Effect of Short Peripheral Electrical Stimulation (PES) on Blood Glucose
Primary Purpose
Type 2 Diabetes Mellitus
Status
Completed
Phase
Not Applicable
Locations
Israel
Study Type
Interventional
Intervention
Stimulator
Sponsored by
About this trial
This is an interventional treatment trial for Type 2 Diabetes Mellitus
Eligibility 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
Sites / Locations
- Assaf-Harofeh Medical Center
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
No Intervention
Arm Label
PES Treatment
Control
Arm Description
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
Interstitial glucose will be monitored throughout the study using a FreeStyle Navigator (Abbott Diabetes Care, Alameda, CA) CGM System
Outcomes
Primary Outcome Measures
Number of participants with hypoglycemia, and/ or adverse events that are related to treatment
Secondary Outcome Measures
Incidence of minor side effects related to treatment
Changes in mean interstitial glucose levels measured by CGM
Full Information
NCT ID
NCT02727790
First Posted
February 28, 2016
Last Updated
June 6, 2016
Sponsor
Assaf-Harofeh Medical Center
1. Study Identification
Unique Protocol Identification Number
NCT02727790
Brief Title
Effect of Short Peripheral Electrical Stimulation (PES) on Blood Glucose
Official Title
Effect of Short Peripheral Electrical Stimulation (PES) on Blood Glucose Lowering Action in Type 2 Diabetes Patients
Study Type
Interventional
2. Study Status
Record Verification Date
March 2016
Overall Recruitment Status
Completed
Study Start Date
July 2014 (undefined)
Primary Completion Date
June 2016 (Actual)
Study Completion Date
June 2016 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Assaf-Harofeh Medical Center
4. Oversight
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Type 2 Diabetes Mellitus
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Crossover Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
12 (Actual)
8. Arms, Groups, and Interventions
Arm Title
PES Treatment
Arm Type
Experimental
Arm Description
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
Arm Title
Control
Arm Type
No Intervention
Arm Description
Interstitial glucose will be monitored throughout the study using a FreeStyle Navigator (Abbott Diabetes Care, Alameda, CA) CGM System
Intervention Type
Device
Intervention Name(s)
Stimulator
Other Intervention Name(s)
BEAC Biomedical Intellistim BE-28TC
Primary Outcome Measure Information:
Title
Number of participants with hypoglycemia, and/ or adverse events that are related to treatment
Time Frame
Baseline through 2 months
Secondary Outcome Measure Information:
Title
Incidence of minor side effects related to treatment
Time Frame
Baseline through 2 months
Title
Changes in mean interstitial glucose levels measured by CGM
Time Frame
Baseline, 1, 2, 5, and 6 weeks
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
Eligibility 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
Facility Information:
Facility Name
Assaf-Harofeh Medical Center
City
Zerifin
ZIP/Postal Code
70300
Country
Israel
12. IPD Sharing Statement
Citations:
PubMed Identifier
27997608
Citation
Catalogna M, Doenyas-Barak K, Sagi R, Abu-Hamad R, Nevo U, Ben-Jacob E, Efrati S. Effect of Peripheral Electrical Stimulation (PES) on Nocturnal Blood Glucose in Type 2 Diabetes: A Randomized Crossover Pilot Study. PLoS One. 2016 Dec 20;11(12):e0168805. doi: 10.1371/journal.pone.0168805. eCollection 2016.
Results Reference
derived
Learn more about this trial
Effect of Short Peripheral Electrical Stimulation (PES) on Blood Glucose
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