Type 1 Diabetes Mellitus, Endothelial Dysfunction
Conditions
Keywords
Exercise, High-Intensity Interval Training, Type 1 diabetes, Endothelial Dysfunction
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.
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.
Interventions
BEHAVIORALHigh 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
BEHAVIORALModerate Continuous Exercise Training
Moderate Continuous Exercise Training 3 times a week for 8 weeks at 50% of maximal capacity
OTHERNon-exercise
Conventional care for sedentary Type 1 Diabetes Controls. No intervention.
Sponsors
Hospital de Clinicas de Porto Alegre
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SUPPORTIVE_CARE
Masking
NONE
Intervention model description
Randomised Clinical Trial, 3 parallel groups: HIIT ( High-Intensity Interval Training) MCT (moderate intensity continuous training) and Sedentary Control Group.
Eligibility
Sex/Gender
ALL
Age
18 Years to 40 Years
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Endothelial Dependent Mediated Vascular Dilation | 8 weeks | Percent of change from baseline in flow mediated dilation measured through arterial ultrasound at right arm |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Peak oxygen consumption | 8 weeks | Percent of change in maximal oxygen capacity measured by in maximal oxygen consumption |
| Endothelial independent vascular dilation | 8 weeks | Percent of change from baseline in nitrate mediated dilation measured through arterial ultrasound at right arm |
Countries
Brazil
Outcome results
None listed