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

NCT ID: NCT02727790

Last Updated: 2016-06-07

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

12 participants

Study Classification

INTERVENTIONAL

Study Start Date

2014-07-31

Study Completion Date

2016-06-30

Brief Summary

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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.

Detailed Description

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Conditions

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Type 2 Diabetes Mellitus

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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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

Group Type EXPERIMENTAL

Stimulator

Intervention Type DEVICE

Control

Interstitial glucose will be monitored throughout the study using a FreeStyle Navigator (Abbott Diabetes Care, Alameda, CA) CGM System

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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Stimulator

Intervention Type DEVICE

Other Intervention Names

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BEAC Biomedical Intellistim BE-28TC

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

75 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Assaf-Harofeh Medical Center

OTHER_GOV

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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Assaf-Harofeh Medical Center

Ẕerifin, , Israel

Site Status

Countries

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Israel

References

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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.

Reference Type DERIVED
PMID: 27997608 (View on PubMed)

Other Identifiers

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HTA6446

Identifier Type: OTHER

Identifier Source: secondary_id

129/12

Identifier Type: -

Identifier Source: org_study_id

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