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

Type 1 Diabetes Mellitus Clinical Trial

— HIIT-T1D  

Official title:

Effect of High-Intensity Interval Exercise Training Compared With Moderate-intensity Continuous Training on Endothelial Function and Cardiorespiratory Fitness of Type 1 Diabetes Patients

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03451201
• Other study ID #: 150564
• Status: Completed
• Phase: N/A
• First received: February 23, 2018
• Last updated: March 1, 2018
• Start date: January 2015
• Est. completion date: January 2017

Study information

• Verified date: March 2018
• Source: Hospital de Clinicas de Porto Alegre
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 36
• Est. completion date: January 2017
• Est. primary completion date: January 2016
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 40 Years

Eligibility

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.

Related Conditions & MeSH terms

• Diabetes Mellitus
• Diabetes Mellitus, Type 1
• Endothelial Dysfunction
• Type 1 Diabetes Mellitus

Intervention

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

Other:
• Non-exercise
Conventional care for sedentary Type 1 Diabetes Controls. No intervention.

Locations

Country	Name	City	State
Brazil	Serviço de Endocrinologia e Metabologia do HCPA	Porto Alegre	RS

Sponsors (1)

Lead Sponsor	Collaborator
Hospital de Clinicas de Porto Alegre

Country where clinical trial is conducted

Brazil, 

References & Publications (6)

Bertoluci MC, Cé GV, da Silva AM, Wainstein MV, Boff W, Puñales 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. Review. — View Citation

Cé GV, Rohde LE, da Silva AM, Puñales 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, Márcia Khaled Puñales [corrected to Puñales, Márcia Khaled]. — View Citation

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. Erratum in: J Am Coll Cardiol 2002 Mar 20;39(6):1082. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Endothelial Dependent Mediated Vascular Dilation	Percent of change from baseline in flow mediated dilation measured through arterial ultrasound at right arm	8 weeks
Secondary	Peak oxygen consumption	Percent of change in maximal oxygen capacity measured by in maximal oxygen consumption	8 weeks
Secondary	Endothelial independent vascular dilation	Percent of change from baseline in nitrate mediated dilation measured through arterial ultrasound at right arm	8 weeks