High Intensity Interval Training in Prediabetes
Impact of High Intensity Interval Training vs. Continuous Aerobic Training on Platelet Insulin Resistance, Platelet Function and Hepatic Steatosis in Patients With Prediabetes
1 other identifier
interventional
44
1 country
1
Brief Summary
This trial investigates if high intensity interval training is more effective than moderate intensity continuous training in suppressing platelet reactivity and hepatic fat content in prediabetic individuals.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for not_applicable
Started Jan 2019
Typical duration for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
December 10, 2018
CompletedFirst Posted
Study publicly available on registry
December 12, 2018
CompletedStudy Start
First participant enrolled
January 4, 2019
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 1, 2020
CompletedStudy Completion
Last participant's last visit for all outcomes
February 1, 2021
CompletedJanuary 9, 2019
January 1, 2019
1.9 years
December 10, 2018
January 7, 2019
Conditions
Outcome Measures
Primary Outcomes (2)
EC50 (half-maximal effective concentration) of TRAP-6 (thrombin-receptor activating peptide) in terms of surface CD62P (=platelet selectin, P-selectin) expression: group differences after 12 weeks of training
12 weeks
EC50 of insulin in terms of intraplatelet VASP (vasodilator-stimulated phosphoprotein)-phosphorylation: group differences after 12 weeks of training
12 weeks
Secondary Outcomes (6)
whole body insulin sensitivity
12 weeks
Maximal oxygen consumption
12 weeks
EC50 of other platelet agonists in terms of various platelet activation markers
12 weeks
EC50 of prostacyclin in terms of intraplatelet VASP-phosphorylation
12 weeks
Transient elastography (FibroScan®) controlled attenuation parameter (CAP)
12 weeks
- +1 more secondary outcomes
Study Arms (2)
High intensity interval training
EXPERIMENTAL3x/week the following 45 min training protocol on bicycle ergometer for 12 weeks: * 5 minutes warm-up phase with a power output of 40% of the maximal power output achieved in an incremental exercise test * 30 minutes: intensive cycling bouts of 60s interspersed with 60s of recovery intervals. Power output will be 90% (week 1-6) or 95% (week 7-12) of the maximal power output of the exercise test during the intensive cycling bouts. During recovery intervals, subjects will pedal with a power output of 30% (week 1-6) or 35% (week 7-12) of the maximal power output of the exercise test. * 10 minutes with 30% of maximal power output.
Moderate intensity continuous training
ACTIVE COMPARATOR3x/week the following 45 min training protocol on bicycle ergometer for 12 weeks: * 5 minutes warm-up phase with a power output of 40% of the maximal power output achieved in an incremental exercise test * 30 minutes: Continuous training with 60% (week 1-6) or 65% (week 7-12) of maximal power output * 10 minutes with 30% of maximal power output.
Interventions
Exercise training on bicycle ergometer with high intensity bouts of 1 min interspersed by low intensity recovery intervals
Exercise training on bicycle ergometer with moderate intensity (60 - 65 % of individual maximal power output)
Eligibility Criteria
You may qualify if:
- prediabetic (insulin-insensitive) patients
- either fasting plasma glucose 100- 125 mg/dl or HbA1c 5.7 - 6.4
- \< 3kg bodyweight change within the last 6 months
You may not qualify if:
- Any contraindications for exercise
- resulting from anamnesis ( e.g. history of angina pectoris, peripheral arterial disease), ECG at rest or during graded exercise test, echocardiogram, echocardiography or lung function test
- chronical joint pain that makes exercise training on bicycle ergometers impossible
- any conditions that make the successful participation in the study unlikely
- islet cell autoantibodies
- Medication: insulin, thiazolidindiones, statins, antidepressants
- Secondary diseases: History of end-stage liver or kidney disease; pronounced neuropathy or retinopathy
- drug or alcohol abuse
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Medical University of Viennalead
- University of Vienna, Institute for Sport Sciencecollaborator
- Sanatorium Hera Viennacollaborator
Study Sites (1)
MUVienna
Vienna, 1090, Austria
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Who Masked
- INVESTIGATOR, OUTCOMES ASSESSOR
- Purpose
- BASIC SCIENCE
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Dr.med.univ. Dr.rer.nat.
Study Record Dates
First Submitted
December 10, 2018
First Posted
December 12, 2018
Study Start
January 4, 2019
Primary Completion
December 1, 2020
Study Completion
February 1, 2021
Last Updated
January 9, 2019
Record last verified: 2019-01