Back to resultsEffect of Training Intensity on Health Outcomes in Diabetes
Primary Purpose
Diabetes Mellitus, Type 2
Status
Completed
Phase
Not Applicable
Locations
Denmark
Study Type
Interventional
Intervention
Training
Sponsored by
About this trial
This is an interventional basic science trial for Diabetes Mellitus, Type 2 focused on measuring exercise
Eligibility Criteria
Inclusion Criteria:
Type 2 diabetes Age: 30-70 Non smokers (minimum the last 15 years) Inactive lifestyle (<2 hours pr. week) BMI <35 kg/m2
Exclusion Criteria:
Smoking Prior cardiavascular diseases Alcohol intake 14> units pr. week.
Sites / Locations
- August Krogh Building
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Experimental
Arm Label
Moderate intensity training
High intensity training
Arm Description
Moderate continuous exercise three times pr. week for 50 min.
High intensity interval training three times pr. week for 15 min.
Outcomes
Primary Outcome Measures
HbA1c
Long term blood glucose levels
Secondary Outcome Measures
Oral glucose tolerance test
75gr glucose is ingested, bllod sampling over the following two hours
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT03349944
Brief Title
Effect of Training Intensity on Health Outcomes in Diabetes
Official Title
Effect of High Intensity Interval Training on Nuclear Orphan Receptor Expression and Adrenergic Signaling in Skeletal Muscle of Persons With Type 2 Diabetes.
Study Type
Interventional
2. Study Status
Record Verification Date
April 2019
Overall Recruitment Status
Completed
Study Start Date
August 1, 2017 (Actual)
Primary Completion Date
December 21, 2018 (Actual)
Study Completion Date
January 8, 2019 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor-Investigator
Name of the Sponsor
Morten Hostrup, PhD
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
Brief Summary
The project will investigate high intensity interval training on the glucose regulation in type 2 diabetic subjects compared to moderate continuous exercise.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Diabetes Mellitus, Type 2
Keywords
exercise
7. Study Design
Primary Purpose
Basic Science
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
45 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Moderate intensity training
Arm Type
Active Comparator
Arm Description
Moderate continuous exercise three times pr. week for 50 min.
Arm Title
High intensity training
Arm Type
Experimental
Arm Description
High intensity interval training three times pr. week for 15 min.
Intervention Type
Behavioral
Intervention Name(s)
Training
Intervention Description
The duration of the training intervention is 10 weeks of either moderate exercise og high intensity interval training.
Primary Outcome Measure Information:
Title
HbA1c
Description
Long term blood glucose levels
Time Frame
From baseline measure to post test: 10 weeks
Secondary Outcome Measure Information:
Title
Oral glucose tolerance test
Description
75gr glucose is ingested, bllod sampling over the following two hours
Time Frame
From baseline measure to post test: 10 weeks
10. Eligibility
Sex
Male
Minimum Age & Unit of Time
30 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Type 2 diabetes Age: 30-70 Non smokers (minimum the last 15 years) Inactive lifestyle (<2 hours pr. week) BMI <35 kg/m2
Exclusion Criteria:
Smoking Prior cardiavascular diseases Alcohol intake 14> units pr. week.
Facility Information:
Facility Name
August Krogh Building
City
Copenhagen
Country
Denmark
12. IPD Sharing Statement
Plan to Share IPD
Undecided
Citations:
PubMed Identifier
33426802
Citation
Baasch-Skytte T, Gunnarsson TP, Fiorenza M, Bangsbo J. Skeletal muscle proteins important for work capacity are altered with type 2 diabetes - Effect of 10-20-30 training. Physiol Rep. 2021 Jan;9(1):e14681. doi: 10.14814/phy2.14681.
Results Reference
derived
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Effect of Training Intensity on Health Outcomes in Diabetes
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