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

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01732705
First Posted: November 26, 2012
Last Update Posted: December 31, 2014
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Collaborator:
The Ministry of Science, Technology and Innovation, Denmark
Information provided by (Responsible Party):
Flemming Dela, University of Copenhagen
  Purpose
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 Intervention
Type 2 Diabetes Behavioral: High intensity interval training

Study Type: Interventional
Study Design: 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

Resource links provided by NLM:


Further study details as provided by Flemming Dela, University of Copenhagen:

Primary Outcome Measures:
  • Insulin sensitivity [ Time Frame: 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:
  • Glycogen content in skeletal muscle [ Time Frame: 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.


Enrollment: 20
Study Start Date: September 2012
Study Completion Date: December 2014
Primary Completion Date: December 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

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.

  Eligibility

Information from the National Library of Medicine

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

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
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01732705


Locations
Denmark
Xlab, Department of Biomedical Sciences, University of Copenhagen
Copenhagen N, 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
  More Information

Responsible Party: Flemming Dela, Professor, MD., University of Copenhagen
ClinicalTrials.gov Identifier: NCT01732705     History of Changes
Other Study ID Numbers: HIT-T2DM
First Submitted: October 12, 2012
First Posted: November 26, 2012
Last Update Posted: December 31, 2014
Last Verified: December 2014

Keywords provided by Flemming Dela, University of Copenhagen:
Type 2 diabetes
Insulin sensitivity
High intensity interval training

Additional relevant MeSH terms:
Diabetes Mellitus
Diabetes Mellitus, Type 2
Insulin Resistance
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases
Hyperinsulinism
Insulin
Hypoglycemic Agents
Physiological Effects of Drugs