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Type2 Diabetes MellitusNCT03256747

Effects of Neuromuscular Electrical Stimulation on Glucose Variability in Patients With Type 2 Diabetes

A study testing NMES in people with Type2 Diabetes Mellitus, run by Hospital de Clinicas de Porto Alegre at 1 site in Brazil.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

In patients with type 2 diabetes mellitus (T2DM) chronic hyperglycemia is the main cause of complications, promoting several micro and macrovascular damages. In order to understand other mechanisms that could have an impact on the development of these diabetic complications, the assessment of glycemic variability have… Read more about this study

Who is it for?
Ages 30 years and older
Conditions the study is for
Type2 Diabetes Mellitus
What is being tested?
NMES
Type of treatment
Medical device
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
28 participants
Where
1 siteBrazil
Study dates
15 Sep 2017to 30 May 2020
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%;
  • Fasting plasma glucose lower to 250 mg/dL
  • Drug therapy maintained for at least one month before inclusion in the study.

Who cannot join

  • Insulin use;
  • Pregnancy;
  • Documented arrhythmia;
  • Unstable angina;
  • Chronic renal failure (GFR lower than 15 ml/min);
  • Varicose vein problems;
  • Clinical musculoskeletal disease.

Trial locations and contacts

1 site in 1 country.

Brazil1 site

  • Aline C P Macedo

    Porto Alegre, Rio Grande do Sul, 90570040

Other trials in Brazil

About this study

Official title: Effects of Neuromuscular Electrical Stimulation on Glucose Levels and Glucose Variability in Patients With Type 2 Diabetes: a Randomized Clinical Trial

In patients with type 2 diabetes mellitus (T2DM) chronic hyperglycemia is the main cause of complications, promoting several micro and macrovascular damages. In order to understand other mechanisms that could have an impact on the development of these diabetic complications, the assessment of glycemic variability have been widely used. Glucose control can be achieved with multiple interventions, including exercise training. Some individuals, however, especially those with autonomic neuropathy, can have exercise intolerance. In this context, physical therapy proposes neuromuscular electrical stimulation (NMES) as a therapeutic that has been applied in research and clinical practice as an alternative to the training of patients who cannot perform conventional exercise. In patients with T2DM, NMES was shown to improve glycemic control and insulin sensitivity, but quality of these trials is poor. In addition, the effects of NMES on glycemic variability of T2DM patients have not yet been reported. The aim of this study is to evaluate the effects of NMES on glucose levels and glucose variability in patients with T2DM.

Read the detailed description

Patients with T2DM will be recruited from outpatient clinic of the Hospital de Clinicas de Porto Alegre. Patients will be randomized to NMES session, with maximal intensity tolerance by to induce visible contractions or to NMES-placebo, with minimal intensity to provide a sensory stimulus, but insufficient to elicit a tetanic muscular contraction. Subjects will attend to research facility four times. On the first visit clinical, physical examination and autonomic evaluation (Ewing test) will be performed and a blood sample will be collected. On the second visit CGMS will be placed for glycemic variability evaluation. On the third visit NMES or NMES-placebo will be performed in a randomized way. On the fourth visit the CGMS will be removed. Blood pressure and heart rate will be evaluated during the protocol each 5 minutes and oxygenation tissue will be evaluated before, during and immediately after the protocol, through NIRS.

Being tested
NMES, NMES-placebo
Keywords
Diabetes Mellitus, Diabetes Mellitus, Type 2, Glucose Metabolism Disorders, Metabolic Diseases, Endocrine System Diseases
Medical subject headings
Diabetes Mellitus, Diabetes Mellitus, Type 2, Glucose Metabolism Disorders, Metabolic Diseases, Endocrine System Diseases

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • NMESDevice

    NMES will be placed at the knee extensors. Stimulation frequency will be 20 Hz. Pulse width will be 0.5 milliseconds and the contraction time will be 10 seconds (TON: 10s) with a 5-second rest interval (TOFF: 5s). Total time application will be 60 minutes. Intensity will be adjusted individually, taking into account the patient's ability to promote the full knee extension and comfort during contractions.

  • NMES-placeboDevice

    NMES-placebo will be placed at the knee extensors. Stimulation frequency will be 20 Hz. Pulse width will be 0.5 milliseconds and the contraction time will be 10 seconds (TON: 10s) with a 5-second rest interval (TOFF: 5s). Total time of application will be 60 minutes. Intensity will be adjusted with minimal intensity, utilized to provide a sensory stimulus, but insufficient to elicit a tetanic muscular contraction.

Study groups in NCT03256747
Study groupRoleWhat they receive
NMES groupExperimentalNMES will be placed at the knee extensors, with maximal intensity tolerance evaluated by to induce visible contractions.
Receives: Device: NMES
NMES-placebo groupPlacebo comparatorNMES-placebo will be placed at the knee extensors, with minimal intensity to provide a sensory stimulus, but insufficient to elicit a tetanic muscular contraction.
Receives: Device: NMES-placebo

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Glucose levels

    Glucose levels will be assessed through continuous glucose monitoring (CGMS)

    Measured: 48 hours

Secondary outcomes (4)

  1. Glucose variability

    Glucose variability will be assessed by CGMS 24 hours before, during the protocol and 24 hours after protocol.

    Measured: 48 hours

  2. Blood pressure

    Will be evaluated through non-invasive oscillometric device.

    Measured: Each 5 minutes during intervention which will last 60 minutes.

  3. Heart Rate

    Will be evaluated through non-invasive oscillometric device.

    Measured: Each 5 minutes during intervention which will last 60 minutes.

  4. Oxygenation tissue

    Will be evaluated through near infrared spectroscopy (NIRS).

    Measured: Before, during and immediately after the intervention which will last 60 minutes.

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted22 Aug 2017
  2. Study start15 Sep 2017
  3. Primary completion30 Mar 2020
  4. Study completion30 May 2020

Resources

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
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Single blind
Who is masked
Outcomes assessor
Enrolment
28 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03256747
Sponsor's protocol ID
68437417.0.0000.5327
Status last verified
Jul 2020
First submitted
7 Aug 2017
Last updated
4 Aug 2020
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Undecided

Publications

  • Stratton IM, Adler AI, Neil HA, Matthews DR, Manley SE, Cull CA, Hadden D, Turner RC, Holman RR. Association of glycaemia with macrovascular and microvascular complications of type 2 diabetes (UKPDS 35): prospective observational study. BMJ. 2000 Aug 12;321(7258):405-12. doi: 10.1136/bmj.321.7258.405.

    PubMed 10938048

  • Brownlee M. The pathobiology of diabetic complications: a unifying mechanism. Diabetes. 2005 Jun;54(6):1615-25. doi: 10.2337/diabetes.54.6.1615. No abstract available.

    PubMed 15919781

  • Monnier L, Wojtusciszyn A, Colette C, Owens D. The contribution of glucose variability to asymptomatic hypoglycemia in persons with type 2 diabetes. Diabetes Technol Ther. 2011 Aug;13(8):813-8. doi: 10.1089/dia.2011.0049. Epub 2011 May 11.

    PubMed 21561372

  • Standards of Medical Care in Diabetes-2017: Summary of Revisions. Diabetes Care. 2017 Jan;40(Suppl 1):S4-S5. doi: 10.2337/dc17-S003. No abstract available.

    PubMed 27979887

  • Green S, Egana M, Baldi JC, Lamberts R, Regensteiner JG. Cardiovascular control during exercise in type 2 diabetes mellitus. J Diabetes Res. 2015;2015:654204. doi: 10.1155/2015/654204. Epub 2015 Mar 30.

    PubMed 25918732

  • Sbruzzi G, Ribeiro RA, Schaan BD, Signori LU, Silva AM, Irigoyen MC, Plentz RD. Functional electrical stimulation in the treatment of patients with chronic heart failure: a meta-analysis of randomized controlled trials. Eur J Cardiovasc Prev Rehabil. 2010 Jun;17(3):254-60. doi: 10.1097/HJR.0b013e328339b5a2.

    PubMed 20560163

  • Crowe L, Caulfield B. Aerobic neuromuscular electrical stimulation--an emerging technology to improve haemoglobin A1c in type 2 diabetes mellitus: results of a pilot study. BMJ Open. 2012 Jun 14;2(3):e000219. doi: 10.1136/bmjopen-2011-000219. Print 2012.

    PubMed 22700835

  • Joubert M, Metayer L, Prevost G, Morera J, Rod A, Cailleux A, Parienti JJ, Reznik Y. Neuromuscular electrostimulation and insulin sensitivity in patients with type 2 diabetes: the ELECTRODIAB pilot study. Acta Diabetol. 2015 Apr;52(2):285-91. doi: 10.1007/s00592-014-0636-5. Epub 2014 Aug 9.

    PubMed 25107502

Questions about this trial

What is this clinical trial studying?

A study testing NMES in people with Type2 Diabetes Mellitus, run by Hospital de Clinicas de Porto Alegre at 1 site in Brazil.

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 4 inclusion and 7 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: finished, as of the sponsor's last update on 4 Aug 2020. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Brazil. Whether a site is taking part right now should be confirmed with that site. See every site.

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?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Glucose levels (time frame: 48 hours). 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 NCT03256747, which also lists 8 linked publications.

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 4 Aug 2020.

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