NCT03349944

Brief Summary

The project will investigate high intensity interval training on the glucose regulation in type 2 diabetic subjects compared to moderate continuous exercise.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
45

participants targeted

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

Timeline
Completed

Started Aug 2017

Geographic Reach
1 country

1 active site

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

Study Start

First participant enrolled

August 1, 2017

Completed
4 months until next milestone

First Submitted

Initial submission to the registry

November 17, 2017

Completed
5 days until next milestone

First Posted

Study publicly available on registry

November 22, 2017

Completed
1.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 21, 2018

Completed
18 days until next milestone

Study Completion

Last participant's last visit for all outcomes

January 8, 2019

Completed
Last Updated

April 12, 2019

Status Verified

April 1, 2019

Enrollment Period

1.4 years

First QC Date

November 17, 2017

Last Update Submit

April 10, 2019

Conditions

Diabetes Mellitus, Type 2

Keywords

exercise

Outcome Measures

Primary Outcomes (1)

  • HbA1c

    Long term blood glucose levels

    From baseline measure to post test: 10 weeks

Secondary Outcomes (1)

  • Oral glucose tolerance test

    From baseline measure to post test: 10 weeks

Study Arms (2)

Moderate intensity training

ACTIVE COMPARATOR

Moderate continuous exercise three times pr. week for 50 min.

Behavioral: Training

High intensity training

EXPERIMENTAL

High intensity interval training three times pr. week for 15 min.

Behavioral: Training

Interventions

TrainingBEHAVIORAL

The duration of the training intervention is 10 weeks of either moderate exercise og high intensity interval training.

High intensity trainingModerate intensity training

Eligibility Criteria

Age30 Years - 70 Years
Sexmale
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Type 2 diabetes Age: 30-70 Non smokers (minimum the last 15 years) Inactive lifestyle (\<2 hours pr. week) BMI \<35 kg/m2

You may not qualify if:

  • Smoking Prior cardiavascular diseases Alcohol intake 14\> units pr. week.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

August Krogh Building

Copenhagen, Denmark

Location

Related Publications (1)

  • Baasch-Skytte T, Gunnarsson TP, Fiorenza M, Bangsbo J. Skeletal muscle proteins important for work capacity are altered with type 2 diabetes - Effect of 10-20-30 training. Physiol Rep. 2021 Jan;9(1):e14681. doi: 10.14814/phy2.14681.

    PMID: 33426802DERIVED

MeSH Terms

Conditions

Diabetes Mellitus, Type 2Motor Activity

Condition Hierarchy (Ancestors)

Diabetes MellitusGlucose Metabolism DisordersMetabolic DiseasesNutritional and Metabolic DiseasesEndocrine System DiseasesBehavior

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
BASIC SCIENCE
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
Assistant Professor

Study Record Dates

First Submitted

November 17, 2017

First Posted

November 22, 2017

Study Start

August 1, 2017

Primary Completion

December 21, 2018

Study Completion

January 8, 2019

Last Updated

April 12, 2019

Record last verified: 2019-04

Locations

DK(1)