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

Not Applicable

Completed

• Conditions: Type 2 Diabetes Mellitus
• Interventions: Device: Stimulator

• Registration Number: NCT02727790
• Lead Sponsor: Assaf-Harofeh Medical Center

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2014-07
• Study First Submitted: 2016-02-28
• Status Verified: 2016-03
• Study First Submitted QC: 2016-03-30
• Study First Posted: 2016-04-05
• Primary Completion: 2016-06
• Study Completion: 2016-06
• Last Update Submitted: 2016-06-06
• Last Update Posted: 2016-06-07

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 12

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
PES Treatment	Stimulator	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

Primary Outcome Measures

Name	Time	Method
Number of participants with hypoglycemia, and/ or adverse events that are related to treatment	Baseline through 2 months

Secondary Outcome Measures

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

Trial Locations

Locations (1)

Assaf-Harofeh Medical Center; 🇮🇱 Zerifin, Israel