Prediabetic State Clinical Trial
Official title:
Impact of High Intensity Interval Training vs. Continuous Aerobic Training on Platelet Insulin Resistance, Platelet Function and Hepatic Steatosis in Patients With Prediabetes
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.
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.
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