NCT03256747

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
28

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Sep 2017

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

August 7, 2017

Completed
15 days until next milestone

First Posted

Study publicly available on registry

August 22, 2017

Completed
24 days until next milestone

Study Start

First participant enrolled

September 15, 2017

Completed
2.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 30, 2020

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

May 30, 2020

Completed
Last Updated

August 4, 2020

Status Verified

July 1, 2020

Enrollment Period

2.5 years

First QC Date

August 7, 2017

Last Update Submit

July 31, 2020

Conditions

Type2 Diabetes Mellitus

Keywords

Diabetes MellitusDiabetes Mellitus, Type 2Glucose Metabolism DisordersMetabolic DiseasesEndocrine System Diseases

Outcome Measures

Primary Outcomes (1)

  • Glucose levels

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

    48 hours

Secondary Outcomes (4)

  • Glucose variability

    48 hours

  • Blood pressure

    Each 5 minutes during intervention which will last 60 minutes.

  • Heart Rate

    Each 5 minutes during intervention which will last 60 minutes.

  • Oxygenation tissue

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

Study Arms (2)

NMES group

EXPERIMENTAL

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

Device: NMES

NMES-placebo group

PLACEBO COMPARATOR

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.

Device: NMES-placebo

Interventions

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 group
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.

NMES-placebo group

Eligibility Criteria

Age30 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Type 2 diabetes;
  • HbA1c from 7,5 to 10%;
  • Fasting plasma glucose lower to 250 mg/dL

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Aline C P Macedo

Porto Alegre, Rio Grande do Sul, 90570040, Brazil

Location

Related Publications (8)

  • 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.

    PMID: 10938048BACKGROUND

  • 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.

    PMID: 15919781BACKGROUND

  • 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.

    PMID: 21561372BACKGROUND

  • 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.

    PMID: 27979887BACKGROUND

  • 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.

    PMID: 25918732BACKGROUND

  • 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.

    PMID: 20560163BACKGROUND

  • 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.

    PMID: 22700835BACKGROUND

  • 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.

    PMID: 25107502BACKGROUND

MeSH Terms

Conditions

Diabetes MellitusDiabetes Mellitus, Type 2Glucose Metabolism DisordersMetabolic DiseasesEndocrine System Diseases

Condition Hierarchy (Ancestors)

Nutritional and Metabolic Diseases

Study Officials

  • Beatriz D Schaan, PhD

    HCPA

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Masking Details
GCMS record will be coded and analyzed by a blinded investigator
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

August 7, 2017

First Posted

August 22, 2017

Study Start

September 15, 2017

Primary Completion

March 30, 2020

Study Completion

May 30, 2020

Last Updated

August 4, 2020

Record last verified: 2020-07

Locations

BR(1)