High-Intensity Exercise and Endothelial Function in Type 1 Diabetes(HIIT-T1D)
HIIT-T1D
Effect of High-Intensity Interval Exercise Training Compared With Moderate-intensity Continuous Training on Endothelial Function and Cardiorespiratory Fitness of Type 1 Diabetes Patients
1 other identifier
interventional
36
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for not_applicable
Started Jan 2015
Typical duration for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
January 1, 2015
CompletedPrimary Completion
Last participant's last visit for primary outcome
January 1, 2016
CompletedStudy Completion
Last participant's last visit for all outcomes
January 1, 2017
CompletedFirst Submitted
Initial submission to the registry
February 23, 2018
CompletedFirst Posted
Study publicly available on registry
March 1, 2018
CompletedMarch 5, 2018
March 1, 2018
1 year
February 23, 2018
March 1, 2018
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Endothelial Dependent Mediated Vascular Dilation
Percent of change from baseline in flow mediated dilation measured through arterial ultrasound at right arm
8 weeks
Secondary Outcomes (2)
Peak oxygen consumption
8 weeks
Endothelial independent vascular dilation
8 weeks
Study Arms (3)
High Intensity Interval Training
EXPERIMENTALHigh Intensity Interval Exercise Training in cycle ergometer 3 times a week for 8 weeks
Moderate Continuous Exercise Training
ACTIVE COMPARATORModerate Continuous Interval Training
Non-exercise
OTHERSedentary Type 1 Diabetes Controls.
Interventions
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 3 times a week for 8 weeks at 50% of maximal capacity
Conventional care for sedentary Type 1 Diabetes Controls. No intervention.
Eligibility Criteria
You may qualify if:
- T1DM
- Physically inactive or not involved in exercise training programs in the previous 6 months
- Interested in starting an exercise training program.
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Serviço de Endocrinologia e Metabologia do HCPA
Porto Alegre, Rio Grande do Sul, 90035-0033, Brazil
Related Publications (8)
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.
PMID: 24102912BACKGROUNDCorretti 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.
PMID: 11788217BACKGROUNDCe 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.
PMID: 21346068BACKGROUNDBertoluci 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.
PMID: 26069717BACKGROUNDSeeger 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.
PMID: 21226819BACKGROUNDMolmen-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.
PMID: 21450580BACKGROUNDEckstein 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.
PMID: 33184152DERIVEDBoff 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.
PMID: 31110479DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Marcello C Bertoluci, MD, PhD
Hospital de Clinicas de Porto Alegre
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- SUPPORTIVE CARE
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
February 23, 2018
First Posted
March 1, 2018
Study Start
January 1, 2015
Primary Completion
January 1, 2016
Study Completion
January 1, 2017
Last Updated
March 5, 2018
Record last verified: 2018-03
Data Sharing
- IPD Sharing
- Will not share