High Intensity Interval Training (HIT) in Patients With Type 2 Diabetes (HIT_T2DM)
This study is currently recruiting participants.
Verified November 2012 by University of Copenhagen
Sponsor:
University of Copenhagen
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: November 23, 2012
Last verified: November 2012
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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:
|
|
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:
|
|
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
Please refer to this study by its ClinicalTrials.gov identifier: NCT01732705
Contacts
| Contact: Flemming Dela, MD. Prof. | +45 35327425 | fdela@sund.ku.dk |
Locations
| Denmark | |
| Xlab, Department of Biomedical Sciences, University of Copenhagen | Recruiting |
| Copenhagen N, Denmark, 2200 | |
| Contact: Flemming Dela, Professor fdela@sund.ku.dk | |
| Principal Investigator: Flemming Dela, Professor | |
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: | November 23, 2012 |
| 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 Insulin Resistance Glucose Metabolism Disorders |
Metabolic Diseases Endocrine System Diseases Hyperinsulinism |
ClinicalTrials.gov processed this record on May 16, 2013