An interventional study of High Intensity Interval Training and Moderate Continuous Exercise Training in Type 1 Diabetes Mellitus and Endothelial Dysfunction, sponsored by Hospital de Clinicas de Porto Alegre. Completed at 1 site in Brazil. Open to participants aged 18 Years to 40 Years. Per ClinicalTrials.gov, last updated 2018-03-05.
Sponsored by Hospital de Clinicas de Porto Alegre · Not applicable, Interventional, and Supportive care
To study the effect of 8 week high-intensity interval training (HIIT) compared with moderate intensity (MCT) interval training and sedentary patients(CON) with type 1 diabetes. Adult T1DM patients without known complications are randomised in blocks into these 3 groups according to their baseline flow mediated dilation (FMD). After 8 week exercise training, the main outcome, FMD, is re-evaluated. Additional variables such as VO2 peak for cardiovascular fitness, oxidative stress and endothelial independent vasodilation to study vascular rigidity are also evaluated.
In a randomized controlled open trial, 36 adult type 1 diabetes mellitus (T1DM) patients without known complications were randomized into 3 groups: HIIT n=12; MCT n=12 and a sedentary control group (CON) n=12. Total sample size was calculated to a power of 80% alha 0.05 and a difference in mean FMD of 2%. Before randomisation, flow mediated dilation (FMD) and maximal exercise capacity (VO2 peak)is determined. Block Randomisation based on FMD rank values are done to equalize baseline FMD. Exercise sessions are performed in cycle ergometers during 40 minutes, 3 times a week, along 8 weeks. HIIT protocol, intensity vary from 50 to 85% of the maximum heart rate (HRmax), while in MCT, HR remained stable at 50% HRmax. Endothelial function was measured by flow mediated dilation (FMD) for endothelium-dependent vasodilation (EDVD) and smooth-muscle function was measured by nitroglycerine mediated dilation (endothelium independent vascular dilation) - (EIVD). Peak oxygen consumption (VO2peak) and oxidative stress markers were determined before and after the training period. ED was defined as an increase of less than 8% in vascular diameter after cuff release.
T1DM
Exclusion Criteria:
High Intensity Interval Exercise Training in cycle ergometer 3 times a week for 8 weeks
Behavioral: High Intensity Interval Training
Moderate Continuous Interval Training
Behavioral: Moderate Continuous Exercise Training
Sedentary Type 1 Diabetes Controls.
Other: Non-exercise
High Intensity Interval Exercise Training in cycle ergometer, exercising at 80% of maximal capacity during one minute alternated with exercise at 50% of maximal capacity during 4 minutes intervals, for a total of 30 minutes. Three times a week for 8 weeks
Moderate Continuous Exercise Training 3 times a week for 8 weeks at 50% of maximal capacity
Conventional care for sedentary Type 1 Diabetes Controls. No intervention.
Endothelial Dependent Mediated Vascular Dilation
Percent of change from baseline in flow mediated dilation measured through arterial ultrasound at right arm
Time frame: 8 weeks
Peak oxygen consumption
Percent of change in maximal oxygen capacity measured by in maximal oxygen consumption
Time frame: 8 weeks
Endothelial independent vascular dilation
Percent of change from baseline in nitrate mediated dilation measured through arterial ultrasound at right arm
Time frame: 8 weeks
Plan to share: No
This study is completed, as verified in Mar 2018. You cannot join it, but the record below documents what was studied.
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Hospital de Clinicas de Porto Alegre