Clinical trial NCT03191435: Inspiratory Muscle Training on Glycemic Control in Individuals With Type 2 Diabetes
Official title: Effect of Inspiratory Muscle Training on Glycemic Control in Individuals With Type 2 Diabetes:Randomized Clinical Trial
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Diabetes Mellitus, Type 2
Keywords: Diabetes mellitus, type 2
Inspiratory muscle training
Glycemic control
Glucose
Exercise
Diaphragm exercise
Inspiratory loading
Lead sponsor: Hospital de Clinicas de Porto Alegre
Sponsor class: OTHER
First posted: 2017-06-19
Enrollment: 30
Sex: ALL
Minimum age (years): 30
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Parallel Randomized clinical trial
Primary purpose: TREATMENT

Brief 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%. 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.

Eligibility criteria: 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.

Primary outcomes:
measure: Glycated hemoglobin in 8 weeks
timeFrame: Evaluated in 8 weeks of inspiratory muscle training
measure: Glycated hemoglobin in 12 weeks
timeFrame: Evaluated in 12 weeks of inspiratory muscle training
Secondary outcomes:
measure: Glucose in 8 weeks
timeFrame: Evaluated in 8 weeks of inspiratory muscle training
measure: Glucose in 12 weeks
timeFrame: Evaluated in 12 weeks of inspiratory muscle training
measure: Respiratory muscle strength in 8 weeks
timeFrame: Evaluated in 8 weeks of inspiratory muscle training
measure: Respiratory muscle strength in 12 weeks
timeFrame: Evaluated in 12 weeks of inspiratory muscle training
measure: Ventilatory muscle resistance
timeFrame: Evaluated in 12 weeks of inspiratory muscle training
measure: Lung functions
timeFrame: Evaluated in 12 weeks of inspiratory muscle training
Other outcomes:
Locations:
city: Porto Alegre
country: Brazil
facility: Hospital de Clínicas de Porto Alegre
state: Rio grande do sul
Study officials:
affiliation: Hospital de Clinicas de Porto Alegre
name: Beatriz D'Agord Schaan, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.