NCT02998008

Brief Summary

It is known from research that long-term exercise exposure in type 2 diabetes had positive effects. However, the effect of acute exercise in a patient group with already reduced cardiac function is not known. In this study, the impact of acute exhaustive high intensity interval training on cardiac function will be investigated in type 2 diabetes patients. One single session of exhaustive high intensity interval exercise training is expected to lead to a greater cardiac stress in diabetics than in non-diabetics, and in addition the right ventricle of the heart is expected to be more affected than the left ventricle.

Trial Health

57
Monitor

Trial Health Score

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

Enrollment
14

participants targeted

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

Timeline
Completed

Started Jan 2017

Geographic Reach
1 country

1 active site

Status
terminated

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

December 16, 2016

Completed
4 days until next milestone

First Posted

Study publicly available on registry

December 20, 2016

Completed
13 days until next milestone

Study Start

First participant enrolled

January 2, 2017

Completed
1.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2018

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2018

Completed
Last Updated

November 16, 2018

Status Verified

November 1, 2018

Enrollment Period

1.2 years

First QC Date

December 16, 2016

Last Update Submit

November 14, 2018

Conditions

Keywords

Exercise TherapyHeart Function TestsHeart/physiologyEchocardiography

Outcome Measures

Primary Outcomes (1)

  • echocardiography

    peak longitudinal systolic tricuspid annular velocity in cm/s

    30 minutes each measurement per subject

Study Arms (2)

Diabetes type 2 patients

OTHER

diabetes type 2 patients whose cardiac function is tested after 4x4 high intensity interval training

Behavioral: high intensity interval training

Healthy volunteers

OTHER

healthy volunteers whose cardiac function is tested after 4x4 high intensity interval training

Behavioral: high intensity interval training

Interventions

Diabetes type 2 patientsHealthy volunteers

Eligibility Criteria

Age30 Years - 60 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • Type II diabetes

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Department of Circulation and Medical Imaging, NTNU

Trondheim, Norway

Location

Related Publications (1)

  • Ness HO, Ljones K, Gjelsvik RH, Tjonna AE, Malmo V, Nilsen HO, Hollekim-Strand SM, Dalen H, Hoydal MA. Acute effects of high intensity training on cardiac function: a pilot study comparing subjects with type 2 diabetes to healthy controls. Sci Rep. 2022 May 17;12(1):8239. doi: 10.1038/s41598-022-12375-2.

MeSH Terms

Conditions

Diabetes Mellitus, Type 2

Interventions

High-Intensity Interval Training

Condition Hierarchy (Ancestors)

Diabetes MellitusGlucose Metabolism DisordersMetabolic DiseasesNutritional and Metabolic DiseasesEndocrine System Diseases

Intervention Hierarchy (Ancestors)

Physical Conditioning, HumanExerciseMotor ActivityMovementMusculoskeletal Physiological PhenomenaMusculoskeletal and Neural Physiological Phenomena

Study Officials

  • Øystein Risa, phd

    Norwegian University of Science and Technology

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
SUPPORTIVE CARE
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

December 16, 2016

First Posted

December 20, 2016

Study Start

January 2, 2017

Primary Completion

March 1, 2018

Study Completion

March 1, 2018

Last Updated

November 16, 2018

Record last verified: 2018-11

Locations