Clinical Trials Directory

Trials / Unknown

UnknownNCT03773731

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

Status
Unknown
Phase
N/A
Study type
Interventional
Enrollment
44 (estimated)
Sponsor
Medical University of Vienna · Academic / Other
Sex
Male
Age
19 Years – 75 Years
Healthy volunteers
Not accepted

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.

Detailed description

Background: The prevalence of type 2 diabetes mellitus (T2DM) is rising dramatically. T2DM represents a major cause for cardiovascular disease -related mortality and morbidity and increasingly burdens healthcare systems. While the fundamental pathomechanism of T2DM is insulin resistance of muscle and adipose tissue, recent studies demonstrate that insulin resistance in T2DM also occurs in platelets. As insulin directly inhibits platelet function, this mechanism might contribute to platelet activation and platelet hyperreactivity, which were in fact detected in diabetic patients. Since (inadvertent) platelet activation is causally linked to the development of atherosclerosis and atherothrombosis, regulation of platelet function is of utmost importance. Exercise training, performed on a regular basis has been shown to reduce morbidity and mortality in sedentary and diseased populations. Furthermore, exercise training improves whole body insulin sensitivity - however, it is currently unclear, if exercise training also affects insulin sensitivity of platelets. Recently, a time-saving interval training protocol has been adapted for T2DM-patients. Since this adapted high intensity interval training (HIIT) needs a fractional time commitment of exercise training according to current guidelines, HIIT possibly represents a promising instrument to increase adherence to exercise and thereby reduce T2DM morbidity. Aims: The primary aim of this study is to investigate the effect of 12 weeks of HIIT vs. continuous training (CT) on platelet insulin sensitivity and platelet (hyper)reactivity in prediabetic patients. Secondary aims are to assess the effect of HIIT and CT on whole body insulin sensitivity and fitness in prediabetic patients as well as on various parameters of platelet function and on the hepatic fat content. Hypotheses: Our main hypothesis is that HIIT increases platelet insulin sensitivity and thereby decreases platelet activation/reactivity in patients with prediabetes. Methods: 44 prediabetic (see inclusion criteria) patients will be enrolled in this study. Patients will randomly be assigned to a HIIT group (committed to a supervised training program) or a CT group. After initial examinations (supervised graded exercise test, platelet function tests, oral glucose tolerance test, measurement of the hepatic fat content via FibroScan®), supervised training will be performed over a period of 12 weeks. Tests performed at the beginning of the study will be repeated after the training period.

Conditions

Interventions

TypeNameDescription
BEHAVIORALHigh intensity interval training (HIIT)Exercise training on bicycle ergometer with high intensity bouts of 1 min interspersed by low intensity recovery intervals
BEHAVIORALModerate intensity continuous training (MICT)Exercise training on bicycle ergometer with moderate intensity (60 - 65 % of individual maximal power output)

Timeline

Start date
2019-01-04
Primary completion
2020-12-01
Completion
2021-02-01
First posted
2018-12-12
Last updated
2019-01-09

Locations

1 site across 1 country: Austria

Source: ClinicalTrials.gov record NCT03773731. Inclusion in this directory is not an endorsement.