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

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

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT03682445
Enrollment
60
Registered
2018-09-24
Start date
2019-11-04
Completion date
2020-12-14
Last updated
2020-12-16

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Exercise, Type2 Diabetes Mellitus

Keywords

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

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.

Interventions

OTHERexercise

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

Sponsors

Pamukkale University
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SUPPORTIVE_CARE
Masking
DOUBLE (Investigator, Outcomes Assessor)

Masking description

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

Intervention model description

The study has 3 arms.

Eligibility

Sex/Gender
ALL
Age
35 Years to 55 Years
Healthy volunteers
No

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)

Design outcomes

Primary

MeasureTime frameDescription
Change in HbA1c level.12 weeksChange in HbA1c level measured in the blood after exercise compared to beginning

Countries

Turkey (Türkiye)

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 10, 2026