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

NCT ID: NCT03682445

Last Updated: 2020-12-16

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

60 participants

Study Classification

INTERVENTIONAL

Study Start Date

2019-11-04

Study Completion Date

2020-12-14

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 metabolic parameters, physical measures, fitness level, body composition and miRNA-143 level 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 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.

Conditions

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Type2 Diabetes Mellitus Exercise

Keywords

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Type 2 diabetes mellitus exercise aerobic interval continuous

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

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

Control group

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

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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exercise

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

Intervention Type OTHER

Eligibility Criteria

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Inclusion Criteria

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

Exclusion Criteria

1. Participants with prominent cardiovascular disease
2. Participants with coronary artery disease
3. Participants with moderate to severe valvular disease
4. Participants with atrial fibrillation
5. Participants with untreated hypertension
6. Participants with congenital heart disease
7. Participants with retinopathy
8. Participants with neuropathy
9. Participants with macro albuminuria
10. Participants with cerebrovascular disease
11. Participants with ejection fraction less than 40
12. Participants with body mass index greater than 35.
13. Participants with prominent ischemic changes in EKG at rest or during exercise.
14. Participants with cigarette or alcohol addiction
15. Participants on drugs that interferes with body fat distribution (such as insulin, thiazolidinediones)
Minimum Eligible Age

35 Years

Maximum Eligible Age

55 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, MD, PhD

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)

References

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Findikoglu G, Altinkapak A, Yaylali GF. Is isoenergetic high-intensity interval exercise superior to moderate-intensity continuous exercise for cardiometabolic risk factors in individuals with type 2 diabetes mellitus? A single-blinded randomized controlled study. Eur J Sport Sci. 2023 Oct;23(10):2086-2097. doi: 10.1080/17461391.2023.2167238. Epub 2023 Feb 5.

Reference Type DERIVED
PMID: 36622777 (View on PubMed)

Other Identifiers

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GFindikoglu

Identifier Type: -

Identifier Source: org_study_id