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

Not Applicable

Completed

• Conditions: Type2 Diabetes Mellitus
• Interventions: Device: NMES-placebo; Device: NMES

• Registration Number: NCT03256747
• Lead Sponsor: Hospital de Clinicas de Porto Alegre

Brief 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 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.

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.

Study Timeline

• Study First Submitted: 2017-08-07
• Study First Submitted QC: 2017-08-17
• Study First Posted: 2017-08-22
• Study Start: 2017-09-15
• Primary Completion: 2020-03-30
• Study Completion: 2020-05-30
• Status Verified: 2020-07
• Last Update Submitted: 2020-07-31
• Last Update Posted: 2020-08-04

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 28

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
NMES-placebo group	NMES-placebo	NMES-placebo will be placed at the knee extensors, with minimal intensity to provide a sensory stimulus, but insufficient to elicit a tetanic muscular contraction.
NMES group	NMES	NMES will be placed at the knee extensors, with maximal intensity tolerance evaluated by to induce visible contractions.

Primary Outcome Measures

Name	Time	Method
Glucose levels	48 hours	Glucose levels will be assessed through continuous glucose monitoring (CGMS)

Secondary Outcome Measures

Name	Time	Method
Blood pressure	Each 5 minutes during intervention which will last 60 minutes.	Will be evaluated through non-invasive oscillometric device.
Glucose variability	48 hours	Glucose variability will be assessed by CGMS 24 hours before, during the protocol and 24 hours after protocol.
Heart Rate	Each 5 minutes during intervention which will last 60 minutes.	Will be evaluated through non-invasive oscillometric device.
Oxygenation tissue	Before, during and immediately after the intervention which will last 60 minutes.	Will be evaluated through near infrared spectroscopy (NIRS).

Trial Locations

Locations (1)

Aline C P Macedo; 🇧🇷 Porto Alegre, RS, Brazil