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

This study is ongoing, but not recruiting participants.
Sponsor:
Collaborator:
The Ministry of Science, Technology and Innovation, Denmark
Information provided by (Responsible Party):
Flemming Dela, University of Copenhagen
ClinicalTrials.gov Identifier:
NCT01732705
First received: October 12, 2012
Last updated: September 11, 2013
Last verified: September 2013
  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
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: 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 University of Copenhagen:

Primary Outcome Measures:
  • Insulin sensitivity [ Time Frame: 2 days after last training session (day 17) ] [ Designated as safety issue: No ]
    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. ] [ Designated as safety issue: No ]
    Analysis of glycogen content from muscle biopsies taken during the training period.


Estimated Enrollment: 20
Study Start Date: September 2012
Estimated Study Completion Date: December 2015
Estimated Primary Completion Date: December 2013 (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

Ages Eligible for Study:   40 Years to 65 Years
Genders 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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: 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

No publications provided

Responsible Party: Flemming Dela, Professor, MD., University of Copenhagen
ClinicalTrials.gov Identifier: NCT01732705     History of Changes
Other Study ID Numbers: HIT-T2DM
Study First Received: October 12, 2012
Last Updated: September 11, 2013
Health Authority: Denmark: National Board of Health
Denmark: Ethics Committee
Denmark: Danish Dataprotection Agency

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

Additional relevant MeSH terms:
Diabetes Mellitus
Diabetes Mellitus, Type 2
Endocrine System Diseases
Glucose Metabolism Disorders
Metabolic Diseases

ClinicalTrials.gov processed this record on October 20, 2014