The Effect of Aerobic Exercise on Genetic Molecules

NCT ID: NCT04181853

Last Updated: 2022-09-30

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

70 participants

Study Classification

INTERVENTIONAL

Study Start Date

2020-02-05

Study Completion Date

2022-05-30

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.

Conditions

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Diabetes Mellitus, Type 2 Aerobic Exercise Genetic Response

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

The study has 3 arms
Primary Study Purpose

SUPPORTIVE_CARE

Blinding Strategy

DOUBLE

Investigators Outcome Assessors
Participants wil be making exercise. It is not possible to make participants blinded to the study.

Study Groups

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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.

Group Type ACTIVE_COMPARATOR

exercise

Intervention Type OTHER

aerobic exercise

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.

Group Type ACTIVE_COMPARATOR

exercise

Intervention Type OTHER

aerobic exercise

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.

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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exercise

aerobic exercise

Intervention Type OTHER

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
Minimum Eligible Age

30 Years

Maximum Eligible Age

74 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Pamukkale University

OTHER

Sponsor Role lead

Responsible Party

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GULIN FINDIKOGLU

Associate Professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Gulin Findikoglu, Assoc Prof

Role: PRINCIPAL_INVESTIGATOR

Pamukkale University,Medical Faculty, PMR Department

Locations

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Pamukkale University

Denizli, , Turkey (Türkiye)

Site Status

Pamukkale University

Denizli, , Turkey (Türkiye)

Site Status

Countries

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Turkey (Türkiye)

Other Identifiers

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60116787-020/83243

Identifier Type: -

Identifier Source: org_study_id

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