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

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ClinicalTrials.gov Identifier: NCT03451201
Recruitment Status : Completed
First Posted : March 1, 2018
Last Update Posted : March 5, 2018
Sponsor:
Information provided by (Responsible Party):
Hospital de Clinicas de Porto Alegre

Brief 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.

Condition or disease Intervention/treatment Phase
Type 1 Diabetes Mellitus Endothelial Dysfunction Behavioral: High Intensity Interval Training Behavioral: Moderate Continuous Exercise Training Other: Non-exercise Not Applicable

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.

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 36 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: Randomised Clinical Trial, 3 parallel groups: HIIT ( High-Intensity Interval Training) MCT (moderate intensity continuous training) and Sedentary Control Group.
Masking: None (Open Label)
Primary Purpose: Supportive Care
Official 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
Actual Study Start Date : January 2015
Actual Primary Completion Date : January 2016
Actual Study Completion Date : January 2017

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: High Intensity Interval Training
High Intensity Interval Exercise Training in cycle ergometer 3 times a week for 8 weeks
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

Active Comparator: Moderate Continuous Exercise Training
Moderate Continuous Interval Training
Behavioral: Moderate Continuous Exercise Training
Moderate Continuous Exercise Training 3 times a week for 8 weeks at 50% of maximal capacity

Non-exercise
Sedentary Type 1 Diabetes Controls.
Other: Non-exercise
Conventional care for sedentary Type 1 Diabetes Controls. No intervention.




Primary Outcome Measures :
  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 Outcome Measures :
  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



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Ages Eligible for Study:   18 Years to 40 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03451201


Locations
Brazil
Serviço de Endocrinologia e Metabologia do HCPA
Porto Alegre, RS, Brazil, 90035-0033
Sponsors and Collaborators
Hospital de Clinicas de Porto Alegre
Investigators
Principal Investigator: Marcello C Bertoluci, MD, PhD Hospital de Clinicas de Porto Alegre

Publications:

Responsible Party: Hospital de Clinicas de Porto Alegre
ClinicalTrials.gov Identifier: NCT03451201     History of Changes
Other Study ID Numbers: 150564
First Posted: March 1, 2018    Key Record Dates
Last Update Posted: March 5, 2018
Last Verified: March 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Hospital de Clinicas de Porto Alegre:
Exercise
High-Intensity Interval Training
Type 1 diabetes
Endothelial Dysfunction

Additional relevant MeSH terms:
Diabetes Mellitus
Diabetes Mellitus, Type 1
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases
Autoimmune Diseases
Immune System Diseases