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Completed

NCT Number: NCT02727790

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

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.

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Key information

Conditions

Type 2 Diabetes Mellitus Diabetes Mellitus Diabetes Mellitus, Type 2 Endocrine System Diseases Glucose Metabolism Disorders Metabolic Diseases Nutritional and Metabolic Diseases

Age range

18 year–75 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Assaf-Harofeh Medical Center

Ẕerifin, 70300, Israel

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Stimulator

Device

Other names: BEAC Biomedical Intellistim BE-28TC

Primary outcomes

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

    Time frame: Baseline through 2 months

Secondary outcomes

  1. Incidence of minor side effects related to treatment

    Time frame: Baseline through 2 months

  2. Changes in mean interstitial glucose levels measured by CGM

    Time frame: Baseline, 1, 2, 5, and 6 weeks

Sponsors and collaborators

Lead sponsor

Assaf-Harofeh Medical Center

Other Gov

Registry information

Official study title

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

Important dates

Study start
2014
Primary completion
2016
Study completion
2016
First posted
Apr 5, 2016
Registry last updated
Jun 7, 2016

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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