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Metabolic, Physical Responses To Exercise In Patients With Type 2 Diabetes Mellitus

Primary Purpose

Type2 Diabetes Mellitus, Exercise

Status

Completed

Phase

Not Applicable

Locations

Turkey

Study Type

Interventional

Intervention

exercise

About this trial

This is an interventional supportive care trial for Type2 Diabetes Mellitus focused on measuring Type 2 diabetes mellitus, exercise, aerobic, interval, continuous

Eligibility Criteria

35 Years - 55 Years (Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

Participants must have type 2 Diabetes mellitus less than 10 years and more than 1 year.
Participants must have appropriate medical therapy and diet.
Participants must not be treated with insulin.
Participants must be exercising less than 210 minutes/ week.

Exclusion Criteria:

Participants with prominent cardiovascular disease
Participants with coronary artery disease
Participants with moderate to severe valvular disease
Participants with atrial fibrillation
Participants with untreated hypertension
Participants with congenital heart disease
Participants with retinopathy
Participants with neuropathy
Participants with macro albuminuria
Participants with cerebrovascular disease
Participants with ejection fraction less than 40
Participants with body mass index greater than 35.
Participants with prominent ischemic changes in EKG at rest or during exercise.
Participants with cigarette or alcohol addiction
Participants 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

No Intervention

Arm Label

High intensity interval exercise

Moderate intensity continuous exercise

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.

The participants in the control group will make stretching exercise at home

Outcomes

Primary Outcome Measures

Change in HbA1c level.

Change in HbA1c level measured in the blood after exercise compared to beginning

Secondary Outcome Measures

Full Information

NCT ID

NCT03682445

First Posted

September 21, 2018

Last Updated

December 14, 2020

Sponsor

Pamukkale University

1. Study Identification

Unique Protocol Identification Number

NCT03682445

Brief Title

Metabolic, Physical Responses To Exercise In Patients With Type 2 Diabetes Mellitus

Official Title

Metabolic, Physical Responses To Exercise In Patients With Type 2 Diabetes Mellitus

Study Type

Interventional

2. Study Status

Record Verification Date

December 2020

Overall Recruitment Status

Completed

Study Start Date

November 4, 2019 (Actual)

Primary Completion Date

December 1, 2020 (Actual)

Study Completion Date

December 14, 2020 (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

Studies a U.S. FDA-regulated Device Product

Data Monitoring Committee

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 metabolic parameters, physical measures, fitness level, body composition and miRNA-143 level 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 physical measures such as waist and hip circumference, fitness level measured by exercise testing, body composition measured by bioimpedance, metabolic parameters such as blood glucose level, HbA1C and measured by blood tests.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Type2 Diabetes Mellitus, Exercise

Keywords

Type 2 diabetes mellitus, exercise, aerobic, interval, continuous

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

60 (Actual)

8. Arms, Groups, and Interventions

Arm Title

High intensity interval exercise

Arm Type

Active Comparator

Arm Description

Arm Title

Moderate intensity continuous exercise

Arm Type

Active Comparator

Arm Description

Arm Title

Control group

Arm Type

No Intervention

Arm Description

The participants in the control group will make stretching exercise at home

Intervention Type

Other

Intervention Name(s)

exercise

Intervention Description

Aerobic tyep of exercise will be made at different intensities in 2 groups.

Primary Outcome Measure Information:

Title

Change in HbA1c level.

Description

Change in HbA1c level measured in the blood after exercise compared to beginning

Time Frame

12 weeks

10. Eligibility

Sex

All

Minimum Age & Unit of Time

35 Years

Maximum Age & Unit of Time

55 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: Participants must have type 2 Diabetes mellitus less than 10 years and more than 1 year. Participants must have appropriate medical therapy and diet. Participants must not be treated with insulin. Participants must be exercising less than 210 minutes/ week. Exclusion Criteria: Participants with prominent cardiovascular disease Participants with coronary artery disease Participants with moderate to severe valvular disease Participants with atrial fibrillation Participants with untreated hypertension Participants with congenital heart disease Participants with retinopathy Participants with neuropathy Participants with macro albuminuria Participants with cerebrovascular disease Participants with ejection fraction less than 40 Participants with body mass index greater than 35. Participants with prominent ischemic changes in EKG at rest or during exercise. Participants with cigarette or alcohol addiction Participants 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

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Metabolic, Physical Responses To Exercise In Patients With Type 2 Diabetes Mellitus

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