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

Type 2 Diabetes Mellitus Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02727790
• Other study ID #: 129/12
• Secondary ID: HTA6446
• Status: Completed
• Phase: N/A
• First received: February 28, 2016
• Last updated: June 6, 2016
• Start date: July 2014
• Est. completion date: June 2016

Study information

• Verified date: March 2016
• Source: Assaf-Harofeh Medical Center
• Contact: n/a
• Is FDA regulated: No
• Health authority: Israel: Ministry of Health
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 12
• Est. completion date: June 2016
• Est. primary completion date: June 2016
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 75 Years

Eligibility

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

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Crossover Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Diabetes Mellitus, Type 2
• Type 2 Diabetes Mellitus

Intervention

Device:
• Stimulator

Locations

Country	Name	City	State
Israel	Assaf-Harofeh Medical Center	Zerifin

Sponsors (1)

Lead Sponsor	Collaborator
Assaf-Harofeh Medical Center

Country where clinical trial is conducted

Israel, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Number of participants with hypoglycemia, and/ or adverse events that are related to treatment		Baseline through 2 months	Yes
Secondary	Incidence of minor side effects related to treatment		Baseline through 2 months	No
Secondary	Changes in mean interstitial glucose levels measured by CGM		Baseline, 1, 2, 5, and 6 weeks	No