High Intensity Interval Training in Prediabetes

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03773731
• Other study ID #: Exercise_platelet_insulin
• Status: Recruiting
• Phase: N/A
• Start date: January 4, 2019
• Est. completion date: February 2021

Study information

• Verified date: January 2019
• Source: Medical University of Vienna
• Contact: Ivo Volf, PhD
• Phone: +43 40160
• Email: ivo.volf[@]meduniwien.ac.at
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 44
• Est. completion date: February 2021
• Est. primary completion date: December 2020
• Accepts healthy volunteers: No
• Gender: Male
• Age group: 19 Years to 75 Years

Eligibility

Inclusion Criteria:

• 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

Exclusion Criteria:

• 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

Related Conditions & MeSH terms

• Prediabetic State

Intervention

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

Locations

Country	Name	City	State
Austria	MUVienna	Vienna

Sponsors (3)

Lead Sponsor	Collaborator
Medical University of Vienna	Sanatorium Hera Vienna, University of Vienna, Institute for Sport Science

Country where clinical trial is conducted

Austria, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	EC50 of insulin in terms of intraplatelet VASP (vasodilator-stimulated phosphoprotein)-phosphorylation: group differences after 12 weeks of training		12 weeks
Secondary	whole body insulin sensitivity		12 weeks
Secondary	Maximal oxygen consumption	Unit: ml/min/kg bodymass	12 weeks
Secondary	EC50 of other platelet agonists in terms of various platelet activation markers		12 weeks
Secondary	EC50 of prostacyclin in terms of intraplatelet VASP-phosphorylation		12 weeks
Secondary	Transient elastography (FibroScan®) controlled attenuation parameter (CAP)	The controlled attenuation parameter (CAP) has demonstrated good accuracy in quantifying the levels of liver steatosis and fibrosis in patients with NAFLD	12 weeks
Secondary	Fatty Liver Index (FLI)		12 weeks