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

P

Pamukkale University

Status

Completed

Conditions

Type2 Diabetes Mellitus
Exercise

Treatments

Other: exercise

Study type

Interventional

Funder types

Other

Identifiers

NCT03682445
GFindikoglu

Details and patient eligibility

About

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.

Full 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.

Enrollment

60 patients

Sex

All

Ages

35 to 55 years old

Volunteers

No 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)

Trial design

Primary purpose

Supportive Care

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

Double Blind

60 participants in 3 patient groups

High intensity interval exercise
Active Comparator group
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.
Treatment:
Other: exercise
Moderate intensity continuous exercise
Active Comparator group
Description:
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.
Treatment:
Other: exercise
Control group
No Intervention group
Description:
The participants in the control group will make stretching exercise at home

Trial contacts and locations

0

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Data sourced from clinicaltrials.gov

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