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

Assaf-Harofeh Medical Center1 site in 1 country12 target enrollmentJuly 2014

ConditionsType 2 Diabetes Mellitus

Overview

Phase: N/A
Intervention: Not specified
Conditions: Type 2 Diabetes Mellitus
Sponsor: Assaf-Harofeh Medical Center
Enrollment: 12
Locations: 1
Primary Endpoint: Number of participants with hypoglycemia, and/ or adverse events that are related to treatment
Status: Completed
Last Updated: 9 years ago

Overview Investigators Eligibility Criteria Outcomes Sites Similar Trials

Overview

Brief Summary

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.

Registry

clinicaltrials.gov

Start Date

July 2014

End Date

June 2016

Last Updated

9 years ago

Study Type

Interventional

Study Design

Crossover

Sex

All

Investigators

Sponsor

Assaf-Harofeh Medical Center

Responsible Party

Sponsor

Eligibility Criteria

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

Outcomes

Primary Outcomes

Number of participants with hypoglycemia, and/ or adverse events that are related to treatment

Time Frame: Baseline through 2 months

Secondary Outcomes

Incidence of minor side effects related to treatment(Baseline through 2 months)
Changes in mean interstitial glucose levels measured by CGM(Baseline, 1, 2, 5, and 6 weeks)