Effect of Short Peripheral Electrical Stimulation (PES) on Blood Glucose

June 6, 2016 updated by: Assaf-Harofeh Medical Center

Effect of Short Peripheral Electrical Stimulation (PES) on Blood Glucose Lowering Action in Type 2 Diabetes Patients

The epidemic nature of type 2 diabetes mellitus, along with the downsides of current treatments, has raised the need for therapeutic alternatives. The aim of this study is to evaluate safety, tolerability, and the glucose-lowering effect of noninvasive peripheral electrical stimulation (PES) as an alternative treatment for diabetes.

Study Overview

Status

Completed

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

12

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

      • Zerifin, Israel, 70300
        • Assaf-Harofeh Medical Center

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 75 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Patients diagnosed with type II diabetes, for at least one year prior to randomization
  • Body mass index BMI < 35 Kg/m2
  • Stable glucose lowering drugs regimen for at least one month prior to randomization
  • Capable of giving informed consent

Exclusion Criteria:

  • Pregnancy, or nursing
  • 10< HbA1c < 6
  • Permanent pacemakers
  • Metal prosthesis
  • Resting blood pressure > 160/ 100 mmHg
  • Skin disease
  • Treatment with steroids or beta-blockers treatment with psychiatric medications

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Crossover Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: PES Treatment
Eligible patients will receive daily 5 min PES treatment for two weeks. Interstitial glucose will be monitored throughout the study using a FreeStyle Navigator (Abbott Diabetes Care, Alameda, CA) continuous glucose monitor (CGM) System
Other Names:
  • BEAC Biomedical Intellistim BE-28TC
No Intervention: Control
Interstitial glucose will be monitored throughout the study using a FreeStyle Navigator (Abbott Diabetes Care, Alameda, CA) CGM System

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Number of participants with hypoglycemia, and/ or adverse events that are related to treatment
Time Frame: Baseline through 2 months
Baseline through 2 months

Secondary Outcome Measures

Outcome Measure
Time Frame
Incidence of minor side effects related to treatment
Time Frame: Baseline through 2 months
Baseline through 2 months
Changes in mean interstitial glucose levels measured by CGM
Time Frame: Baseline, 1, 2, 5, and 6 weeks
Baseline, 1, 2, 5, and 6 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

July 1, 2014

Primary Completion (Actual)

June 1, 2016

Study Completion (Actual)

June 1, 2016

Study Registration Dates

First Submitted

February 28, 2016

First Submitted That Met QC Criteria

March 30, 2016

First Posted (Estimate)

April 5, 2016

Study Record Updates

Last Update Posted (Estimate)

June 7, 2016

Last Update Submitted That Met QC Criteria

June 6, 2016

Last Verified

March 1, 2016

More Information

Terms related to this study

Other Study ID Numbers

  • 129/12
  • HTA6446 (Other Identifier: Israel: Ministry of Health)

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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