Clinical trial NCT03917576: Heart Rate During Exercise in Type 2 Diabetes
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
Overall status: COMPLETED
Phase: NA
Conditions: Type2 Diabetes Mellitus
Hyperglycemia
Heart Rate
Exercise Training
Lead sponsor: Universidad de Los Lagos
Sponsor class: OTHER
Collaborators: name: Universidad de La Frontera
First posted: 2019-04-17
Enrollment: 75
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: We will compare a type 2 diabetes mellitus group during exercise, with another hyperglicaemic, and normoglicaemic group in the heart rate maxymum.
Primary purpose: PREVENTION

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).

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

Primary outcomes:
measure: Maximum heart rate
timeFrame: 12 weeks
Secondary outcomes:
measure: Resting heart rate
timeFrame: 12 weeks
measure: Heart rate pre each HIIT-interval
timeFrame: 12 weeks
measure: Heart rate post each HIIT-interval
timeFrame: 12 weeks
Other outcomes:
Locations:
city: Osorno
country: Chile
facility: Cristian ALvarez
Study officials:
References: