivityFitness

Outcome Measures

Primary Outcomes (1)

  • Insulin Sensitivity

    Genomic methods and OGTT

    2 years

Secondary Outcomes (1)

  • Physical Fitness

    2 years

Study Arms (3)

High Intensity Training (HIT)

EXPERIMENTAL

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

Behavioral: High Intensity Training (HIT)

REHIT

EXPERIMENTAL

6 weeks of HIT, 3 times a week (20sec)

Behavioral: REHIT

control

NO INTERVENTION

control

Interventions

High Intensity Training (HIT)BEHAVIORAL

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

High Intensity Training (HIT)
REHITBEHAVIORAL

6 weeks 3 x week (20sec intervals)

REHIT

Eligibility Criteria

Age18 Years - 55 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • Sedentary behavior
  • BMI over 27 (kg/m2) or fasting glucose consistent with WHO criteria for impaired glucose tolerance

You may not qualify if:

  • Physical active

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Loughborough University

Loughborough, Leicestershire, LE11 5TN, United Kingdom

Location

Related Links

MeSH Terms

Conditions

Insulin ResistanceMotor Activity

Interventions

High-Intensity Interval Training

Condition Hierarchy (Ancestors)

HyperinsulinismGlucose Metabolism DisordersMetabolic DiseasesNutritional and Metabolic DiseasesBehavior

Intervention Hierarchy (Ancestors)

Physical Conditioning, HumanExerciseMotor ActivityMovementMusculoskeletal Physiological PhenomenaMusculoskeletal and Neural Physiological Phenomena

Study Officials

  • James Timmons, Professor

    Loughborough University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor

Study Record Dates

First Submitted

August 8, 2013

First Posted

August 12, 2013

Study Start

April 1, 2012

Primary Completion

April 1, 2014

Study Completion

October 1, 2014

Last Updated

December 3, 2014

Record last verified: 2014-12

Locations

GB(1)