NCT02333734

Brief Summary

The overall objective of this study is to examine the blood flow in the thigh muscles and sugar metabolism before and after 8 weeks of high intensity interval training (HIIT) on a bicycle ergometer in patients with type 2 diabetes (T2D) and matched controls. The following parameters are included in the assessment:

  • Sugar Metabolism
  • Muscle and fat mass
  • The blood flow at rest around the thigh muscles
  • Oxygen uptake test on a bicycle ergometer and 5 km time trial

Trial Health

87
On Track

Trial Health Score

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

Enrollment
23

participants targeted

Target at below P25 for not_applicable type-2-diabetes

Timeline
Completed

Started Jul 2014

Shorter than P25 for not_applicable type-2-diabetes

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

July 1, 2014

Completed
7 days until next milestone

First Submitted

Initial submission to the registry

July 8, 2014

Completed
5 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2014

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2014

Completed
1 month until next milestone

First Posted

Study publicly available on registry

January 7, 2015

Completed
Last Updated

February 3, 2015

Status Verified

February 1, 2015

Enrollment Period

5 months

First QC Date

July 8, 2014

Last Update Submit

February 2, 2015

Conditions

Keywords

Type 2 diabetesInterval trainingInsulin resistancefat metabolism

Outcome Measures

Primary Outcomes (1)

  • Oral Glucose tolerance test (OGTT)

    Change from baseline and 8 weeks in glucose/insulin response from a 2.5 hours oral glucose tolerance test (iAUC) after 8 weeks training

    baseline and 8 weeks

Secondary Outcomes (1)

  • Physical fitness

    baseline and 8 weeks

Other Outcomes (2)

  • Muscle and fat mass

    baseline and 8 weeks

  • blood flow

    baseline and 8 weeks

Study Arms (2)

Type 2 diabetic subjects

EXPERIMENTAL

Type 2 diabetic subjects physical training (interval training 3 times at week) in a period of 8 weeks.

Other: Physical training

Healthy subjects

EXPERIMENTAL

Healthy subjects physical training (interval training 3 times at week) in a period of 8 weeks.

Other: Physical training

Interventions

Performed supervised high intensity interval training 3 times a week over 8 weeks on a bicycle ergometer (with watt meter). During the training period, the trainee individually established program, each time with 10 × 60 sec. workout (interspersed with 60 sec. break) corresponding to a force which during the test cycle induces \~ 90% of the maximum heart rate. The time spent per session is expected to last \~ 25 minutes.

Healthy subjectsType 2 diabetic subjects

Eligibility Criteria

Age40 Years - 65 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Type 2 diabetes or matched healthy controls. T2D subject only : HbA1c \> 7,3. All subjects have an age between 40-65 years and a body mass index between 25-40 kg/m2. Both genders is allowed

You may not qualify if:

  • Severe diseases /immobility

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Aarhus Universityhospital, Aarhus University

Aarhus C, 8000, Denmark

Location

Related Publications (1)

  • Madsen SM, Thorup AC, Overgaard K, Jeppesen PB. High Intensity Interval Training Improves Glycaemic Control and Pancreatic beta Cell Function of Type 2 Diabetes Patients. PLoS One. 2015 Aug 10;10(8):e0133286. doi: 10.1371/journal.pone.0133286. eCollection 2015.

MeSH Terms

Conditions

Diabetes Mellitus, Type 2Insulin Resistance

Interventions

Physical Conditioning, Human

Condition Hierarchy (Ancestors)

Diabetes MellitusGlucose Metabolism DisordersMetabolic DiseasesNutritional and Metabolic DiseasesEndocrine System DiseasesHyperinsulinism

Intervention Hierarchy (Ancestors)

ExerciseMotor ActivityMovementMusculoskeletal Physiological PhenomenaMusculoskeletal and Neural Physiological Phenomena

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
BASIC SCIENCE
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Research Associate Prof. PhD

Study Record Dates

First Submitted

July 8, 2014

First Posted

January 7, 2015

Study Start

July 1, 2014

Primary Completion

December 1, 2014

Study Completion

December 1, 2014

Last Updated

February 3, 2015

Record last verified: 2015-02

Locations