- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03191435
Inspiratory Muscle Training on Glycemic Control in Individuals With Type 2 Diabetes
Effect of Inspiratory Muscle Training on Glycemic Control in Individuals With Type 2 Diabetes:Randomized Clinical Trial
Study Overview
Status
Conditions
Intervention / Treatment
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 Type
Enrollment (Anticipated)
Phase
- Not Applicable
Contacts and Locations
Study Contact
- Name: Beatriz D'Agord Schaan, PhD
- Phone Number: 55 51993138534
- Email: bschaan@hcpa.edu.br
Study Contact Backup
- Name: Mariana Brutto de Pinto
- Phone Number: 55 51 981512270
- Email: maribpinto@yahoo.com.br
Study Locations
-
-
Rio grande do sul
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Porto Alegre, Rio grande do sul, Brazil, 90.035-903
- Recruiting
- Hospital de Clinicas de Porto Alegre
-
Contact:
- Beatriz D'agord Schaan, PhD
- Email: bschaan@hcpa.edu.br
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- Type 2 diabetes;
- 30 years and older;
- HbA1c from 7,5 to 10%.
Exclusion Criteria:
- 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.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Double
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Inspiratory muscle training
Patients will perform the inspiratory muscle training using a load moderate of 30% of maximal inspiratory pressure (MIP 30%).
|
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 Comparator: Placebo inspiratory muscle
Patients will perform the inspiratory muscle training using a load of 2% of maximal inspiratory pressure (MIP 2%).
|
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.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Glycated hemoglobin in 8 weeks
Time Frame: Evaluated in 8 weeks of inspiratory muscle training
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Glycated hemoglobin concentration after 8 weeks of inspiratory muscle training
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Evaluated in 8 weeks of inspiratory muscle training
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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
|
Evaluated in 12 weeks of inspiratory muscle training
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Glucose in 8 weeks
Time Frame: Evaluated in 8 weeks of inspiratory muscle training
|
Fasting plasma glucose concentration after 8 weeks of inspiratory muscle training.
|
Evaluated in 8 weeks of inspiratory muscle training
|
Glucose in 12 weeks
Time Frame: Evaluated in 12 weeks of inspiratory muscle training
|
Fasting plasma glucose concentration after 12 weeks of inspiratory muscle training.
|
Evaluated in 12 weeks of inspiratory muscle training
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Respiratory muscle strength in 8 weeks
Time Frame: Evaluated in 8 weeks of inspiratory muscle training
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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).
|
Evaluated in 8 weeks of inspiratory muscle training
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Respiratory muscle strength in 12 weeks
Time Frame: Evaluated in 12 weeks of inspiratory muscle training
|
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).
|
Evaluated in 12 weeks of inspiratory muscle training
|
Ventilatory muscle resistance
Time Frame: Evaluated in 12 weeks of inspiratory muscle training
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Muscular endurance ventilatory after 12 weeks of inspiratory muscle training, through analysis of the MIP.
|
Evaluated in 12 weeks of inspiratory muscle training
|
Lung functions
Time Frame: Evaluated in 12 weeks of inspiratory muscle training
|
Capacity and volumes lung after 12 weeks of inspiratory muscle training.
|
Evaluated in 12 weeks of inspiratory muscle training
|
Collaborators and Investigators
Investigators
- Principal Investigator: Beatriz D'Agord Schaan, PhD, Hospital de Clinicas de Porto Alegre
Publications and helpful links
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Anticipated)
Study Completion (Anticipated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- 61986916.9.0000.5327
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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