Effect of Short Peripheral Electrical Stimulation (PES) on Blood Glucose
Not Applicable
Completed
- Conditions
- Type 2 Diabetes Mellitus
- 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
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
- 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 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
Trial Locations
- Locations (1)
Assaf-Harofeh Medical Center
🇮🇱Zerifin, Israel
Assaf-Harofeh Medical Center🇮🇱Zerifin, Israel