NCT02039934

Brief Summary

High intensity interval training is applied for several diseases. Hypothesis: High intensity interval training improves insulin sensitivity 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
60

participants targeted

Target at P50-P75 for not_applicable type-2-diabetes

Timeline
Completed

Started Jul 2014

Longer than P75 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

First Submitted

Initial submission to the registry

September 7, 2012

Completed
1.4 years until next milestone

First Posted

Study publicly available on registry

January 20, 2014

Completed
5 months until next milestone

Study Start

First participant enrolled

July 1, 2014

Completed
4.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2018

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2018

Completed
Last Updated

August 14, 2023

Status Verified

August 1, 2023

Enrollment Period

4.1 years

First QC Date

September 7, 2012

Last Update Submit

August 7, 2023

Conditions

Type 2 Diabetes

Keywords

type 2 diabetesexercise interventionhigh intensity interval training

Outcome Measures

Primary Outcomes (1)

  • Improvement of Insulin sensitivity by high intensity interval training

    High intensity interval training leads to significant improvements in insulin action and oxidative phosphorylation in skeletal muscle.

    2 years

Study Arms (1)

high intensity interval training

EXPERIMENTAL

30 minute sessions of high-intensity interval training on a bicycle ergometer three times per week

Other: High intensity interval training

Interventions

High intensity interval trainingOTHER

The intervention consists of 30 minute sessions of high-intensity interval training on a bicycle ergometer three times per week. Training program: After 5 minutes of warm-up the subject cycles for 10 intervals of 60 s. at 90 % maximum effort separated 60 s at 20% maximum effort, based on a previously performed spiroergometry, followed by 5 minutes of cool-down.

high intensity interval training

Eligibility Criteria

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

You may qualify if:

  • Men and women
  • Age: 30 - 65 years
  • Typ-2-Diabetes (BMI \> 25 kg/m²)
  • Increased risk for diabetes (BMI \>25 kg/m²)

You may not qualify if:

  • Acute Infection within the last 2 weeks prior to the intervention
  • Autoimmune diseases and immune suppressive diseases (Leukocytes \< 5000/μl)
  • Intake of immunomodulating drugs (Glucocorticoids, Antihistamine, ASS)
  • Pregnancy, Breastfeeding, Menstruation
  • Kidney insufficiency (Creatinine \> 1,5 mg/dl)
  • Cardiovascular diseases
  • Anemia (Hb \< 12g/l), disorders of wound healing or blood clotting
  • Participation in another study within the last 2 months before the investigation
  • Metallic or magnetic items on or in the body
  • Claustrophobia
  • Thyroid dysfunction
  • Intake of glitazones or insulin therapy
  • Smoking (Non-smoking since \> 1 year), alcohol consumption (Men \> 30 g/d, Women \> 20g/d) or illegal drugs
  • Psychiatric disorders
  • Risk for/or manifest AIDS (HIV) or Hepatitis B or C
  • +8 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

German Diabetes Center

Düsseldorf, North Rhine-Westphalia, 40225, Germany

Location

Related Publications (1)

  • Apostolopoulou M, Mastrototaro L, Hartwig S, Pesta D, Strassburger K, de Filippo E, Jelenik T, Karusheva Y, Gancheva S, Markgraf D, Herder C, Nair KS, Reichert AS, Lehr S, Mussig K, Al-Hasani H, Szendroedi J, Roden M. Metabolic responsiveness to training depends on insulin sensitivity and protein content of exosomes in insulin-resistant males. Sci Adv. 2021 Oct 8;7(41):eabi9551. doi: 10.1126/sciadv.abi9551. Epub 2021 Oct 8.

    PMID: 34623918RESULT

Related Links

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

  • Michael Roden, Prof., MD

    German Diabetes Center

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
BASIC SCIENCE
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

September 7, 2012

First Posted

January 20, 2014

Study Start

July 1, 2014

Primary Completion

August 1, 2018

Study Completion

August 1, 2018

Last Updated

August 14, 2023

Record last verified: 2023-08

Locations

DE(1)