Type 2 Diabetes Mellitus
Conditions
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.
Interventions
DEVICEStimulator
Sponsors
Assaf-Harofeh Medical Center
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 75 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Number of participants with hypoglycemia, and/ or adverse events that are related to treatment | Baseline through 2 months |
Secondary
| Measure | Time frame |
|---|---|
| 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 |
Countries
Israel
Outcome results
None listed