The Effect of Aerobic Exercise on Genetic Molecules

Not Applicable

Completed

• Conditions: Diabetes Mellitus, Type 2; Genetic Response; Aerobic Exercise
• Interventions: Other: exercise

• Registration Number: NCT04181853
• Lead Sponsor: Pamukkale University

Brief Summary

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

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 Timeline

• Study First Submitted: 2019-11-23
• Study First Submitted QC: 2019-11-26
• Study First Posted: 2019-12-02
• Study Start: 2020-02-05
• Primary Completion: 2022-05-30
• Study Completion: 2022-05-30
• Status Verified: 2022-09
• Last Update Submitted: 2022-09-29
• Last Update Posted: 2022-09-30

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 70

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
High intensity interval exercise	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.
Moderate intensity continuous exercise	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.

Primary Outcome Measures

Name	Time	Method
genetic molecules	12 weeks	HbA1c level in the serum

Trial Locations

Locations (1)

Pamukkale University; 🇹🇷 Denizli, Turkey