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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT03682445
Other study ID # GFindikoglu
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date November 4, 2019
Est. completion date December 14, 2020

Study information

Verified date December 2020
Source Pamukkale University
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.


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.


Recruitment information / eligibility

Status Completed
Enrollment 60
Est. completion date December 14, 2020
Est. primary completion date December 1, 2020
Accepts healthy volunteers No
Gender All
Age group 35 Years to 55 Years
Eligibility 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)

Study Design


Intervention

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

Locations

Country Name City State
Turkey Pamukkale University Denizli
Turkey Pamukkale University Denizli

Sponsors (1)

Lead Sponsor Collaborator
Pamukkale University

Country where clinical trial is conducted

Turkey, 

Outcome

Type Measure Description Time frame Safety issue
Primary Change in HbA1c level. Change in HbA1c level measured in the blood after exercise compared to beginning 12 weeks
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