Diabetes Mellitus, Type 2NCT03191435
Inspiratory Muscle Training on Glycemic Control in Individuals With Type 2 Diabetes
A study testing Inspiratory muscle training. in people with Diabetes Mellitus, Type 2, run by Hospital de Clinicas de Porto Alegre at 1 site in Brazil.
Trial summary
In diabetic individuals, changes in ventilatory muscle strength and lung function have been demonstrated over the years. The onset and progression of chronic complications in diabetes should be avoided by reaching glycated hemoglobin (HbA1c) levels below 7%. Read more about this study
- Who is it for?
- Ages 30 years and older
- Conditions the study is for
- Diabetes Mellitus, Type 2
- What is being tested?
- Inspiratory muscle training.
- Type of treatment
- Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 30 participants
- Where
- 1 siteBrazil
- Study dates
- 11 Jul 2017to 31 Jan 2019
- 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 30 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Type 2 diabetes;
- 30 years and older;
- HbA1c from 7,5 to 10%.
Who cannot join
- Pregnant women;
- Pulmonary disease (chronic obstructive pulmonary disease, exercise-induced asthma, idiopathic pulmonary fibrosis, sarcoidosis and lung neoplasms);
- Neuromuscular disease;
- Body mass index > 35 kg/m²;
- Individuals who perform physical exercise more than twice a week;
- Current smoking.
Trial locations and contacts
1 site in 1 country.
Brazil1 site, 1 recruiting
- Recruiting
Hospital de Clínicas de Porto Alegre
Porto Alegre, Rio Grande do Sul, 90.035-903
Beatriz D'agord Schaan, PhD, bschaan@hcpa.edu.br
About this study
Official title: Effect of Inspiratory Muscle Training on Glycemic Control in Individuals With Type 2 Diabetes:Randomized Clinical Trial
In diabetic individuals, changes in ventilatory muscle strength and lung function have been demonstrated over the years. The onset and progression of chronic complications in diabetes should be avoided by reaching glycated hemoglobin (HbA1c) levels below 7%. The control of glycemia through the measurement of HbA1c is fundamental to avoid complications. The inspiratory muscle training has been used in several clinical situations, and may be an alternative for individuals with type 2 diabetes mellitus who have difficulties performing conventional exercises. The long-term effect of inspiratory muscle training on glycemic control has not been tested yet. The aim of this study is to evaluate the effects of inspiratory muscle training on glycemic control in individuals with type 2 diabetes.
Read the detailed description
An acute high intensity inspiratory muscle exercise session was able to reduce glycemic levels (24%) similarly to an aerobic exercise session (25%) in subjects with type 2 diabetes, demonstrating that this type of exercise inspiratory muscle may have great potential in improving glycemic control.The present study will investigate if training of the inspiratory musculature for 8 and 12 weeks is capable of improving glycated hemoglobin, glucose and inspiratory muscle strength in individuals with type 2 diabetes. In addition, this study will evaluate the effect of inspiratory muscle training, with moderate loading of 30% of the MIP, on volumes and capacities lung in patients with type 2 diabetes. The subjects with type 2 diabetes will be recruited from the ambulatory of the Hospital de Clinicas de Porto Alegre and through newspaper advertisements.
Patients will be submitted to a general evaluation, including clinical history, physical examination, laboratory evaluation and application of the international physical activity questionnaire. Subsequently, individuals will perform assessments of lung functions (lung function assessment, ventilatory muscle strength test, inspiratory muscle strength test) and autonomic assessment (Ewing's tests). Patients will be randomized to perform inspiratory muscle training with a placebo load (MIP 2%) or with moderate intensity (MIP 30%). Upon the randomization, participants will initiate inspiratory musculature training. The exams of HbA1c, glucose and ventilatory muscle strength tests will be performed in three moments: 1) at the initial assessment, 2) in the eighth week of inspiratory muscle training, and 3) at the end of the training (twelfth) week. During inspiratory muscle training, individuals will attend on Hospital de Clinicas de Porto Alegre, once a week, to the supervision of the way the exercise is being performed. Furthermore, it will be set to load on the PowerBreathe ® device for the following week.
- Conditions
- Diabetes Mellitus, Type 2
- Being tested
- Inspiratory muscle training., Placebo inspiratory muscle
- Keywords
- Diabetes mellitus, type 2, Inspiratory muscle training, Glycemic control, Glucose, Exercise, Diaphragm exercise, Inspiratory loading
- Medical subject headings
- Diabetes Mellitus, Type 2, Motor Activity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Inspiratory muscle training.Device
Patients will perform the inspiratory muscle training using a moderate load of 30% of maximal inspiratory pressure (MIP 30%). The training will be conducted at home in a period of 30 minutes, 7 times a week, during 12 weeks. During inspiratory muscle training, individuals will attend Hospital de Clinicas de Porto Alegre once a week to the supervision of the way the exercise is being performed. Furthermore, load in the device (powerbreathe) will be adjusted for the individual to use next week.
Placebo inspiratory muscleDevice
Patients will perform the inspiratory muscle training using a very low load of 2% of maximal inspiratory pressure (MIP 2%). The training will be conducted at home in a period of 30 minutes, 7 times a week, in the course of 12 weeks. During inspiratory muscle training, individuals will attend Hospital de Clinicas de Porto Alegre once a week to the supervision of the way the exercise is being performed.
| Study group | Role | What they receive |
|---|---|---|
| Inspiratory muscle training | Experimental | Patients will perform the inspiratory muscle training using a load moderate of 30% of maximal inspiratory pressure (MIP 30%). Receives: Device: Inspiratory muscle training. |
| Placebo inspiratory muscle | Placebo comparator | Patients will perform the inspiratory muscle training using a load of 2% of maximal inspiratory pressure (MIP 2%). Receives: Device: Placebo inspiratory muscle |
What is being measured
The primary outcome is the main question the study is designed to answer.
Glycated hemoglobin in 8 weeks
Glycated hemoglobin concentration after 8 weeks of inspiratory muscle training
Measured: Evaluated in 8 weeks of inspiratory muscle training
Glycated hemoglobin in 12 weeks
Glycated hemoglobin concentration after 12 weeks of inspiratory muscle training
Measured: Evaluated in 12 weeks of inspiratory muscle training
Secondary outcomes (6)
Glucose in 8 weeks
Fasting plasma glucose concentration after 8 weeks of inspiratory muscle training.
Measured: Evaluated in 8 weeks of inspiratory muscle training
Glucose in 12 weeks
Fasting plasma glucose concentration after 12 weeks of inspiratory muscle training.
Measured: Evaluated in 12 weeks of inspiratory muscle training
Respiratory muscle strength in 8 weeks
Maximum respiratory muscle strength after 8 weeks of inspiratory muscle training, through the measurement of the maximal inspiratory pressure (MIP) and maximal expiratory pressure (MEP).
Measured: Evaluated in 8 weeks of inspiratory muscle training
Respiratory muscle strength in 12 weeks
Maximum respiratory muscle strength after 12 weeks of inspiratory muscle training, through the measurement of the maximal inspiratory pressure (MIP) and maximal expiratory pressure (MEP).
Measured: Evaluated in 12 weeks of inspiratory muscle training
Ventilatory muscle resistance
Muscular endurance ventilatory after 12 weeks of inspiratory muscle training, through analysis of the MIP.
Measured: Evaluated in 12 weeks of inspiratory muscle training
Lung functions
Capacity and volumes lung after 12 weeks of inspiratory muscle training.
Measured: Evaluated in 12 weeks of inspiratory muscle training
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Jun 2017
- Study start11 Jul 2017
- Primary completion31 Dec 2018 (estimated)
- Study completion31 Jan 2019 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Diabetes Mellitus, Type 2Studies of the same condition, open and under way.
- More trials run by Hospital de Clinicas de Porto AlegreThe sponsor's other registered studies.
- 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Parallel Randomized clinical trial
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Hospital de Clinicas de Porto Alegre
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Beatriz D'Agord Schaan, PhD, Principal investigator, Hospital de Clinicas de Porto Alegre
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03191435
- Sponsor's protocol ID
- 61986916.9.0000.5327
- Status last verified
- Aug 2017
- First submitted
- 15 Jun 2017
- Last updated
- 14 Aug 2017
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
Pinto MB, Bock PM, Schein ASO, Portes J, Monteiro RB, Schaan BD. Inspiratory Muscle Training on Glucose Control in Diabetes: A Randomized Clinical Trial. Int J Sport Nutr Exerc Metab. 2021 Jan 1;31(1):21-31. doi: 10.1123/ijsnem.2020-0175. Epub 2020 Nov 27.
PubMed 33248438
Study at a glance
From the registry record, last updated by the sponsor on 14 Aug 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Inspiratory Muscle Training on Glycemic Control in Individuals With Type 2 Diabetes:Randomized Clinical Trial
- ClinicalTrials.gov ID
- NCT03191435
- Acronym / sponsor ID
- 61986916.9.0000.5327
- Conditions
- Diabetes Mellitus, Type 2
- Keywords
- Diabetes mellitus, type 2, Inspiratory muscle training, Glycemic control, Glucose, Exercise, Diaphragm exercise, Inspiratory loading
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- Hospital de Clinicas de Porto AlegreUniversity, hospital or other
- Study start
- 11 Jul 2017 (actual)
- Primary completion
- 31 Dec 2018 (estimated)
- Study completion
- 31 Jan 2019 (estimated)
- First posted
- 19 Jun 2017 (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.
In diabetic individuals, changes in ventilatory muscle strength and lung function have been demonstrated over the years. The onset and progression of chronic complications in diabetes should be avoided by reaching glycated hemoglobin (HbA1c) levels below 7%. The control of glycemia through the measurement of HbA1c is fundamental to avoid complications. The inspiratory muscle training has been used in several clinical situations, and may be an alternative for individuals with type 2 diabetes mellitus who have difficulties performing conventional exercises. The long-term effect of inspiratory muscle training on glycemic control has not been tested yet. The aim of this study is to evaluate the effects of inspiratory muscle training on glycemic control in individuals with type 2 diabetes.
Detailed description
An acute high intensity inspiratory muscle exercise session was able to reduce glycemic levels (24%) similarly to an aerobic exercise session (25%) in subjects with type 2 diabetes, demonstrating that this type of exercise inspiratory muscle may have great potential in improving glycemic control.The present study will investigate if training of the inspiratory musculature for 8 and 12 weeks is capable of improving glycated hemoglobin, glucose and inspiratory muscle strength in individuals with type 2 diabetes. In addition, this study will evaluate the effect of inspiratory muscle training, with moderate loading of 30% of the MIP, on volumes and capacities lung in patients with type 2 diabetes. The subjects with type 2 diabetes will be recruited from the ambulatory of the Hospital de Clinicas de Porto Alegre and through newspaper advertisements.
Patients will be submitted to a general evaluation, including clinical history, physical examination, laboratory evaluation and application of the international physical activity questionnaire. Subsequently, individuals will perform assessments of lung functions (lung function assessment, ventilatory muscle strength test, inspiratory muscle strength test) and autonomic assessment (Ewing's tests). Patients will be randomized to perform inspiratory muscle training with a placebo load (MIP 2%) or with moderate intensity (MIP 30%). Upon the randomization, participants will initiate inspiratory musculature training. The exams of HbA1c, glucose and ventilatory muscle strength tests will be performed in three moments: 1) at the initial assessment, 2) in the eighth week of inspiratory muscle training, and 3) at the end of the training (twelfth) week. During inspiratory muscle training, individuals will attend on Hospital de Clinicas de Porto Alegre, once a week, to the supervision of the way the exercise is being performed. Furthermore, it will be set to load on the PowerBreathe ® device for the following week.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
- Model description
- Parallel Randomized clinical trial
| Arm | Type | Receives |
|---|---|---|
| Inspiratory muscle training | Experimental | Device: Inspiratory muscle training.Patients will perform the inspiratory muscle training using a load moderate of 30% of maximal inspiratory pressure (MIP 30%). |
| Placebo inspiratory muscle | Placebo comparator | Device: Placebo inspiratory musclePatients will perform the inspiratory muscle training using a load of 2% of maximal inspiratory pressure (MIP 2%). |
Who may qualify
- Ages
- 30 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Type 2 diabetes;
- 30 years and older;
- HbA1c from 7,5 to 10%.
Key exclusion criteria (6 listed)
- Pregnant women;
- Pulmonary disease (chronic obstructive pulmonary disease, exercise-induced asthma, idiopathic pulmonary fibrosis, sarcoidosis and lung neoplasms);
- Neuromuscular disease;
- Body mass index > 35 kg/m²;
- Individuals who perform physical exercise more than twice a week;
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 |
|---|---|---|
| Inspiratory muscle training.Patients will perform the inspiratory muscle training using a moderate load of 30% of maximal inspiratory pressure (MIP 30%). The training will be conducted at home in a period of 30 minutes, 7 times a week, during 12 weeks. During inspiratory muscle training, individuals will attend Hospital de Clinicas de Porto Alegre once a week to the supervision of the way the exercise is being performed. Furthermore, load in the device (powerbreathe) will be adjusted for the individual to use next week. | Device | Inspiratory muscle training |
| Placebo inspiratory musclePatients will perform the inspiratory muscle training using a very low load of 2% of maximal inspiratory pressure (MIP 2%). The training will be conducted at home in a period of 30 minutes, 7 times a week, in the course of 12 weeks. During inspiratory muscle training, individuals will attend Hospital de Clinicas de Porto Alegre once a week to the supervision of the way the exercise is being performed. | Device | Placebo inspiratory muscle |
Primary outcome
Glycated hemoglobin in 8 weeks
Time frame: Evaluated in 8 weeks of inspiratory muscle training
Glycated hemoglobin concentration after 8 weeks of inspiratory muscle training
Glycated hemoglobin in 12 weeks
Time frame: Evaluated in 12 weeks of inspiratory muscle training
Glycated hemoglobin concentration after 12 weeks of inspiratory muscle training
6 secondary outcomes
Glucose in 8 weeks
Time frame: Evaluated in 8 weeks of inspiratory muscle training
Glucose in 12 weeks
Time frame: Evaluated in 12 weeks of inspiratory muscle training
Respiratory muscle strength in 8 weeks
Time frame: Evaluated in 8 weeks of inspiratory muscle training
Respiratory muscle strength in 12 weeks
Time frame: Evaluated in 12 weeks of inspiratory muscle training
Ventilatory muscle resistance
Time frame: Evaluated in 12 weeks of inspiratory muscle training
Lung functions
Time frame: Evaluated in 12 weeks of inspiratory muscle training
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Aug 2017.
- Derived from this study: PubMed 33248438Pinto MB, Bock PM, Schein ASO, Portes J, Monteiro RB, Schaan BD. Inspiratory Muscle Training on Glucose Control in Diabetes: A Randomized Clinical Trial. Int J Sport Nutr Exerc Metab. 2021 Jan 1;31(1):21-31. doi: 10.1123/ijsnem.2020-0175. Epub 2020 Nov 27.
- Individual participant dataSharing planned: Undecided
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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.
Beatriz D'Agord Schaan, PhD principal investigator
Hospital de Clinicas de Porto Alegre
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Inspiratory muscle training. in people with Diabetes Mellitus, Type 2, run by Hospital de Clinicas de Porto Alegre at 1 site in Brazil.
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 3 inclusion and 6 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: status not confirmed, as of the sponsor's last update on 14 Aug 2017. 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 Brazil. 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. Some participants in this study may receive a placebo. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Beatriz D'Agord Schaan, PhD (55 51993138534, bschaan@hcpa.edu.br), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Glycated hemoglobin in 8 weeks (time frame: Evaluated in 8 weeks of inspiratory muscle training). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03191435, which also lists 1 linked publication.
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 14 Aug 2017.