Acute Effects of Inspiratory Muscle Exercise on Glucose Level and Glucose Variability in Patients With Type 2 Diabetes.

Diabetes Mellitus, Type 2 Clinical Trial

Official title:

Acute Effects of Inspiratory Muscle Exercise on Glucose Level and Glucose Variability in Patients With Type 2 Diabetes.

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT02292810
• Other study ID #: 14-0194
• Status: Not yet recruiting
• Phase: N/A
• First received: November 13, 2014
• Last updated: November 13, 2014
• Start date: November 2014
• Est. completion date: March 2016

Study information

• Verified date: November 2014
• Source: Hospital de Clinicas de Porto Alegre
• Contact: Beatriz Schann, PhD
• Phone: 55513359 7640
• Email: beatrizschaan[@]gmail.com
• Is FDA regulated: No
• Health authority: Brazil: National Committee of Ethics in Research
• Study type: Interventional

Clinical Trial Summary

Type 2 diabetes is associated with respiratory muscle weakness and autonomic neuropathy. The exercise of inspiratory muscles has been investigating in various clinical situations and may cause similar benefits as the conventional exercises. The assessment of glucose variability has been used as an alternative tool to evaluate the others mechanisms than the absolute values of glucose levels, special during the exercise. However, the effect of inspiratory muscle exercise on glucose levels and glucose variability is not clear yet. The aim of the proposed research is to evaluate the acute effects of inspiratory muscle exercise using a high load of 60% of MIP on glucose levels and glucose variability in patients with type 2 diabetes.

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 14
• Est. completion date: March 2016
• Est. primary completion date: December 2015
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 30 Years and older

Eligibility

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 Design

Allocation: Randomized, Intervention Model: Crossover Assignment, Masking: Double Blind (Investigator, Outcomes Assessor)

Related Conditions & MeSH terms

• Diabetes Mellitus, Type 2

Intervention

Device:
• Inspiratory muscle exercise
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.
• Inspiratory muscle exercise placebo
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.

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Hospital de Clinicas de Porto Alegre

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Glucose level	The glucose level will be assessed by continuous glucose monitoring (CGMS) before and after exercise.	1 day (A session of inspiratory muscle exercise)	No
Secondary	Glucose variability	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	No
Secondary	Autonomic control	The autonomic control will be evaluated in the time domain and frequency through the Biopac.	1 day (A session of inspiratory muscle exercise)	No