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

Primary Purpose

Type 2 Diabetes

Status
Completed
Phase
Not Applicable
Locations
Denmark
Study Type
Interventional
Intervention
High intensity interval training
Sponsored by
University of Copenhagen
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Type 2 Diabetes focused on measuring Type 2 diabetes, Insulin sensitivity, High intensity interval training

Eligibility Criteria

40 Years - 65 Years (Adult, Older Adult)MaleAccepts Healthy Volunteers

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

Sites / Locations

  • Xlab, Department of Biomedical Sciences, University of Copenhagen

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm Type

Experimental

No Intervention

Experimental

No Intervention

Arm Label

HIT (trained leg) DM

Control leg, DM

HIT (trained leg), Control subject

Control leg, Control subject

Arm Description

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

Control leg (untrained leg)in patient with type 2 diabetes

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

Control leg (untrained leg)in control subject

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

Full Information

First Posted
October 12, 2012
Last Updated
February 8, 2021
Sponsor
University of Copenhagen
Collaborators
The Ministry of Science, Technology and Innovation, Denmark
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1. Study Identification

Unique Protocol Identification Number
NCT01732705
Brief Title
High Intensity Interval Training (HIT) in Patients With Type 2 Diabetes
Acronym
HIT_T2DM
Official Title
Effect of High Intensity Interval Training (HIT) on Insulin Sensitivity in Patients With Type 2 Diabetes
Study Type
Interventional

2. Study Status

Record Verification Date
February 2021
Overall Recruitment Status
Completed
Study Start Date
September 2012 (undefined)
Primary Completion Date
December 2014 (Actual)
Study Completion Date
December 2014 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Copenhagen
Collaborators
The Ministry of Science, Technology and Innovation, Denmark

4. Oversight

Data Monitoring Committee
No

5. 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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Type 2 Diabetes
Keywords
Type 2 diabetes, Insulin sensitivity, High intensity interval training

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
20 (Actual)

8. Arms, Groups, and Interventions

Arm Title
HIT (trained leg) DM
Arm Type
Experimental
Arm Description
High intensity interval training for one leg (trained leg) (randomized) in patient with type 2 diabetes
Arm Title
Control leg, DM
Arm Type
No Intervention
Arm Description
Control leg (untrained leg)in patient with type 2 diabetes
Arm Title
HIT (trained leg), Control subject
Arm Type
Experimental
Arm Description
High intensity interval training for one leg (trained leg) (randomized) in control subject
Arm Title
Control leg, Control subject
Arm Type
No Intervention
Arm Description
Control leg (untrained leg)in control subject
Intervention Type
Behavioral
Intervention Name(s)
High intensity interval training
Other Intervention Name(s)
High intense interval training, HIT, HIIT
Intervention Description
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.
Primary Outcome Measure Information:
Title
Insulin sensitivity
Description
Insulin sensitivity in trained and non-trained muscle will be measured by euglycemic hyperinsulinemic clamp method and a-v catheterization of both legs.
Time Frame
2 days after last training session (day 17)
Other Pre-specified Outcome Measures:
Title
Glycogen content in skeletal muscle
Description
Analysis of glycogen content from muscle biopsies taken during the training period.
Time Frame
17 days. Before and after training session day 1, 7 and 15. Before and immediately after isoglycemic, hyperinsulinemic clamp day 17.

10. Eligibility

Sex
Male
Minimum Age & Unit of Time
40 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Flemming Dela, MD. Prof.
Organizational Affiliation
Xlab, Department of Biomedical Sciences, University of Copenhagen
Official's Role
Principal Investigator
Facility Information:
Facility Name
Xlab, Department of Biomedical Sciences, University of Copenhagen
City
Copenhagen
ZIP/Postal Code
2200
Country
Denmark

12. IPD Sharing Statement

Citations:
PubMed Identifier
30585698
Citation
Dela F, Ingersen A, Andersen NB, Nielsen MB, Petersen HHH, Hansen CN, Larsen S, Wojtaszewski J, Helge JW. Effects of one-legged high-intensity interval training on insulin-mediated skeletal muscle glucose homeostasis in patients with type 2 diabetes. Acta Physiol (Oxf). 2019 Jun;226(2):e13245. doi: 10.1111/apha.13245. Epub 2019 Feb 14.
Results Reference
derived

Learn more about this trial

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

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