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HIT_T2DM: High Intensity Interval Training (HIT) in Patients With Type 2 Diabetes

Sponsor
University of Copenhagen (Other)
Overall Status
Completed
CT.gov ID
NCT01732705
Collaborator
The Ministry of Science, Technology and Innovation, Denmark (Other)
20
Enrollment
1
Location
4
Arms
27
Duration (Months)
0.7
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

The purpose of this study is to determine the effect of High Intensity Interval Training (HIT) on insulin sensitivity in skeletal muscle in patients with type 2 diabetes.

Condition or Disease Intervention/Treatment Phase
  • Behavioral: High intensity interval training
 N/A

Detailed Description

Physical exercise increases insulin sensitivity in skeletal muscle in healthy as well as in individuals with type 2 diabetes, but implies a considerable time commitment. High intensity interval training (HIT) is time-efficient exercise consisting of repeated bouts of short duration high intensive workloads. The aim of this study is to determine the effect of HIT in patients with type 2 diabetes, and to clarify the mechanisms of a possible positive effect of HIT.

Exercise is performed as 2 weeks one-legged training on an ergometer bicycle. Thus one leg serves as a control leg. Insulin sensitivity in trained and non-trained muscle will be measured after completion of the overall training program by euglycemic hyperinsulinemic clamp method and a-v catheterization of both legs. Muscle biopsies will be obtained during training period for measuring of muscle glycogen content, and muscle biopsies for further analysis obtained during the experimental day.

Study Design

Study Type:
Interventional
Actual Enrollment :
20 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
None (Open Label)
Primary Purpose:
Treatment
Official Title:
Effect of High Intensity Interval Training (HIT) on Insulin Sensitivity in Patients With Type 2 Diabetes
Study Start Date :
Sep 1, 2012
Actual Primary Completion Date :
Dec 1, 2014
Actual Study Completion Date :
Dec 1, 2014

Arms and Interventions

Arm Intervention/Treatment
Experimental: HIT (trained leg) DM

High intensity interval training for one leg (trained leg) (randomized) in patient with type 2 diabetes

Behavioral: High intensity interval training
HIT will be conducted as 2 weeks of one legged high intense interval training (8 sessions every 2nd day). Each training session will consist of 10 x 1 min intervals on ergometer bicycle interspersed with 1 min recovery.
Other Names:
  • High intense interval training
  • HIT
  • HIIT

    		•
    No Intervention: Control leg, DM

    Control leg (untrained leg)in patient with type 2 diabetes
    Experimental: HIT (trained leg), Control subject

    High intensity interval training for one leg (trained leg) (randomized) in control subject

    Behavioral: High intensity interval training
    HIT will be conducted as 2 weeks of one legged high intense interval training (8 sessions every 2nd day). Each training session will consist of 10 x 1 min intervals on ergometer bicycle interspersed with 1 min recovery.
    Other Names:
  • High intense interval training
  • HIT
  • HIIT

    		•
    No Intervention: Control leg, Control subject

    Control leg (untrained leg)in control subject

    Outcome Measures

    Primary Outcome Measures

    1. Insulin sensitivity [2 days after last training session (day 17)]

      Insulin sensitivity in trained and non-trained muscle will be measured by euglycemic hyperinsulinemic clamp method and a-v catheterization of both legs.

    Other Outcome Measures

    1. Glycogen content in skeletal muscle [17 days. Before and after training session day 1, 7 and 15. Before and immediately after isoglycemic, hyperinsulinemic clamp day 17.]

      Analysis of glycogen content from muscle biopsies taken during the training period.

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    40 Years to 65 Years
    Sexes Eligible for Study:
    Male
    Accepts Healthy Volunteers:
    Yes
    Inclusion Criteria:

    • 10 subjects with Type 2 diabetes. 10 healthy control subjects.

    • BMI 28-35

    • diet or tablet treatment for diabetes

    Exclusion Criteria:

    • regular physical activity

    • diseases other than type 2 diabetes

    • insulin treatment

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Xlab, Department of Biomedical Sciences, University of Copenhagen Copenhagen Denmark 2200

    Sponsors and Collaborators

    • University of Copenhagen
    • The Ministry of Science, Technology and Innovation, Denmark

    Investigators

    • Principal Investigator: Flemming Dela, MD. Prof., Xlab, Department of Biomedical Sciences, University of Copenhagen

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Flemming Dela, Professor, MD., University of Copenhagen
    ClinicalTrials.gov Identifier:
    NCT01732705
    Other Study ID Numbers:
    • HIT-T2DM
    First Posted:
    Nov 26, 2012
    Last Update Posted:
    Feb 9, 2021
    Last Verified:
    Feb 1, 2021
    Keywords provided by Flemming Dela, Professor, MD., University of Copenhagen
    Type 2 diabetes
    Insulin sensitivity
    High intensity interval training
    Additional relevant MeSH terms:
    Diabetes Mellitus
    Diabetes Mellitus, Type 2

    Study Results

    No Results Posted as of Feb 9, 2021