- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04181853
The Effect of Aerobic Exercise on Genetic Molecules (xnx)
September 29, 2022 updated by: GULIN FINDIKOGLU, Pamukkale University
The Effect of Aerobic Exercise on Genetic Molecules Related With Metabolism
The aim of this study is to compare the effects of high intensity interval exercise and moderate intensity continuous exercise on some genetic molecules in patients with type 2 diabetes mellitus.
Study Overview
Status
Completed
Intervention / Treatment
Detailed Description
Volunteers with type 2 diabetes mellitus will be evaluated in terms of any contra-indication that will restrain them from making exercise.
90 male or female volunteers who are suitable in terms of inclusion/exclusion criteria will be invited for the study.
Volunteers will be randomly distributed to one of the 3 groups.
Each group will contain 30 participants.
1. group will make aerobic exercise which is in the form of high intensity interval exercise 2.group will make aerobic exercise which is in the form of moderate intensity continuous exercise 3. Control group.
Exercise groups will be cycling under observation in the hospital setting.
Control group will make simple stretching exercises at home.
Participants will be requested to complete a 3 months of exercise.
They will be evaluated before and at the end of the 3 months of exercise with blood tests to measure genetic molecules related with metabolism.
Study Type
Interventional
Enrollment (Actual)
70
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
-
-
-
Denizli, Turkey, 21600
- Pamukkale University
-
Denizli, Turkey, 20100
- Pamukkale University
-
-
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 74 years (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
Inclusion Criteria:
Clinica diagnosis of type 2 Diabetes mellitus less than 10 years and more than 1 year.
- must have appropriate medical therapy and diet.
- must not be treated with insulin.
- must be exercising less than 210 minutes/ week
Exclusion Criteria:
- prominent cardiovascular disease
- coronary artery disease
- moderate to severe valvular disease
- atrial fibrillation
- untreated hypertension
- congenital heart disease
- retinopathy
- neuropathy
- macro albuminuria
- cerebrovascular disease
- ejection fraction less than 40
- body mass index greater than 35.
- prominent ischemic changes in EKG at rest or during exercise.
- cigarette or alcohol addiction
- on drugs that interferes with body fat distribution (such as insulin, thiazolidinediones
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: Supportive Care
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Double
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Active Comparator: High intensity interval exercise
Participants with type 2 Diabetes mellitus in High intensity interval exercise (HIIE) group will make aerobic exercise using bicycle at high intensity followed by low intensity periods under observation in the hospital.
|
aerobic exercise
|
Active Comparator: Moderate intensity continuous exercise
Participants with type 2 Diabetes mellitus in Moderate intensity continuous exercise (MIC) group will make aerobic exercise using bicycle at moderate intensity during the session under observation in the hospital.
|
aerobic exercise
|
No Intervention: No Intervention: Control group
Participants with type 2 Diabetes mellitus in Moderate intensity continuous exercise (MIC) group will make aerobic exercise using bicycle at moderate intensity during the session under observation in the hospital.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
genetic molecules
Time Frame: 12 weeks
|
HbA1c level in the serum
|
12 weeks
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Principal Investigator: Gulin Findikoglu, Assoc Prof, Pamukkale University,Medical Faculty, PMR Department
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)
February 5, 2020
Primary Completion (Actual)
May 30, 2022
Study Completion (Actual)
May 30, 2022
Study Registration Dates
First Submitted
November 23, 2019
First Submitted That Met QC Criteria
November 26, 2019
First Posted (Actual)
December 2, 2019
Study Record Updates
Last Update Posted (Actual)
September 30, 2022
Last Update Submitted That Met QC Criteria
September 29, 2022
Last Verified
September 1, 2022
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- 60116787-020/83243
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
NO
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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