Heart Rate During Exercise in Type 2 Diabetes (HRinT2DM)

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

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.

Study Overview

• Status: Completed
• Conditions: Hyperglycemia; Exercise Training; Type2 Diabetes Mellitus; Heart Rate
• Intervention / Treatment: Other: Exercise training intervention; Other: Behavioral

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).

• Study Type: Interventional
• Enrollment (Actual): 75
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Chile
  • Osorno, Chile, 5290000
    • Cristian ALvarez

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 60 years (Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: Female

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Normoglicamic group; Control normoglycaemic participants	Other: Exercise training intervention; 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).; Other Names: Exercise training intervention with HIIT
Active Comparator: Hyperglicaemic group; Control hyperglicaemic group	Other: Exercise training intervention; 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).; Other Names: Exercise training intervention with HIIT
Experimental: Experimental group; Experimental Type 2 Diabetes Mellitus Group	Other: Behavioral; 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.; Other Names: Incremental exercise test

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Maximum heart rate	Measured before and after 12 weeks of high-intensity interval training	12 weeks

Secondary Outcome Measures

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

Collaborators and Investigators

• Sponsor: Universidad de Los Lagos
• Collaborators: Universidad de La Frontera

Study record dates

Study Major Dates

• Study Start (Actual): January 4, 2018
• Primary Completion (Actual): April 4, 2018
• Study Completion (Actual): April 7, 2018

Study Registration Dates

• First Submitted: April 7, 2019
• First Submitted That Met QC Criteria: April 12, 2019
• First Posted (Actual): April 17, 2019

Study Record Updates

• Last Update Posted (Actual): April 17, 2019
• Last Update Submitted That Met QC Criteria: April 12, 2019
• Last Verified: April 1, 2019

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Glucose Metabolism Disorders; Metabolic Diseases; Endocrine System Diseases; Hyperglycemia; Diabetes Mellitus; Diabetes Mellitus, Type 2
• Other Study ID Numbers: RP010317

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO
• IPD Plan Description: We hope to send data of individual participant according with requirements by e-mail.

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No