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Inspiratory Muscle Training on Glycemic Control in Individuals With Type 2 Diabetes

Primary Purpose

Diabetes Mellitus, Type 2

Status
Unknown status
Phase
Not Applicable
Locations
Brazil
Study Type
Interventional
Intervention
Inspiratory muscle training.
Placebo inspiratory muscle
Sponsored by
Hospital de Clinicas de Porto Alegre
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Diabetes Mellitus, Type 2 focused on measuring Diabetes mellitus, type 2, Inspiratory muscle training, Glycemic control, Glucose, Exercise, Diaphragm exercise, Inspiratory loading

Eligibility Criteria

30 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • Hospital de Clínicas de Porto AlegreRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

Inspiratory muscle training

Placebo inspiratory muscle

Arm Description

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 load of 2% of maximal inspiratory pressure (MIP 2%).

Outcomes

Primary Outcome Measures

Glycated hemoglobin in 8 weeks
Glycated hemoglobin concentration after 8 weeks of inspiratory muscle training
Glycated hemoglobin in 12 weeks
Glycated hemoglobin concentration after 12 weeks of inspiratory muscle training

Secondary Outcome Measures

Glucose in 8 weeks
Fasting plasma glucose concentration after 8 weeks of inspiratory muscle training.
Glucose in 12 weeks
Fasting plasma glucose concentration after 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).
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).
Ventilatory muscle resistance
Muscular endurance ventilatory after 12 weeks of inspiratory muscle training, through analysis of the MIP.
Lung functions
Capacity and volumes lung after 12 weeks of inspiratory muscle training.

Full Information

First Posted
June 15, 2017
Last Updated
August 11, 2017
Sponsor
Hospital de Clinicas de Porto Alegre
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1. Study Identification

Unique Protocol Identification Number
NCT03191435
Brief Title
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

2. Study Status

Record Verification Date
August 2017
Overall Recruitment Status
Unknown status
Study Start Date
July 11, 2017 (Actual)
Primary Completion Date
December 31, 2018 (Anticipated)
Study Completion Date
January 31, 2019 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Hospital de Clinicas de Porto Alegre

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Diabetes Mellitus, Type 2
Keywords
Diabetes mellitus, type 2, Inspiratory muscle training, Glycemic control, Glucose, Exercise, Diaphragm exercise, Inspiratory loading

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
Parallel Randomized clinical trial
Masking
ParticipantOutcomes Assessor
Allocation
Randomized
Enrollment
30 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Inspiratory muscle training
Arm Type
Experimental
Arm Description
Patients will perform the inspiratory muscle training using a load moderate of 30% of maximal inspiratory pressure (MIP 30%).
Arm Title
Placebo inspiratory muscle
Arm Type
Placebo Comparator
Arm Description
Patients will perform the inspiratory muscle training using a load of 2% of maximal inspiratory pressure (MIP 2%).
Intervention Type
Device
Intervention Name(s)
Inspiratory muscle training.
Intervention Description
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.
Intervention Type
Device
Intervention Name(s)
Placebo inspiratory muscle
Intervention Description
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.
Primary Outcome Measure Information:
Title
Glycated hemoglobin in 8 weeks
Description
Glycated hemoglobin concentration after 8 weeks of inspiratory muscle training
Time Frame
Evaluated in 8 weeks of inspiratory muscle training
Title
Glycated hemoglobin in 12 weeks
Description
Glycated hemoglobin concentration after 12 weeks of inspiratory muscle training
Time Frame
Evaluated in 12 weeks of inspiratory muscle training
Secondary Outcome Measure Information:
Title
Glucose in 8 weeks
Description
Fasting plasma glucose concentration after 8 weeks of inspiratory muscle training.
Time Frame
Evaluated in 8 weeks of inspiratory muscle training
Title
Glucose in 12 weeks
Description
Fasting plasma glucose concentration after 12 weeks of inspiratory muscle training.
Time Frame
Evaluated in 12 weeks of inspiratory muscle training
Title
Respiratory muscle strength in 8 weeks
Description
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).
Time Frame
Evaluated in 8 weeks of inspiratory muscle training
Title
Respiratory muscle strength in 12 weeks
Description
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).
Time Frame
Evaluated in 12 weeks of inspiratory muscle training
Title
Ventilatory muscle resistance
Description
Muscular endurance ventilatory after 12 weeks of inspiratory muscle training, through analysis of the MIP.
Time Frame
Evaluated in 12 weeks of inspiratory muscle training
Title
Lung functions
Description
Capacity and volumes lung after 12 weeks of inspiratory muscle training.
Time Frame
Evaluated in 12 weeks of inspiratory muscle training

10. Eligibility

Sex
All
Minimum Age & Unit of Time
30 Years
Accepts Healthy Volunteers
No
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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Beatriz D'Agord Schaan, PhD
Phone
55 51993138534
Email
bschaan@hcpa.edu.br
First Name & Middle Initial & Last Name or Official Title & Degree
Mariana Brutto de Pinto
Phone
55 51 981512270
Email
maribpinto@yahoo.com.br
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Beatriz D'Agord Schaan, PhD
Organizational Affiliation
Hospital de Clinicas de Porto Alegre
Official's Role
Principal Investigator
Facility Information:
Facility Name
Hospital de Clínicas de Porto Alegre
City
Porto Alegre
State/Province
Rio grande do sul
ZIP/Postal Code
90.035-903
Country
Brazil
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Beatriz D'agord Schaan, PhD
Email
bschaan@hcpa.edu.br

12. IPD Sharing Statement

Plan to Share IPD
Undecided
Citations:
PubMed Identifier
33248438
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.
Results Reference
derived

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Inspiratory Muscle Training on Glycemic Control in Individuals With Type 2 Diabetes

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