Clinical trial NCT03682445: 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
Overall status: COMPLETED
Phase: NA
Conditions: Type2 Diabetes Mellitus
Exercise
Keywords: Type 2 diabetes mellitus
exercise
aerobic
interval
continuous
Lead sponsor: Pamukkale University
Sponsor class: OTHER
First posted: 2018-09-24
Enrollment: 60
Sex: ALL
Minimum age (years): 35
Maximum age (years): 55
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: The study has 3 arms.
Primary purpose: SUPPORTIVE_CARE

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.

Eligibility criteria: 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)

Primary outcomes:
measure: Change in HbA1c level.
timeFrame: 12 weeks
Secondary outcomes:
Other outcomes:
Locations:
city: Denizli
country: Turkey
facility: Pamukkale University
city: Denizli
country: Turkey
facility: Pamukkale University
Study officials:
affiliation: pamukkale university, Medical Faculty, PMR Department
name: Gulin Findikoglu, Assoc Prof
role: PRINCIPAL_INVESTIGATOR
References: