Type2 Diabetes MellitusHRinT2DMNCT03917576
Heart Rate During Exercise in Type 2 Diabetes
A study testing Behavioral and Exercise training intervention in people with Type2 Diabetes Mellitus and Hyperglycemia, run by Universidad de Los Lagos at 1 site in Chile.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 60 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Type2 Diabetes Mellitus, Hyperglycemia, Heart Rate
- What is being tested?
- Behavioral and Exercise training intervention
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 75 participants
- Where
- 1 siteChile
- Study dates
- 4 Jan 2018to 7 Apr 2018
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 60 years
- Women only
- Healthy volunteers accepted
- Adult
Who may be able to join
- aged 18-60 y
- previously screened by physician professional
- diagnosed with normoglycaemic, prediabetes or T2D state
- living in Temuco city
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
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
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.
Read the 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).
- Conditions
- Type2 Diabetes Mellitus, Hyperglycemia, Heart Rate, Exercise Training
- Being tested
- Behavioral, Exercise training intervention
- Medical subject headings
- Hyperglycemia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
BehavioralOther
Also called Incremental exercise test
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.
Exercise training interventionOther
Also called Exercise training intervention with HIIT
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).
| Study group | Role | What they receive |
|---|---|---|
| Normoglicamic group | Active comparator | Control normoglycaemic participants Receives: Other: Exercise training intervention |
| Hyperglicaemic group | Active comparator | Control hyperglicaemic group Receives: Other: Exercise training intervention |
| Experimental group | Experimental | Experimental Type 2 Diabetes Mellitus Group Receives: Other: Behavioral |
What is being measured
The primary outcome is the main question the study is designed to answer.
Maximum heart rate
Measured before and after 12 weeks of high-intensity interval training
Measured: 12 weeks
Secondary outcomes (3)
Resting heart rate
Measured before and after 12 weeks of high-intensity interval training
Measured: 12 weeks
Heart rate pre each HIIT-interval
Measured before and after 12 weeks of high-intensity interval training
Measured: 12 weeks
Heart rate post each HIIT-interval
Measured before and after 12 weeks of high-intensity interval training
Measured: 12 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Apr 2019
- Study start4 Jan 2018
- Primary completion4 Apr 2018
- Study completion7 Apr 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Type2 Diabetes MellitusStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- 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
- Single blind
- Who is masked
- Investigator
- Enrolment
- 75 participants (actual)
Sponsor and investigators
- Lead sponsor
- Universidad de Los Lagos
- Sponsor type
- University, hospital or other
- Collaborators
- Universidad de La Frontera
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03917576
- Sponsor's protocol ID
- RP010317
- Acronym
- HRinT2DM
- Status last verified
- Apr 2019
- First submitted
- 7 Apr 2019
- Last updated
- 17 Apr 2019
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: We hope to send data of individual participant according with requirements by e-mail.
Study at a glance
From the registry record, last updated by the sponsor on 17 Apr 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT03917576
- Acronym / sponsor ID
- HRinT2DM / RP010317
- Conditions
- Type2 Diabetes Mellitus, Hyperglycemia, Heart Rate, Exercise Training
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 75 participants (actual)
- Lead sponsor
- Universidad de Los LagosUniversity, hospital or other
- Collaborators
- Universidad de La Frontera
- Study start
- 4 Jan 2018 (actual)
- Primary completion
- 4 Apr 2018 (actual)
- Study completion
- 7 Apr 2018 (actual)
- First posted
- 17 Apr 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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).
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (investigator)
- Number of arms
- 3
- Model description
- We will compare a type 2 diabetes mellitus group during exercise, with another hyperglicaemic, and normoglicaemic group in the heart rate maxymum.
| Arm | Type | Receives |
|---|---|---|
| Normoglicamic group | Active comparator | Other: Exercise training interventionControl normoglycaemic participants |
| Hyperglicaemic group | Active comparator | Other: Exercise training interventionControl hyperglicaemic group |
| Experimental group | Experimental | Other: BehavioralExperimental Type 2 Diabetes Mellitus Group |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- aged 18-60 y
- previously screened by physician professional
- diagnosed with normoglycaemic, prediabetes or T2D state
- living in Temuco city
Key exclusion criteria (3 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| BehavioralAlso: Incremental exercise testThe 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 | Experimental group |
| Exercise training interventionAlso: Exercise training intervention with HIITSubjects 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 | Hyperglicaemic group, Normoglicamic group |
Primary outcome
Maximum heart rate
Time frame: 12 weeks
Measured before and after 12 weeks of high-intensity interval training
3 secondary outcomes
Resting heart rate
Time frame: 12 weeks
Heart rate pre each HIIT-interval
Time frame: 12 weeks
Heart rate post each HIIT-interval
Time frame: 12 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Apr 2019.
- Individual participant dataSharing planned: No. We hope to send data of individual participant according with requirements by e-mail.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Behavioral and Exercise training intervention in people with Type2 Diabetes Mellitus and Hyperglycemia, run by Universidad de Los Lagos at 1 site in Chile.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 17 Apr 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Chile. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Maximum heart rate (time frame: 12 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 Apr 2019.