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

Type2 Diabetes Mellitus Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03256747
• Other study ID #: 68437417.0.0000.5327
• Status: Completed
• Phase: N/A
• Start date: September 15, 2017
• Est. completion date: May 30, 2020

Study information

• Verified date: July 2020
• Source: Hospital de Clinicas de Porto Alegre
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical 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 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 28
• Est. completion date: May 30, 2020
• Est. primary completion date: March 30, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 30 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Diabetes Mellitus
• Diabetes Mellitus, Type 2
• Type2 Diabetes Mellitus

Intervention

Device:
• NMES
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
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.

Locations

Country	Name	City	State
Brazil	Aline C P Macedo	Porto Alegre	RS

Sponsors (1)

Lead Sponsor	Collaborator
Hospital de Clinicas de Porto Alegre

Country where clinical trial is conducted

Brazil, 

References & Publications (8)

Brownlee M. The pathobiology of diabetic complications: a unifying mechanism. Diabetes. 2005 Jun;54(6):1615-25. — View Citation

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). pii: e000219. doi: 10.1136/bmjopen-2011-000219. Print 2012. — View Citation

Green S, Egaña 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. Review. — View Citation

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. — View Citation

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. — View Citation

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. Review. — View Citation

Standards of Medical Care in Diabetes-2017: Summary of Revisions. Diabetes Care. 2017 Jan;40(Suppl 1):S4-S5. Review. — View Citation

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Glucose levels	Glucose levels will be assessed through continuous glucose monitoring (CGMS)	48 hours
Secondary	Glucose variability	Glucose variability will be assessed by CGMS 24 hours before, during the protocol and 24 hours after protocol.	48 hours
Secondary	Blood pressure	Will be evaluated through non-invasive oscillometric device.	Each 5 minutes during intervention which will last 60 minutes.
Secondary	Heart Rate	Will be evaluated through non-invasive oscillometric device.	Each 5 minutes during intervention which will last 60 minutes.
Secondary	Oxygenation tissue	Will be evaluated through near infrared spectroscopy (NIRS).	Before, during and immediately after the intervention which will last 60 minutes.