NCT01732705

Brief Summary

The purpose of this study is to determine the effect of High Intensity Interval Training (HIT) on insulin sensitivity in skeletal muscle in patients with type 2 diabetes.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
20

participants targeted

Target at below P25 for not_applicable type-2-diabetes

Timeline
Completed

Started Sep 2012

Typical duration 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

September 1, 2012

Completed
1 month until next milestone

First Submitted

Initial submission to the registry

October 12, 2012

Completed
2 months until next milestone

First Posted

Study publicly available on registry

November 26, 2012

Completed
2 years 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
Last Updated

February 9, 2021

Status Verified

February 1, 2021

Enrollment Period

2.2 years

First QC Date

October 12, 2012

Last Update Submit

February 8, 2021

Conditions

Type 2 Diabetes

Keywords

Type 2 diabetesInsulin sensitivityHigh intensity interval training

Outcome Measures

Primary Outcomes (1)

  • Insulin sensitivity

    Insulin sensitivity in trained and non-trained muscle will be measured by euglycemic hyperinsulinemic clamp method and a-v catheterization of both legs.

    2 days after last training session (day 17)

Other Outcomes (1)

  • Glycogen content in skeletal muscle

    17 days. Before and after training session day 1, 7 and 15. Before and immediately after isoglycemic, hyperinsulinemic clamp day 17.

Study Arms (4)

HIT (trained leg) DM

EXPERIMENTAL

High intensity interval training for one leg (trained leg) (randomized) in patient with type 2 diabetes

Behavioral: High intensity interval training

Control leg, DM

NO INTERVENTION

Control leg (untrained leg)in patient with type 2 diabetes

HIT (trained leg), Control subject

EXPERIMENTAL

High intensity interval training for one leg (trained leg) (randomized) in control subject

Behavioral: High intensity interval training

Control leg, Control subject

NO INTERVENTION

Control leg (untrained leg)in control subject

Interventions

High intensity interval trainingBEHAVIORAL

HIT will be conducted as 2 weeks of one legged high intense interval training (8 sessions every 2nd day). Each training session will consist of 10 x 1 min intervals on ergometer bicycle interspersed with 1 min recovery.

Also known as: High intense interval training, HIT, HIIT
HIT (trained leg) DMHIT (trained leg), Control subject

Eligibility Criteria

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

You may qualify if:

  • subjects with Type 2 diabetes. 10 healthy control subjects.
  • BMI 28-35
  • diet or tablet treatment for diabetes

You may not qualify if:

  • regular physical activity
  • diseases other than type 2 diabetes
  • insulin treatment

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Xlab, Department of Biomedical Sciences, University of Copenhagen

Copenhagen, 2200, Denmark

Location

Related Publications (1)

  • Dela F, Ingersen A, Andersen NB, Nielsen MB, Petersen HHH, Hansen CN, Larsen S, Wojtaszewski J, Helge JW. Effects of one-legged high-intensity interval training on insulin-mediated skeletal muscle glucose homeostasis in patients with type 2 diabetes. Acta Physiol (Oxf). 2019 Jun;226(2):e13245. doi: 10.1111/apha.13245. Epub 2019 Feb 14.

    PMID: 30585698DERIVED

MeSH Terms

Conditions

Diabetes Mellitus, Type 2Insulin Resistance

Interventions

High-Intensity Interval Training

Condition Hierarchy (Ancestors)

Diabetes MellitusGlucose Metabolism DisordersMetabolic DiseasesNutritional and Metabolic DiseasesEndocrine System DiseasesHyperinsulinism

Intervention Hierarchy (Ancestors)

Physical Conditioning, HumanExerciseMotor ActivityMovementMusculoskeletal Physiological PhenomenaMusculoskeletal and Neural Physiological Phenomena

Study Officials

  • Flemming Dela, MD. Prof.

    Xlab, Department of Biomedical Sciences, University of Copenhagen

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor, MD.

Study Record Dates

First Submitted

October 12, 2012

First Posted

November 26, 2012

Study Start

September 1, 2012

Primary Completion

December 1, 2014

Study Completion

December 1, 2014

Last Updated

February 9, 2021

Record last verified: 2021-02

Locations

DK(1)