- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03349944
Effect of Training Intensity on Health Outcomes in Diabetes
April 10, 2019 updated by: Morten Hostrup, PhD
Effect of High Intensity Interval Training on Nuclear Orphan Receptor Expression and Adrenergic Signaling in Skeletal Muscle of Persons With Type 2 Diabetes.
The project will investigate high intensity interval training on the glucose regulation in type 2 diabetic subjects compared to moderate continuous exercise.
Study Overview
Study Type
Interventional
Enrollment (Actual)
45
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
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Copenhagen, Denmark
- August Krogh Building
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-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
30 years to 70 years (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
Male
Description
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.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Basic Science
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Active Comparator: Moderate intensity training
Moderate continuous exercise three times pr.
week for 50 min.
|
The duration of the training intervention is 10 weeks of either moderate exercise og high intensity interval training.
|
|
Experimental: High intensity training
High intensity interval training three times pr.
week for 15 min.
|
The duration of the training intervention is 10 weeks of either moderate exercise og high intensity interval training.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
HbA1c
Time Frame: From baseline measure to post test: 10 weeks
|
Long term blood glucose levels
|
From baseline measure to post test: 10 weeks
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Oral glucose tolerance test
Time Frame: From baseline measure to post test: 10 weeks
|
75gr glucose is ingested, bllod sampling over the following two hours
|
From baseline measure to post test: 10 weeks
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
August 1, 2017
Primary Completion (Actual)
December 21, 2018
Study Completion (Actual)
January 8, 2019
Study Registration Dates
First Submitted
November 17, 2017
First Submitted That Met QC Criteria
November 17, 2017
First Posted (Actual)
November 22, 2017
Study Record Updates
Last Update Posted (Actual)
April 12, 2019
Last Update Submitted That Met QC Criteria
April 10, 2019
Last Verified
April 1, 2019
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- NOR
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
UNDECIDED
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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