- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03451201
High-Intensity Exercise and Endothelial Function in Type 1 Diabetes(HIIT-T1D) (HIIT-T1D)
March 1, 2018 updated by: Hospital de Clinicas de Porto Alegre
Effect of High-Intensity Interval Exercise Training Compared With Moderate-intensity Continuous Training on Endothelial Function and Cardiorespiratory Fitness of Type 1 Diabetes Patients
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.
Study Overview
Status
Completed
Conditions
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
Enrollment (Actual)
36
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
RS
-
Porto Alegre, RS, Brazil, 90035-0033
- Serviço de Endocrinologia e Metabologia do HCPA
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years to 40 years (Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
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.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Supportive Care
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: High Intensity Interval Training
High Intensity Interval Exercise Training in cycle ergometer 3 times a week for 8 weeks
|
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
|
Moderate Continuous Exercise Training 3 times a week for 8 weeks at 50% of maximal capacity
|
Other: Non-exercise
Sedentary Type 1 Diabetes Controls.
|
Conventional care for sedentary Type 1 Diabetes Controls.
No intervention.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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
|
8 weeks
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Peak oxygen consumption
Time Frame: 8 weeks
|
Percent of change in maximal oxygen capacity measured by in maximal oxygen consumption
|
8 weeks
|
Endothelial independent vascular dilation
Time Frame: 8 weeks
|
Percent of change from baseline in nitrate mediated dilation measured through arterial ultrasound at right arm
|
8 weeks
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Investigators
- Principal Investigator: Marcello C Bertoluci, MD, PhD, Hospital de Clínicas de Porto Alegre
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
General Publications
- 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.
- 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.
- 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.
- 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].
- 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.
- 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.
- 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.
- 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.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
January 1, 2015
Primary Completion (Actual)
January 1, 2016
Study Completion (Actual)
January 1, 2017
Study Registration Dates
First Submitted
February 23, 2018
First Submitted That Met QC Criteria
February 23, 2018
First Posted (Actual)
March 1, 2018
Study Record Updates
Last Update Posted (Actual)
March 5, 2018
Last Update Submitted That Met QC Criteria
March 1, 2018
Last Verified
March 1, 2018
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 150564
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
NO
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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