- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02292810
Acute Effects of Inspiratory Muscle Exercise on Glucose Level and Glucose Variability in Patients With Type 2 Diabetes.
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
High-intensity exercise of inspiratory muscle was able to reduce glucose levels in previous studies, but the mechanisms underlying this reduction remain largely unknown. The present study will investigate this phenomenon, and whether confirmed, the inspiratory muscle loading would be a new approach for lowering glucose levels and glucose variability in type 2 diabetes.
The subjects with type 2 diabetes will be recruited from the ambulatory of the Hospital de Clinicas de Porto Alegre. The patients will be randomized to inspiratory muscle exercise with a high intensity load (MIP 60%) or to exercise with a load placebo (MIP 2%), on two different days. The subjects will come in the laboratory for three days consecutively during 2 weeks. On the first day will be placed the CGMS device. On the second day will be the controlled ventilation protocol with subsequently inspiratory muscle exercise, using 2% or 60% of MIP as randomized a priori. On the third day the CGMS will be removed. Individuals who are using beta-blockers will be advised to withdraw the medication 24 hours before the protocols. During all protocols will be recorded the continuous blood pressure to assess heart rate and blood pressure variabilities, both time and frequency domains will be analyzed. Also, the calf blood flow, inspiratory pressure, end-tidal carbon dioxide and oxygen saturation will be taking.
Study Type
Enrollment (Anticipated)
Phase
- Not Applicable
Contacts and Locations
Study Contact
- Name: Beatriz Schann, PhD
- Phone Number: 55513359 7640
- Email: beatrizschaan@gmail.com
Study Contact Backup
- Name: Andressa Schein, MSc
- Phone Number: 555193040101
- Email: andressasilveiradeoliveira@yahoo.com.br
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- Type 2 diabetes;
- HbA1c from 7,5 to 10%;
Exclusion Criteria:
- Subjects taking insulin;
- Pregnant women;
- Subjects taking betablocker only
- Documented arrythmia
- Documented fibrillation
- GFR<30
- Documented pulmonary disease or asthma,
- Current smoking;
- Varicose vein problems;
- Musculoskeletal disease.
Study Plan
How is the study designed?
Design Details
- Allocation: Randomized
- Interventional Model: Crossover Assignment
- Masking: Double
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Inspiratory muscle exercise
Patients will exercise the inspiratory muscle using a load of 60% of maximum inspiratory mouth pressure (MIP 60%).
|
For inspiratory muscle exercise patients will breathe with a high load of 60% of MIP using a respiratory frequency of 15 breaths min and a prolonged duty cycle (TI/TTOT =0.7) until task failure.
The blood flow, conductance and resistance arterial will be measured in the calf using plethysmography device.
Arterial blood pressure and heart rate will be monitored continuously at the finger on a beat-by-beat basis by biopac equipment and the glucose levels will be captured by continuous glucose monitoring system.
|
Placebo Comparator: Inspiratory muscle exercise placebo
Patients will exercise the inspiratory muscle using a load of 2% of maximum inspiratory mouth pressure (MIP 2%).
|
For inspiratory muscle exercise patients will breathe with a very low load of 2% of MIP using a respiratory frequency of 15 breaths min and a prolonged duty cycle (TI/TTOT =0.7) for 10 minute.
The blood flow, conductance and resistance arterial will be measured in the calf using plethysmography device.
Arterial blood pressure and heart rate will be monitored continuously at the finger on a beat-by-beat basis by biopac equipment and the glucose levels will be captured by using the continuous glucose monitoring system.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Glucose level
Time Frame: 1 day (A session of inspiratory muscle exercise)
|
The glucose level will be assessed by continuous glucose monitoring (CGMS) before and after exercise.
|
1 day (A session of inspiratory muscle exercise)
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Glucose variability
Time Frame: 3 days
|
The variability of the glucose will be assessed by continuous glucose monitoring (CGMS) 24 hours before exercise, during the protocol and 24 hours after exercise.
|
3 days
|
Autonomic control
Time Frame: 1 day (A session of inspiratory muscle exercise)
|
The autonomic control will be evaluated in the time domain and frequency through the Biopac.
|
1 day (A session of inspiratory muscle exercise)
|
Collaborators and Investigators
Investigators
- Principal Investigator: Beatriz Schaan, PhD, Hospital de Clinicas de Porto Alegre
Publications and helpful links
Study record dates
Study Major Dates
Study Start
Primary Completion (Anticipated)
Study Completion (Anticipated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Estimate)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 14-0194
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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