NCT03682445

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
60

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Nov 2019

Geographic Reach
1 country

2 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

September 21, 2018

Completed
3 days until next milestone

First Posted

Study publicly available on registry

September 24, 2018

Completed
1.1 years until next milestone

Study Start

First participant enrolled

November 4, 2019

Completed
1.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2020

Completed
13 days until next milestone

Study Completion

Last participant's last visit for all outcomes

December 14, 2020

Completed
Last Updated

December 16, 2020

Status Verified

December 1, 2020

Enrollment Period

1.1 years

First QC Date

September 21, 2018

Last Update Submit

December 14, 2020

Conditions

Type2 Diabetes MellitusExercise

Keywords

Type 2 diabetes mellitusexerciseaerobicintervalcontinuous

Outcome Measures

Primary Outcomes (1)

  • Change in HbA1c level.

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

    12 weeks

Study Arms (3)

High intensity interval exercise

ACTIVE COMPARATOR

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.

Other: exercise

Moderate intensity continuous exercise

ACTIVE COMPARATOR

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.

Other: exercise

Control group

NO INTERVENTION

The participants in the control group will make stretching exercise at home

Interventions

exerciseOTHER

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

High intensity interval exerciseModerate intensity continuous exercise

Eligibility Criteria

Age35 Years - 55 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • 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.

You may not qualify if:

  • 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)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Pamukkale University

Denizli, 20100, Turkey (Türkiye)

Location

Pamukkale University

Denizli, 21600, Turkey (Türkiye)

Location

Related Publications (1)

  • Findikoglu G, Altinkapak A, Yaylali GF. Is isoenergetic high-intensity interval exercise superior to moderate-intensity continuous exercise for cardiometabolic risk factors in individuals with type 2 diabetes mellitus? A single-blinded randomized controlled study. Eur J Sport Sci. 2023 Oct;23(10):2086-2097. doi: 10.1080/17461391.2023.2167238. Epub 2023 Feb 5.

    PMID: 36622777DERIVED

MeSH Terms

Conditions

Motor ActivityDiabetes Mellitus, Type 2

Interventions

Exercise

Condition Hierarchy (Ancestors)

BehaviorDiabetes MellitusGlucose Metabolism DisordersMetabolic DiseasesNutritional and Metabolic DiseasesEndocrine System Diseases

Intervention Hierarchy (Ancestors)

Motor ActivityMovementMusculoskeletal Physiological PhenomenaMusculoskeletal and Neural Physiological Phenomena

Study Officials

  • Gulin Findikoglu, Assoc Prof

    pamukkale university, Medical Faculty, PMR Department

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
INVESTIGATOR, OUTCOMES ASSESSOR
Masking Details
Participants wil be making exercise. It is not possible to make participants blinded to the study.
Purpose
SUPPORTIVE CARE
Intervention Model
PARALLEL
Model Details: The study has 3 arms.
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Associate Professor, MD, PhD

Study Record Dates

First Submitted

September 21, 2018

First Posted

September 24, 2018

Study Start

November 4, 2019

Primary Completion

December 1, 2020

Study Completion

December 14, 2020

Last Updated

December 16, 2020

Record last verified: 2020-12

Data Sharing

IPD Sharing
Will not share

Locations

TU(2)