NCT02292810

Brief 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.

Trial Health

35
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
14

participants targeted

Target at below P25 for not_applicable diabetes-mellitus-type-2

Timeline
Completed

Started Nov 2014

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

November 1, 2014

Completed
12 days until next milestone

First Submitted

Initial submission to the registry

November 13, 2014

Completed
4 days until next milestone

First Posted

Study publicly available on registry

November 17, 2014

Completed
1 year until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2015

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2016

Completed
Last Updated

November 17, 2014

Status Verified

November 1, 2014

Enrollment Period

1.1 years

First QC Date

November 13, 2014

Last Update Submit

November 13, 2014

Conditions

Diabetes Mellitus, Type 2

Outcome Measures

Primary Outcomes (1)

  • 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)

Secondary Outcomes (2)

  • Glucose variability

    3 days

  • Autonomic control

    1 day (A session of inspiratory muscle exercise)

Study Arms (2)

Inspiratory muscle exercise

EXPERIMENTAL

Patients will exercise the inspiratory muscle using a load of 60% of maximum inspiratory mouth pressure (MIP 60%).

Device: Inspiratory muscle exercise

Inspiratory muscle exercise placebo

PLACEBO COMPARATOR

Patients will exercise the inspiratory muscle using a load of 2% of maximum inspiratory mouth pressure (MIP 2%).

Device: Inspiratory muscle exercise placebo

Interventions

Inspiratory muscle exerciseDEVICE

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
Inspiratory muscle exercise placeboDEVICE

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.

Inspiratory muscle exercise placebo

Eligibility Criteria

Age30 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Type 2 diabetes;
  • HbA1c from 7,5 to 10%;

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Related Publications (1)

  • Schein A, Correa A, Casali KR, Schaan BD. Are glucose levels, glucose variability and autonomic control influenced by inspiratory muscle exercise in patients with type 2 diabetes? Study protocol for a randomized controlled trial. Trials. 2016 Jan 20;17:38. doi: 10.1186/s13063-016-1156-0.

    PMID: 26790405DERIVED

MeSH Terms

Conditions

Diabetes Mellitus, Type 2

Condition Hierarchy (Ancestors)

Diabetes MellitusGlucose Metabolism DisordersMetabolic DiseasesNutritional and Metabolic DiseasesEndocrine System Diseases

Study Officials

  • Beatriz Schaan, PhD

    Hospital de Clinicas de Porto Alegre

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Beatriz Schann, PhD

CONTACT

55513359 7640beatrizschaan@gmail.com

Andressa Schein, MSc

CONTACT

555193040101andressasilveiradeoliveira@yahoo.com.br

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
INVESTIGATOR, OUTCOMES ASSESSOR
Intervention Model
CROSSOVER
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

November 13, 2014

First Posted

November 17, 2014

Study Start

November 1, 2014

Primary Completion

December 1, 2015

Study Completion

March 1, 2016

Last Updated

November 17, 2014

Record last verified: 2014-11