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

NCT ID: NCT03256747

Last Updated: 2020-08-04

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 28 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2017-09-15
• Study Completion Date: 2020-05-30

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.

Conditions

Type2 Diabetes Mellitus

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

NMES group

NMES will be placed at the knee extensors, with maximal intensity tolerance evaluated by to induce visible contractions.

Group Type: EXPERIMENTAL

NMES

Intervention Type: 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 group

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.

Group Type: PLACEBO_COMPARATOR

NMES-placebo

Intervention Type: 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.

Interventions

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.

Intervention Type: DEVICE

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.

Intervention Type: DEVICE

Eligibility Criteria

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.

• Minimum Eligible Age: 30 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Hospital de Clinicas de Porto Alegre

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Beatriz D Schaan, PhD

Role: PRINCIPAL_INVESTIGATOR

HCPA

Locations

Aline C P Macedo

Porto Alegre, Rio Grande do Sul, Brazil

Countries

Brazil

References

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.

Reference Type: BACKGROUND

PMID: 10938048 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 15919781 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 21561372 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 27979887 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 25918732 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 20560163 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 22700835 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 25107502 (View on PubMed)

Other Identifiers

68437417.0.0000.5327

Identifier Type: -

Identifier Source: org_study_id