The Effect of Aerobic Exercise on Genetic Molecules (xnx)

Pamukkale University

Status: Completed

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

Treatments: Other: exercise

Study type: Interventional

Funder types: Other

Identifiers

NCT04181853

60116787-020/83243

Details and patient eligibility

About

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.

Full 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.

Enrollment: 70 patients

Sex: All

Ages: 30 to 74 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Supportive Care

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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70 participants in 3 patient groups

High intensity interval exercise

Active Comparator group

Description:

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.

Treatment:

Other: exercise

Moderate intensity continuous exercise

Active Comparator group

Description:

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.

Treatment:

Other: exercise

No Intervention: Control group

No Intervention group

Description:

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.