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Completed

NCT Number: NCT03682445

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

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.

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Key information

Age range

35 year–55 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Pamukkale University, Denizli, Turkey (Türkiye)

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About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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)

Treatment and study plan

Exercise

Other

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

Primary outcomes

  1. Change in HbA1c level.

    Time frame: 12 weeks

    Change in HbA1c level measured in the blood after exercise compared to beginning

Sponsors and collaborators

Lead sponsor

Pamukkale University

Other

Registry information

Important dates

Study start
2019
Primary completion
2020
Study completion
2020
First posted
Sep 24, 2018
Registry last updated
Dec 16, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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