Diabetes Mellitus, Type 2NCT02292810
Acute Effects of Inspiratory Muscle Exercise on Glucose Level and Glucose Variability in Patients With Type 2 Diabetes.
A study testing Inspiratory muscle exercise in people with Diabetes Mellitus, Type 2, run by Hospital de Clinicas de Porto Alegre.
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. Read more about this study
- Who is it for?
- Ages 30 years and older
- Conditions the study is for
- Diabetes Mellitus, Type 2
- What is being tested?
- Inspiratory muscle exercise
- Type of treatment
- Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 14 participants
- Where
- No sites listed yet
- Study dates
- Nov 2014to Mar 2016
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 30 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Type 2 diabetes;
- HbA1c from 7,5 to 10%;
Who cannot join
- Subjects taking insulin;
- Pregnant women;
- Subjects taking betablocker only
- Documented arrythmia
- Documented fibrillation
- GFR<30
Show all 10Show fewer
- Documented pulmonary disease or asthma,
- Current smoking;
- Varicose vein problems;
- Musculoskeletal disease.
Trial locations and contacts
No sites are listed yet.
About this study
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.
Read the 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.
- Conditions
- Diabetes Mellitus, Type 2
- Being tested
- Inspiratory muscle exercise, Inspiratory muscle exercise placebo
- Medical subject headings
- Diabetes Mellitus, Type 2
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
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 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.
| Study group | Role | What they receive |
|---|---|---|
| Inspiratory muscle exercise | Experimental | Patients will exercise the inspiratory muscle using a load of 60% of maximum inspiratory mouth pressure (MIP 60%). Receives: 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%). Receives: Device: Inspiratory muscle exercise placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Glucose level
The glucose level will be assessed by continuous glucose monitoring (CGMS) before and after exercise.
Measured: 1 day (A session of inspiratory muscle exercise)
Secondary outcomes (2)
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.
Measured: 3 days
Autonomic control
The autonomic control will be evaluated in the time domain and frequency through the Biopac.
Measured: 1 day (A session of inspiratory muscle exercise)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Nov 2014 (estimated)
- Study startNov 2014
- Primary completionDec 2015 (estimated)
- Study completionMar 2016 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Diabetes Mellitus, Type 2Studies of the same condition, open and under way.
- More trials run by Hospital de Clinicas de Porto AlegreThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind
- Who is masked
- Investigator, Outcomes assessor
- Enrolment
- 14 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Hospital de Clinicas de Porto Alegre
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Beatriz Schaan, PhD, Principal investigator, Hospital de Clinicas de Porto Alegre
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02292810
- Sponsor's protocol ID
- 14-0194
- Status last verified
- Nov 2014
- First submitted
- 13 Nov 2014
- Last updated
- 17 Nov 2014
- Results posted
- No
- Data monitoring committee
- No
Publications
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.
PubMed 26790405
Study at a glance
From the registry record, last updated by the sponsor on 17 Nov 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Acute Effects of Inspiratory Muscle Exercise on Glucose Level and Glucose Variability in Patients With Type 2 Diabetes.
- ClinicalTrials.gov ID
- NCT02292810
- Acronym / sponsor ID
- 14-0194
- Conditions
- Diabetes Mellitus, Type 2
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 14 participants (estimated)
- Lead sponsor
- Hospital de Clinicas de Porto AlegreUniversity, hospital or other
- Study start
- Nov 2014
- Primary completion
- Dec 2015 (estimated)
- Study completion
- Mar 2016 (estimated)
- First posted
- 17 Nov 2014 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind (investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Inspiratory muscle exercise | Experimental | Device: Inspiratory muscle exercisePatients will exercise the inspiratory muscle using a load of 60% of maximum inspiratory mouth pressure (MIP 60%). |
| Inspiratory muscle exercise placebo | Placebo comparator | Device: Inspiratory muscle exercise placeboPatients will exercise the inspiratory muscle using a load of 2% of maximum inspiratory mouth pressure (MIP 2%). |
Who may qualify
- Ages
- 30 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Type 2 diabetes;
- HbA1c from 7,5 to 10%;
Key exclusion criteria (10 listed)
- Subjects taking insulin;
- Pregnant women;
- Subjects taking betablocker only
- Documented arrythmia
- Documented fibrillation
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Inspiratory muscle exerciseFor 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. | Device | Inspiratory muscle exercise |
| Inspiratory muscle exercise placeboFor 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. | Device | Inspiratory muscle exercise placebo |
Primary outcome
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.
2 secondary outcomes
Glucose variability
Time frame: 3 days
Autonomic control
Time frame: 1 day (A session of inspiratory muscle exercise)
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Nov 2014.
- Derived from this study: PubMed 26790405Schein 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Beatriz Schaan, PhD principal investigator
Hospital de Clinicas de Porto Alegre
Questions about this trial
What is this clinical trial studying?
A study testing Inspiratory muscle exercise in people with Diabetes Mellitus, Type 2, run by Hospital de Clinicas de Porto Alegre.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 17 Nov 2014. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Beatriz Schann, PhD (55513359 7640, beatrizschaan@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Glucose level (time frame: 1 day (A session of inspiratory muscle exercise)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02292810, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 Nov 2014.