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Heart Rate During Exercise in Type 2 Diabetes (HRinT2DM)

Primary Purpose

Type2 Diabetes Mellitus, Hyperglycemia, Heart Rate

Status
Completed
Phase
Not Applicable
Locations
Chile
Study Type
Interventional
Intervention
Behavioral
Exercise training intervention
Sponsored by
Universidad de Los Lagos
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Type2 Diabetes Mellitus

Eligibility Criteria

18 Years - 60 Years (Adult)FemaleAccepts Healthy Volunteers

Inclusion Criteria:

  • aged 18-60 y
  • previously screened by physician professional
  • diagnosed with normoglycaemic, prediabetes or T2D state
  • living in Temuco city

Exclusion Criteria:

  • low maximal cardiorespiratory fitness (defined as VO2max ≤21 ml/kg-1/min-1) below the expected value for the subject's sex and age
  • not receiving pharmacologic hypotensive treatment with β-blockers
  • having no musculoskeletal limitations to perform exercise cycling

Sites / Locations

  • Cristian ALvarez

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Active Comparator

Active Comparator

Experimental

Arm Label

Normoglicamic group

Hyperglicaemic group

Experimental group

Arm Description

Control normoglycaemic participants

Control hyperglicaemic group

Experimental Type 2 Diabetes Mellitus Group

Outcomes

Primary Outcome Measures

Maximum heart rate
Measured before and after 12 weeks of high-intensity interval training

Secondary Outcome Measures

Resting heart rate
Measured before and after 12 weeks of high-intensity interval training
Heart rate pre each HIIT-interval
Measured before and after 12 weeks of high-intensity interval training
Heart rate post each HIIT-interval
Measured before and after 12 weeks of high-intensity interval training

Full Information

First Posted
April 7, 2019
Last Updated
April 12, 2019
Sponsor
Universidad de Los Lagos
Collaborators
Universidad de La Frontera
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1. Study Identification

Unique Protocol Identification Number
NCT03917576
Brief Title
Heart Rate During Exercise in Type 2 Diabetes
Acronym
HRinT2DM
Official Title
Heart Rate Changes in Response to an Exercise Test and to a High Intensity Interval Training Session in Subjects With Normoglycaemic, Prediabetes, and Type 2 Diabetes Mellitus State
Study Type
Interventional

2. Study Status

Record Verification Date
April 2019
Overall Recruitment Status
Completed
Study Start Date
January 4, 2018 (Actual)
Primary Completion Date
April 4, 2018 (Actual)
Study Completion Date
April 7, 2018 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Universidad de Los Lagos
Collaborators
Universidad de La Frontera

4. Oversight

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

5. Study Description

Brief Summary
Exercise training is a cornerstone for the prevention and treatment of metabolic disorders and associated cardiometabolic complications such as type 2 diabetes mellitus (T2D) and hypertension. Similar to the beneficial health effects after performing conventional continuous exercise modalities, high intensity interval training (HIIT) has been reported as an effective alternative exercise-modality to improve glucose homeostasis in both prediabetes subjects and individuals with T2D diagnosed. In this regard, although multiple HIIT-based interventions commonly report acute and long term benefits on body composition, cardiorespiratory fitness and insulin sensitivity in metabolically compromised subjects, little is known about the acute cardiovascular response (i.e., at heart rate level) during HIIT in subjects with different glucose control. HIIT is described as performing brief periods of exercise at vigorous or maximal intensity, interspersed with inactive or low intensity recovery phases of variable duration. In order to characterize different HIIT-based protocols, exercise intensity is usually defined as relative percentages of individual maximal cardiorespiratory fitness (VO2max) or relative maximal power output values. Nevertheless, the need for specific technological equipment to assess these parameters usually limit the prescription and recommendations of HIIT in clinical settings and other public health contexts at massive level. Additionally, the use of self-perceived exertion scales and heart rate (HR) variations upon HIIT have been demonstrating to be accessible and feasible strategies to regulate exercise intensity during HIIT. For example, it was reported that HR and self-perceived exertion scores increased progressively in T2D subjects, parallel to the oxygen consumption rate throughout an acute HIIT session performed on cycle ergometer. Consequently, it is conceivable to hypothesize that determining HR variations during HIIT might optimize the recommendation of this training methodology in metabolically compromised subjects as those at risk or with T2D diagnosed. Therefore, the aim of the present study was To describe and compare the acute heart rate changes in response to an incremental maximal exercise test and a single HIIT session between normoglycaemic (NG), prediabetes (Pre-T2D) and type 2 diabetes mellitus (T2D) subjects.
Detailed Description
This cross-sectional study will use a non-probabilistic sample of 75 adult subjects, characterized as healthy normoglycaemic and others with disturbed glucose homeostasis subjects, all referred by a physician to the exercise programme of our research centre. The present study will be carried out in accordance with the Declaration of Helsinki and was approved by the Scientific Ethics Committee of the Universidad de La Frontera. All volunteers read and signed an informed consent. The inclusion criteria will be; a) aged 18-60 y; b) previously screened by physician professional; c) diagnosed with normoglycaemic, prediabetes or T2D state; d) and living in Temuco city. The exclusion criteria will be; a) low maximal cardiorespiratory fitness (defined as VO2max ≤21 ml/kg-1/min-1) below the expected value for the subject's sex and age 11; b) not receiving pharmacologic hypotensive treatment with β-blockers; and c) having no musculoskeletal limitations to perform exercise cycling. The total sample size will be divided in three groups according to the standard glycaemic classification 12; normoglycaemic (NG, n = 32), pre-diabetes (Pre-T2D, n = 30) and type 2 diabetes (T2D, n = 13). The study considered three stages of measurements (enrollment, exercise test, single HIIT session).

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Type2 Diabetes Mellitus, Hyperglycemia, Heart Rate, Exercise Training

7. Study Design

Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
We will compare a type 2 diabetes mellitus group during exercise, with another hyperglicaemic, and normoglicaemic group in the heart rate maxymum.
Masking
Investigator
Masking Description
The exercise session consisted of 1-minute cycling at high intensity (workload during each interval was set at ~80-100 % maximal power (i.e., load in Watts) achieved during the incremental exercise test with a workload that allowed to work until the volitional muscle failure in 1-minute), followed by 2-minutes of inactive resting period (sitting still on the cycle ergometer), and was repeated 10 times (1x2x10 protocol; 1:2:10 to work:rest:repetitions respectively). The exercise session was supervised individually by exercise professionals, monitoring the heart rate with a continuous telemetric heart rate sensor (Polar FT4, PolarTM, Finland). During the single HIIT session, the HR pre each interval (HR-preINT) and the HR post each interval (HR-postINT) of cycling was recorded individually. In addition, we calculated and report the percentage of maximum heart rate in each interval, delta of HR increment and delta HR recovery for each 10-interval HIIT are reported.
Allocation
Randomized
Enrollment
75 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Normoglicamic group
Arm Type
Active Comparator
Arm Description
Control normoglycaemic participants
Arm Title
Hyperglicaemic group
Arm Type
Active Comparator
Arm Description
Control hyperglicaemic group
Arm Title
Experimental group
Arm Type
Experimental
Arm Description
Experimental Type 2 Diabetes Mellitus Group
Intervention Type
Other
Intervention Name(s)
Behavioral
Other Intervention Name(s)
Incremental exercise test
Intervention Description
The resting heart rate (HRrest), maximum HR (HRmax), HR recovery (HRRTEST), delta HR recovery (ΔHRRTEST) were measured by continuous telemetric heart rate sensor (Polar FT4, PolarTM, Finland) during an incremental exercise test designed to obtain maximum oxygen consumption (VO2max) on a cycle ergometer (Lode Corival, Groningen, The Netherlands) similar with previous studies using similar cohort. An indirect calorimetry/ergospirometry system (Ultima CPXTM metabolic system, Medgraphics, Minnesota, USA) was used to measure VO2max until volitional exhaustion. Thus, the modified Astrand volitional protocol was applied in the participants of all NG, Pre-T2D and T2D groups increasing the load (i.e., Watts) 25 W each 2 min to women, and 50 W each 2 min to men.
Intervention Type
Other
Intervention Name(s)
Exercise training intervention
Other Intervention Name(s)
Exercise training intervention with HIIT
Intervention Description
Subjects also participated in a single HIIT session composed of 10-cycling intervals, using a Lode Corival cycle ergometer. The exercise session consisted of 1-minute cycling at high intensity (workload during each interval was set at ~80-100 % maximal power achieved during the incremental exercise test with a workload that allowed to work until the volitional muscle failure in 1-minute), followed by 2-minutes of inactive resting period (sitting still on the cycle ergometer), and was repeated 10 times (1x2x10 protocol; 1:2:10 to work:rest:repetitions respectively).
Primary Outcome Measure Information:
Title
Maximum heart rate
Description
Measured before and after 12 weeks of high-intensity interval training
Time Frame
12 weeks
Secondary Outcome Measure Information:
Title
Resting heart rate
Description
Measured before and after 12 weeks of high-intensity interval training
Time Frame
12 weeks
Title
Heart rate pre each HIIT-interval
Description
Measured before and after 12 weeks of high-intensity interval training
Time Frame
12 weeks
Title
Heart rate post each HIIT-interval
Description
Measured before and after 12 weeks of high-intensity interval training
Time Frame
12 weeks

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
60 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: aged 18-60 y previously screened by physician professional diagnosed with normoglycaemic, prediabetes or T2D state living in Temuco city Exclusion Criteria: low maximal cardiorespiratory fitness (defined as VO2max ≤21 ml/kg-1/min-1) below the expected value for the subject's sex and age not receiving pharmacologic hypotensive treatment with β-blockers having no musculoskeletal limitations to perform exercise cycling
Facility Information:
Facility Name
Cristian ALvarez
City
Osorno
ZIP/Postal Code
5290000
Country
Chile

12. IPD Sharing Statement

Plan to Share IPD
No
IPD Sharing Plan Description
We hope to send data of individual participant according with requirements by e-mail.

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Heart Rate During Exercise in Type 2 Diabetes

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