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OpenTrials
Completed

NCT Number: NCT03451201

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

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.

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Key information

Conditions

Type 1 Diabetes Mellitus Autoimmune Diseases Behavior Diabetes Mellitus Diabetes Mellitus, Type 1 Endocrine System Diseases Endothelial Dysfunction Glucose Metabolism Disorders Immune System Diseases Metabolic Diseases Motor Activity Nutritional and Metabolic Diseases

Age range

18 year–40 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Serviço de Endocrinologia e Metabologia do HCPA

Porto Alegre, Rio Grande do Sul, 90035-0033, Brazil

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

T1DM

  • Physically inactive or not involved in exercise training programs in the previous 6 months
  • Interested in starting an exercise training program.

Exclusion criteria

  • Smokers,
  • Pregnancy
  • Co-morbidities not related to diabetes
  • Drugs other than insulin
  • Loss of renal function (serum creatinine above 1.5 mg/dl),
  • Moderate to severe retinopathy or blindness,
  • Suspected or confirmed coronary artery disease,
  • Severe peripheral neuropathy
  • Foot ulcers or history of previous foot ulcer
  • Suspected or confirmed clinical autonomic neuropathy.

Treatment and study plan

High Intensity Interval Training

Behavioral

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

Behavioral

Moderate Continuous Exercise Training 3 times a week for 8 weeks at 50% of maximal capacity

Non-exercise

Other

Conventional care for sedentary Type 1 Diabetes Controls. No intervention.

Primary outcomes

  1. Endothelial Dependent Mediated Vascular Dilation

    Time frame: 8 weeks

    Percent of change from baseline in flow mediated dilation measured through arterial ultrasound at right arm

Secondary outcomes

  1. Peak oxygen consumption

    Time frame: 8 weeks

    Percent of change in maximal oxygen capacity measured by in maximal oxygen consumption

  2. Endothelial independent vascular dilation

    Time frame: 8 weeks

    Percent of change from baseline in nitrate mediated dilation measured through arterial ultrasound at right arm

Sponsors and collaborators

Lead sponsor

Hospital de Clinicas de Porto Alegre

Other

Registry information

Official study title

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

Acronym: HIIT-T1D

Important dates

Study start
2015
Primary completion
2016
Study completion
2017
First posted
Mar 1, 2018
Registry last updated
Mar 5, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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