The Effect of Aerobic Exercise on Genetic Molecules

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

Official Title
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The Effect of Aerobic Exercise on Genetic Molecules Related With Metabolism

Conditions
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Diabetes Mellitus, Type 2, Aerobic Exercise, Genetic Response

Intervention / Treatment
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* Other: exercise


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 30 Years
Maximum Age: 74 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Supportive Care
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: The study has 3 arms
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: High intensity interval exercise<br>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. | Other: exercise<br>* aerobic exercise<br>|
| Active Comparator: Moderate intensity continuous exercise<br>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. | Other: exercise<br>* aerobic exercise<br>|
| No Intervention: No Intervention: Control group<br>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?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| genetic molecules | HbA1c level in the serum | 12 weeks | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Type 2 diabetes mellitus, exercise, aerobic