xnx: The Effect of Aerobic Exercise on Genetic Molecules

Sponsor

Pamukkale University (Other)

Overall Status

Recruiting

CT.gov ID

NCT04181853

Collaborator

(none)

Enrollment

Locations

Arms

22.8

Anticipated Duration (Months)

Patients Per Site

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Diabetes Mellitus, Type 2 Aerobic Exercise Genetic Response	Other: exercise	N/A

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 Design

Study Type:

Interventional

Anticipated Enrollment :

90 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Intervention Model Description:

The study has 3 armsThe study has 3 arms

Masking:

Double (Investigator, Outcomes Assessor)

Masking Description:

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

Primary Purpose:

Supportive Care

Official Title:

The Effect of Aerobic Exercise on Genetic Molecules Related With Metabolism

Actual Study Start Date :

Feb 5, 2020

Anticipated Primary Completion Date :

Dec 30, 2021

Anticipated Study Completion Date :

Dec 31, 2021

Arms and Interventions

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.	Other: exercise 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.	Other: exercise 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.

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.

Other: exercise

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.

Other: exercise

aerobic exercise

No Intervention: No Intervention: Control group

Outcome Measures

Primary Outcome Measures

genetic molecules [12 weeks]
HbA1c level in the serum

Eligibility Criteria

Criteria

Ages Eligible for Study:

30 Years to 74 Years

Sexes Eligible for Study:

All

Accepts 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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Pamukkale University	Denizli		Turkey	20100
2	Pamukkale University	Denizli		Turkey	21600

Sponsors and Collaborators

Pamukkale University

Investigators

Principal Investigator: Gulin Findikoglu, Assoc Prof, Pamukkale University,Medical Faculty, PMR Department

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

GULIN FINDIKOGLU, Associate Professor, Pamukkale University

ClinicalTrials.gov Identifier:

NCT04181853

Other Study ID Numbers:

60116787-020/83243

First Posted:

Dec 2, 2019

Last Update Posted:

Dec 16, 2020

Last Verified:

Dec 1, 2020

Individual Participant Data (IPD) Sharing Statement:

Plan to Share IPD:

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Keywords provided by GULIN FINDIKOGLU, Associate Professor, Pamukkale University

Type 2 diabetes mellitus

exercise

aerobic

Additional relevant MeSH terms:

Diabetes Mellitus

Diabetes Mellitus, Type 2

Study Results

No Results Posted as of Dec 16, 2020