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The Effect of Aerobic Exercise on Genetic Molecules (xnx)

Primary Purpose

Diabetes Mellitus, Type 2, Aerobic Exercise, Genetic Response

Status
Completed
Phase
Not Applicable
Locations
Turkey
Study Type
Interventional
Intervention
exercise
Sponsored by
Pamukkale University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional supportive care trial for Diabetes Mellitus, Type 2 focused on measuring Type 2 diabetes mellitus, exercise, aerobic

Eligibility Criteria

30 Years - 74 Years (Adult, Older Adult)All SexesDoes not accept 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

Sites / Locations

  • Pamukkale University
  • Pamukkale University

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Active Comparator

Active Comparator

No Intervention

Arm Label

High intensity interval exercise

Moderate intensity continuous exercise

No Intervention: Control group

Arm 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.

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.

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.

Outcomes

Primary Outcome Measures

genetic molecules
HbA1c level in the serum

Secondary Outcome Measures

Full Information

First Posted
November 23, 2019
Last Updated
September 29, 2022
Sponsor
Pamukkale University
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1. Study Identification

Unique Protocol Identification Number
NCT04181853
Brief Title
The Effect of Aerobic Exercise on Genetic Molecules
Acronym
xnx
Official Title
The Effect of Aerobic Exercise on Genetic Molecules Related With Metabolism
Study Type
Interventional

2. Study Status

Record Verification Date
September 2022
Overall Recruitment Status
Completed
Study Start Date
February 5, 2020 (Actual)
Primary Completion Date
May 30, 2022 (Actual)
Study Completion Date
May 30, 2022 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Pamukkale University

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. 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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Diabetes Mellitus, Type 2, Aerobic Exercise, Genetic Response
Keywords
Type 2 diabetes mellitus, exercise, aerobic

7. Study Design

Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
The study has 3 arms
Masking
InvestigatorOutcomes Assessor
Masking Description
Participants wil be making exercise. It is not possible to make participants blinded to the study.
Allocation
Randomized
Enrollment
70 (Actual)

8. Arms, Groups, and Interventions

Arm Title
High intensity interval exercise
Arm Type
Active Comparator
Arm 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.
Arm Title
Moderate intensity continuous exercise
Arm Type
Active Comparator
Arm 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.
Arm Title
No Intervention: Control group
Arm Type
No Intervention
Arm 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.
Intervention Type
Other
Intervention Name(s)
exercise
Intervention Description
aerobic exercise
Primary Outcome Measure Information:
Title
genetic molecules
Description
HbA1c level in the serum
Time Frame
12 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
30 Years
Maximum Age & Unit of Time
74 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Gulin Findikoglu, Assoc Prof
Organizational Affiliation
Pamukkale University,Medical Faculty, PMR Department
Official's Role
Principal Investigator
Facility Information:
Facility Name
Pamukkale University
City
Denizli
ZIP/Postal Code
20100
Country
Turkey
Facility Name
Pamukkale University
City
Denizli
ZIP/Postal Code
21600
Country
Turkey

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

The Effect of Aerobic Exercise on Genetic Molecules

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