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

Primary Purpose

Type 1 Diabetes Mellitus, Endothelial Dysfunction

Status
Completed
Phase
Not Applicable
Locations
Brazil
Study Type
Interventional
Intervention
High Intensity Interval Training
Moderate Continuous Exercise Training
Non-exercise
Sponsored by
Hospital de Clinicas de Porto Alegre
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional supportive care trial for Type 1 Diabetes Mellitus focused on measuring Exercise, High-Intensity Interval Training, Type 1 diabetes, Endothelial Dysfunction

Eligibility Criteria

18 Years - 40 Years (Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • Serviço de Endocrinologia e Metabologia do HCPA

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Active Comparator

Other

Arm Label

High Intensity Interval Training

Moderate Continuous Exercise Training

Non-exercise

Arm Description

High Intensity Interval Exercise Training in cycle ergometer 3 times a week for 8 weeks

Moderate Continuous Interval Training

Sedentary Type 1 Diabetes Controls.

Outcomes

Primary Outcome Measures

Endothelial Dependent Mediated Vascular Dilation
Percent of change from baseline in flow mediated dilation measured through arterial ultrasound at right arm

Secondary Outcome Measures

Peak oxygen consumption
Percent of change in maximal oxygen capacity measured by in maximal oxygen consumption
Endothelial independent vascular dilation
Percent of change from baseline in nitrate mediated dilation measured through arterial ultrasound at right arm

Full Information

First Posted
February 23, 2018
Last Updated
March 1, 2018
Sponsor
Hospital de Clinicas de Porto Alegre
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1. Study Identification

Unique Protocol Identification Number
NCT03451201
Brief Title
High-Intensity Exercise and Endothelial Function in Type 1 Diabetes(HIIT-T1D)
Acronym
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
Study Type
Interventional

2. Study Status

Record Verification Date
March 2018
Overall Recruitment Status
Completed
Study Start Date
January 2015 (Actual)
Primary Completion Date
January 2016 (Actual)
Study Completion Date
January 2017 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Hospital de Clinicas de Porto Alegre

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Type 1 Diabetes Mellitus, Endothelial Dysfunction
Keywords
Exercise, High-Intensity Interval Training, Type 1 diabetes, Endothelial Dysfunction

7. Study Design

Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
Randomised Clinical Trial, 3 parallel groups: HIIT ( High-Intensity Interval Training) MCT (moderate intensity continuous training) and Sedentary Control Group.
Masking
None (Open Label)
Allocation
Randomized
Enrollment
36 (Actual)

8. Arms, Groups, and Interventions

Arm Title
High Intensity Interval Training
Arm Type
Experimental
Arm Description
High Intensity Interval Exercise Training in cycle ergometer 3 times a week for 8 weeks
Arm Title
Moderate Continuous Exercise Training
Arm Type
Active Comparator
Arm Description
Moderate Continuous Interval Training
Arm Title
Non-exercise
Arm Type
Other
Arm Description
Sedentary Type 1 Diabetes Controls.
Intervention Type
Behavioral
Intervention Name(s)
High Intensity Interval Training
Intervention Description
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
Intervention Type
Behavioral
Intervention Name(s)
Moderate Continuous Exercise Training
Intervention Description
Moderate Continuous Exercise Training 3 times a week for 8 weeks at 50% of maximal capacity
Intervention Type
Other
Intervention Name(s)
Non-exercise
Intervention Description
Conventional care for sedentary Type 1 Diabetes Controls. No intervention.
Primary Outcome Measure Information:
Title
Endothelial Dependent Mediated Vascular Dilation
Description
Percent of change from baseline in flow mediated dilation measured through arterial ultrasound at right arm
Time Frame
8 weeks
Secondary Outcome Measure Information:
Title
Peak oxygen consumption
Description
Percent of change in maximal oxygen capacity measured by in maximal oxygen consumption
Time Frame
8 weeks
Title
Endothelial independent vascular dilation
Description
Percent of change from baseline in nitrate mediated dilation measured through arterial ultrasound at right arm
Time Frame
8 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
40 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Marcello C Bertoluci, MD, PhD
Organizational Affiliation
Hospital de Clinicas de Porto Alegre
Official's Role
Principal Investigator
Facility Information:
Facility Name
Serviço de Endocrinologia e Metabologia do HCPA
City
Porto Alegre
State/Province
RS
ZIP/Postal Code
90035-0033
Country
Brazil

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
24102912
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.
Results Reference
background
PubMed Identifier
11788217
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. doi: 10.1016/s0735-1097(01)01746-6. Erratum In: J Am Coll Cardiol 2002 Mar 20;39(6):1082.
Results Reference
background
PubMed Identifier
21346068
Citation
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].
Results Reference
background
PubMed Identifier
26069717
Citation
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.
Results Reference
background
PubMed Identifier
21226819
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.
Results Reference
background
PubMed Identifier
21450580
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.
Results Reference
background
PubMed Identifier
33184152
Citation
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.
Results Reference
derived
PubMed Identifier
31110479
Citation
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.
Results Reference
derived

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

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