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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02727790
Recruitment Status : Completed
First Posted : April 5, 2016
Last Update Posted : June 7, 2016
Sponsor:
Information provided by (Responsible Party):
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.

Condition or disease Intervention/treatment Phase
Type 2 Diabetes Mellitus Device: Stimulator Not Applicable

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 12 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Effect of Short Peripheral Electrical Stimulation (PES) on Blood Glucose Lowering Action in Type 2 Diabetes Patients
Study Start Date : July 2014
Actual Primary Completion Date : June 2016
Actual Study Completion Date : June 2016

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Blood Sugar

Arm Intervention/treatment
Experimental: PES Treatment
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
Device: Stimulator
Other Name: BEAC Biomedical Intellistim BE-28TC

No Intervention: Control
Interstitial glucose will be monitored throughout the study using a FreeStyle Navigator (Abbott Diabetes Care, Alameda, CA) CGM System



Primary Outcome Measures :
  1. Number of participants with hypoglycemia, and/ or adverse events that are related to treatment [ Time Frame: Baseline through 2 months ]

Secondary Outcome Measures :
  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 ]


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 75 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02727790


Locations
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Israel
Assaf-Harofeh Medical Center
Zerifin, Israel, 70300
Sponsors and Collaborators
Assaf-Harofeh Medical Center

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Assaf-Harofeh Medical Center
ClinicalTrials.gov Identifier: NCT02727790    
Other Study ID Numbers: 129/12
HTA6446 ( Other Identifier: Israel: Ministry of Health )
First Posted: April 5, 2016    Key Record Dates
Last Update Posted: June 7, 2016
Last Verified: March 2016
Additional relevant MeSH terms:
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Diabetes Mellitus, Type 2
Diabetes Mellitus
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases