NCT03451201

High-Intensity Exercise and Endothelial Function in Type 1 Diabetes(HIIT-T1D)

Effect of High-Intensity Interval Exercise Training Compared With Moderate-intensity Continuous Training on Endothelial Function and Cardiorespiratory Fitness of Type 1 Diabetes Patients

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 36 (actual)
• Sponsor: Hospital de Clinicas de Porto Alegre · Academic / Other
• Sex: All
• Age: 18 Years – 40 Years
• Healthy volunteers: Not accepted

Summary

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.

Detailed description

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.

Conditions

• Type 1 Diabetes Mellitus
• Endothelial Dysfunction

Interventions

Type	Name	Description
BEHAVIORAL	High Intensity Interval Training	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
BEHAVIORAL	Moderate Continuous Exercise Training	Moderate Continuous Exercise Training 3 times a week for 8 weeks at 50% of maximal capacity
OTHER	Non-exercise	Conventional care for sedentary Type 1 Diabetes Controls. No intervention.

Timeline

• Start date: 2015-01-01
• Primary completion: 2016-01-01
• Completion: 2017-01-01
• First posted: 2018-03-01
• Last updated: 2018-03-05

Locations

1 site across 1 country: Brazil