ClinicalTrials.gg
CompletedNCT03451201HIIT-T1DUpdated Mar 5, 2018

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

An interventional study of High Intensity Interval Training and Moderate Continuous Exercise Training in Type 1 Diabetes Mellitus and Endothelial Dysfunction, sponsored by Hospital de Clinicas de Porto Alegre. Completed at 1 site in Brazil. Open to participants aged 18 Years to 40 Years. Per ClinicalTrials.gov, last updated 2018-03-05.

Sponsored by Hospital de Clinicas de Porto Alegre · Not applicable, Interventional, and Supportive care

From the registry’s dates

  • Registered 3 years 1 month after the study started (first participant enrolled Jan 2015, registered Feb 2018).
Phase
Not applicable
Study type
Interventional
Enrollment
36
Allocation
Randomized
Ages
18 Years to 40 Years
Sex
All
01

Where this study stands

Counted across the records on this site · 2026-11-12

Among 48 studies in Diabetes Mellitus, Type 1 with a site in Brazil — 6 open to participants now, 10 under way, 5 of them phase 3. Diabetes Mellitus, Type 1 · Brazil.

Enrollment
30th of 43
36 · median 150
Started
2015
with 1 other
No phase
13 of 48
3 open now
Registered
32nd of 48
by date
Lead sponsor
3 of 48
Hospital de Clinicas de Porto Alegre

Among the 48 studies in Diabetes Mellitus, Type 1 with a site in Brazil, this one is the 30th largest by enrollment of the 43 interventional ones that give a count, is one of 2 that started in 2015, is one of 13 with no phase, and was the 32nd registered.

Diabetes Mellitus, Type 1

3,754 studies on the registry are indexed under Diabetes Mellitus, Type 1; 600 are open to participants now.

Browse Diabetes Mellitus, Type 1 studies →

Open to participants now

6 of the 48 studies in Diabetes Mellitus, Type 1 with a site in Brazil are open now. Recruiting first, the newest first:

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All 6 open studies →

A study can be open while its sites in Brazil have not opened yet or have stopped. Only those recruiting at a site in Brazil →

Who these studies take

Of the 411 Diabetes Mellitus, Type 1 studies recruiting now, 128 (31%) set no upper age limit and 257 (63%) stop at 75 or younger; 184 take children under 18; 64 take healthy volunteers.

This study: 18 Years to 40 Years · all sexes · no healthy volunteers.

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02

Study 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.

Read the 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.

03

Conditions studied

  • Type 1 Diabetes Mellitus
  • Endothelial Dysfunction

Keywords

  • Exercise
  • High-Intensity Interval Training
  • Type 1 diabetes
  • Endothelial Dysfunction
04

Who can participate

Ages eligible
18 Years to 40 Years
Sexes eligible
All
Accepts healthy volunteers
No

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

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

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.
05

Study design

Phase
Not applicable
Primary purpose
Supportive care
Allocation
Randomized
Intervention model
Parallel assignment
Masking
None (open label)
Enrollment
36 participants (actual)

Study arms

  • 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

  • Active comparator
    Moderate Continuous Exercise Training

    Moderate Continuous Interval Training

    Behavioral: Moderate Continuous Exercise Training

  • Other
    Non-exercise

    Sedentary Type 1 Diabetes Controls.

    Other: Non-exercise

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.

06

What researchers measure

Primary outcomes

  1. Endothelial Dependent Mediated Vascular Dilation

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

    Time frame: 8 weeks

Secondary outcomes

  1. Peak oxygen consumption

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

    Time frame: 8 weeks

  2. Endothelial independent vascular dilation

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

    Time frame: 8 weeks

07

Study locations

1 site
  • Serviço de Endocrinologia e Metabologia do HCPA
    Porto Alegre, RS 90035-0033, Brazil
08

References and documents

Publications

  • Mitranun W, Deerochanawong C, Tanaka H, Suksom D. Continuous vs interval training on glycemic control and macro- and microvascular reactivity in type 2 diabetic patients. Scand J Med Sci Sports. 2014 Apr;24(2):e69-76. doi: 10.1111/sms.12112. Epub 2013 Sep 17. PubMed 24102912 ↗
  • Corretti MC, Anderson TJ, Benjamin EJ, Celermajer D, Charbonneau F, Creager MA, Deanfield J, Drexler H, Gerhard-Herman M, Herrington D, Vallance P, Vita J, Vogel R; International Brachial Artery Reactivity Task Force. Guidelines for the ultrasound assessment of endothelial-dependent flow-mediated vasodilation of the brachial artery: a report of the International Brachial Artery Reactivity Task Force. J Am Coll Cardiol. 2002 Jan 16;39(2):257-65. doi: 10.1016/s0735-1097(01)01746-6. Erratum In: J Am Coll Cardiol 2002 Mar 20;39(6):1082. PubMed 11788217 ↗
  • Ce GV, Rohde LE, da Silva AM, Punales MK, de Castro AC, Bertoluci MC. Endothelial dysfunction is related to poor glycemic control in adolescents with type 1 diabetes under 5 years of disease: evidence of metabolic memory. J Clin Endocrinol Metab. 2011 May;96(5):1493-9. doi: 10.1210/jc.2010-2363. Epub 2011 Feb 23. Erratum In: J Clin Endocrinol Metab. 2011 Jun 1;96(6):1908. Coutinho, Marcia Khaled Punales [corrected to Punales, Marcia Khaled]. PubMed 21346068 ↗
  • Bertoluci MC, Ce GV, da Silva AM, Wainstein MV, Boff W, Punales M. Endothelial dysfunction as a predictor of cardiovascular disease in type 1 diabetes. World J Diabetes. 2015 Jun 10;6(5):679-92. doi: 10.4239/wjd.v6.i5.679. PubMed 26069717 ↗
  • Seeger JP, Thijssen DH, Noordam K, Cranen ME, Hopman MT, Nijhuis-van der Sanden MW. Exercise training improves physical fitness and vascular function in children with type 1 diabetes. Diabetes Obes Metab. 2011 Apr;13(4):382-4. doi: 10.1111/j.1463-1326.2011.01361.x. PubMed 21226819 ↗
  • Molmen-Hansen HE, Stolen T, Tjonna AE, Aamot IL, Ekeberg IS, Tyldum GA, Wisloff U, Ingul CB, Stoylen A. Aerobic interval training reduces blood pressure and improves myocardial function in hypertensive patients. Eur J Prev Cardiol. 2012 Apr;19(2):151-60. doi: 10.1177/1741826711400512. Epub 2011 Mar 4. PubMed 21450580 ↗
  • Eckstein ML, Farinha JB, McCarthy O, West DJ, Yardley JE, Bally L, Zueger T, Stettler C, Boff W, Reischak-Oliveira A, Riddell MC, Zaharieva DP, Pieber TR, Muller A, Birnbaumer P, Aziz F, Brugnara L, Haahr H, Zijlstra E, Heise T, Sourij H, Roden M, Hofmann P, Bracken RM, Pesta D, Moser O. Differences in Physiological Responses to Cardiopulmonary Exercise Testing in Adults With and Without Type 1 Diabetes: A Pooled Analysis. Diabetes Care. 2021 Jan;44(1):240-247. doi: 10.2337/dc20-1496. Epub 2020 Nov 12. PubMed 33184152 ↗
  • Boff W, da Silva AM, Farinha JB, Rodrigues-Krause J, Reischak-Oliveira A, Tschiedel B, Punales M, Bertoluci MC. Superior Effects of High-Intensity Interval vs. Moderate-Intensity Continuous Training on Endothelial Function and Cardiorespiratory Fitness in Patients With Type 1 Diabetes: A Randomized Controlled Trial. Front Physiol. 2019 Apr 24;10:450. doi: 10.3389/fphys.2019.00450. eCollection 2019. PubMed 31110479 ↗

Individual participant data

Plan to share: No

09

Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reachedSimilar studies: half by the dot; the band is the middle halfHalf of similar studies reached it by the dot; the band is the middle half, from a quarter to three quarters

Ran from Jan 2015 to primary completion in Jan 2016, 12 months.

Of 844 non-industry interventional studies with no phase under Diabetes Mellitus, Type 1, half reached primary completion within 19 months of starting (the median), counting those still running; a quarter within 10 and three quarters within 38. This study's 12 months is below that.

Counting every sponsor, half of 949 studies reached it within 18 months; a quarter within 9 and three quarters within 35.

How these figures are worked out, and which studies are left out of them.

Registered
Feb 23, 2018
First posted
Mar 1, 2018
StartActual
Jan 2015
Primary completionActual
Jan 2016
CompletionActual
Jan 2017
Last update
Mar 5, 2018
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Mar 5, 2018, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT03451201
Responsible party
Sponsor
First posted
Mar 1, 2018
Start date
Jan 2015
Primary completion
Jan 2016
Completion
Jan 2017
Last update
Mar 5, 2018

Study contacts

Marcello C Bertoluci, MD, PhD
principal investigator · Hospital de Clinicas de Porto Alegre

Oversight

Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Mar 2018. You cannot join it, but the record below documents what was studied.

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