Percutaneous Electric Neurostimulation of Dermatome T7 Improves Glycemic Profile in Obese and Typo 2 Diabetic Patients

NCT ID: NCT02122874

Last Updated: 2014-04-25

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

PHASE3

Total Enrollment

60 participants

Study Classification

INTERVENTIONAL

Study Start Date

2013-01-31

Study Completion Date

2014-04-30

Brief Summary

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Percutaneous neurostimulation of dermatome T7 increases Insulin segregation by the apancreas and improves glycemic profile in diabetic patients

Detailed Description

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Conditions

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Diabetes Mellitus Type 2 in Obese Type 2 Diabetes Mellitus With Features of Insulin Resistance

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Investigators

Study Groups

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Diet

The patients follow only a 1200 Kcal diet

Group Type ACTIVE_COMPARATOR

Percutaneous Neurostimulation (PENS) of dermatome T7

Intervention Type DEVICE

The patients undergo PENS of dermatome T7 and follow a 1200 Kcal diet

1200 Kcal diet

Intervention Type OTHER

Diet +PENS dermatome T7

The patients undergo PENS of dermatome T7 and follow a 1200 Kcal diet

Group Type EXPERIMENTAL

Percutaneous Neurostimulation (PENS) of dermatome T7

Intervention Type DEVICE

The patients undergo PENS of dermatome T7 and follow a 1200 Kcal diet

Interventions

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Percutaneous Neurostimulation (PENS) of dermatome T7

The patients undergo PENS of dermatome T7 and follow a 1200 Kcal diet

Intervention Type DEVICE

1200 Kcal diet

Intervention Type OTHER

Eligibility Criteria

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Inclusion Criteria

* BMI\>30 Kg/m2
* Type 2 diabetes mellitus
* Treatment with Metformin

Exclusion Criteria

* Under insulin treatment
* Endocrinological disorders causing diabetes mellitus
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Hospital General Universitario Elche

OTHER

Sponsor Role lead

Responsible Party

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Jaime Ruiz-Tovar, MD, PhD

MD, PhD

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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General Hospital Elche

Elche, Alicante, Spain

Site Status

Countries

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Spain

Other Identifiers

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2014-003

Identifier Type: -

Identifier Source: org_study_id

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