- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02727790
Effect of Short Peripheral Electrical Stimulation (PES) on Blood Glucose
June 6, 2016 updated by: Assaf-Harofeh Medical Center
Effect of Short Peripheral Electrical Stimulation (PES) on Blood Glucose Lowering Action in Type 2 Diabetes Patients
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.
Study Overview
Study Type
Interventional
Enrollment (Actual)
12
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
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-
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Zerifin, Israel, 70300
- Assaf-Harofeh Medical Center
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years to 75 years (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
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 Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Crossover Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / 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
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Other Names:
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No Intervention: Control
Interstitial glucose will be monitored throughout the study using a FreeStyle Navigator (Abbott Diabetes Care, Alameda, CA) CGM System
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Number of participants with hypoglycemia, and/ or adverse events that are related to treatment
Time Frame: Baseline through 2 months
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Baseline through 2 months
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Secondary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Incidence of minor side effects related to treatment
Time Frame: Baseline through 2 months
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Baseline through 2 months
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Changes in mean interstitial glucose levels measured by CGM
Time Frame: Baseline, 1, 2, 5, and 6 weeks
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Baseline, 1, 2, 5, and 6 weeks
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Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
July 1, 2014
Primary Completion (Actual)
June 1, 2016
Study Completion (Actual)
June 1, 2016
Study Registration Dates
First Submitted
February 28, 2016
First Submitted That Met QC Criteria
March 30, 2016
First Posted (Estimate)
April 5, 2016
Study Record Updates
Last Update Posted (Estimate)
June 7, 2016
Last Update Submitted That Met QC Criteria
June 6, 2016
Last Verified
March 1, 2016
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 129/12
- HTA6446 (Other Identifier: Israel: Ministry of Health)
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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