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NCT Number: NCT03256747

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

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.

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Key information

Conditions

Type2 Diabetes Mellitus Diabetes Mellitus Diabetes Mellitus, Type 2 Endocrine System Diseases Glucose Metabolism Disorders Metabolic Diseases Nutritional and Metabolic Diseases

Age range

30 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Aline C P Macedo

Porto Alegre, Rio Grande do Sul, 90570040, Brazil

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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.

Exclusion criteria

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

Treatment and study plan

NMES

Device

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-placebo

Device

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.

Primary outcomes

  1. Glucose levels

    Time frame: 48 hours

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

Secondary outcomes

  1. Glucose variability

    Time frame: 48 hours

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

  2. Blood pressure

    Time frame: Each 5 minutes during intervention which will last 60 minutes.

    Will be evaluated through non-invasive oscillometric device.

  3. Heart Rate

    Time frame: Each 5 minutes during intervention which will last 60 minutes.

    Will be evaluated through non-invasive oscillometric device.

  4. Oxygenation tissue

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

    Will be evaluated through near infrared spectroscopy (NIRS).

Sponsors and collaborators

Lead sponsor

Hospital de Clinicas de Porto Alegre

Other

Registry information

Official study title

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

Important dates

Study start
2017
Primary completion
2020
Study completion
2020
First posted
Aug 22, 2017
Registry last updated
Aug 4, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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