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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

36 participants

Study Classification

INTERVENTIONAL

Study Start Date

2015-01-31

Study Completion Date

2017-01-31

Brief Summary

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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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Detailed Description

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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

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Type 1 Diabetes Mellitus Endothelial Dysfunction

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Randomised Clinical Trial, 3 parallel groups: HIIT ( High-Intensity Interval Training) MCT (moderate intensity continuous training) and Sedentary Control Group.

Primary Study Purpose

SUPPORTIVE_CARE

Blinding Strategy

NONE

Study Groups

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High Intensity Interval Training

High Intensity Interval Exercise Training in cycle ergometer 3 times a week for 8 weeks

Group Type EXPERIMENTAL

High Intensity Interval Training

Intervention Type 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

Moderate Continuous Interval Training

Group Type ACTIVE_COMPARATOR

Moderate Continuous Exercise Training

Intervention Type BEHAVIORAL

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

Non-exercise

Sedentary Type 1 Diabetes Controls.

Group Type OTHER

Non-exercise

Intervention Type OTHER

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

Interventions

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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

Intervention Type BEHAVIORAL

Moderate Continuous Exercise Training

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

Intervention Type BEHAVIORAL

Non-exercise

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

Intervention Type OTHER

Eligibility Criteria

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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.

Minimum Eligible Age

18 Years

Maximum Eligible Age

40 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No