NCT04181853

Brief Summary

The aim of this study is to compare the effects of high intensity interval exercise and moderate intensity continuous exercise on some genetic molecules 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
70

participants targeted

Target at P25-P50 for not_applicable diabetes-mellitus-type-2

Timeline
Completed

Started Feb 2020

Typical duration for not_applicable diabetes-mellitus-type-2

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

November 23, 2019

Completed
9 days until next milestone

First Posted

Study publicly available on registry

December 2, 2019

Completed
2 months until next milestone

Study Start

First participant enrolled

February 5, 2020

Completed
2.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 30, 2022

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

May 30, 2022

Completed
Last Updated

September 30, 2022

Status Verified

September 1, 2022

Enrollment Period

2.3 years

First QC Date

November 23, 2019

Last Update Submit

September 29, 2022

Conditions

Diabetes Mellitus, Type 2Aerobic ExerciseGenetic Response

Keywords

Type 2 diabetes mellitusexerciseaerobic

Outcome Measures

Primary Outcomes (1)

  • genetic molecules

    HbA1c level in the serum

    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

No Intervention: Control group

NO INTERVENTION

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.

Interventions

exerciseOTHER

aerobic exercise

High intensity interval exerciseModerate intensity continuous exercise

Eligibility Criteria

Age30 Years - 74 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Clinica diagnosis of type 2 Diabetes mellitus less than 10 years and more than 1 year.
  • must have appropriate medical therapy and diet.
  • must not be treated with insulin.
  • must be exercising less than 210 minutes/ week

You may not qualify if:

  • prominent cardiovascular disease
  • coronary artery disease
  • moderate to severe valvular disease
  • atrial fibrillation
  • untreated hypertension
  • congenital heart disease
  • retinopathy
  • neuropathy
  • macro albuminuria
  • cerebrovascular disease
  • ejection fraction less than 40
  • body mass index greater than 35.
  • prominent ischemic changes in EKG at rest or during exercise.
  • cigarette or alcohol addiction
  • 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

MeSH Terms

Conditions

Diabetes Mellitus, Type 2Motor Activity

Interventions

Exercise

Condition Hierarchy (Ancestors)

Diabetes MellitusGlucose Metabolism DisordersMetabolic DiseasesNutritional and Metabolic DiseasesEndocrine System DiseasesBehavior

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

Study Record Dates

First Submitted

November 23, 2019

First Posted

December 2, 2019

Study Start

February 5, 2020

Primary Completion

May 30, 2022

Study Completion

May 30, 2022

Last Updated

September 30, 2022

Record last verified: 2022-09

Data Sharing

IPD Sharing
Will not share

Locations

TU(2)