Percutaneous Electroneurostimulation of Dermatome T6 for Appetite Reduction and Weight Loss in Morbidly Obese Patients

NCT ID: NCT01792947

Last Updated: 2013-02-15

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

60 participants

Study Classification

INTERVENTIONAL

Study Start Date

2012-06-30

Study Completion Date

2013-01-31

Brief Summary

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Based on the creation of a somato-autonomic reflex, the stimulation of sensory nerve terminals located in dermatome T6 may cause a reflex, whose efferent pathways end in vagal nerve branches stimulating the gastric wall, similarly to the gastric pacemaker.

The aim of this study was to evaluate the effect of percutaneous electroneurostimulation (PENS) of T6 dermatome on appetite, weight loss and dietary compliance.

Detailed Description

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Conditions

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Appetite Reduction Weight Loss

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Diet

Diet 1200 Kcal during 3 months

Group Type ACTIVE_COMPARATOR

Diet 1200 Kcal

Intervention Type BEHAVIORAL

The patients assigned to this group must follow a 1200 Kcal diet during months

PENS associated to diet

Percutaneous electroneurostimulation of dermatome T6 associated to diet 1200 Kcal

Group Type EXPERIMENTAL

Percutaneous electroneurostimulation of dermatome T6

Intervention Type PROCEDURE

The patients underwent a percutaneous electroneurostimulation of dermatome T6 during 30 minutes, every week during 12 weeks. This intervention was associated to a diet 1200 Kcal

Diet 1200 Kcal

Intervention Type BEHAVIORAL

The patients assigned to this group must follow a 1200 Kcal diet during months

Interventions

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Percutaneous electroneurostimulation of dermatome T6

The patients underwent a percutaneous electroneurostimulation of dermatome T6 during 30 minutes, every week during 12 weeks. This intervention was associated to a diet 1200 Kcal

Intervention Type PROCEDURE

Diet 1200 Kcal

The patients assigned to this group must follow a 1200 Kcal diet during months

Intervention Type BEHAVIORAL

Eligibility Criteria

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Inclusion Criteria

* patients candidates to bariatric surgery
* BMI \> 40 Kg/m2 or a BMI \> 35 Kg/m2 with comorbidities associated to the obesity status
* Failure of dietary treatment.

Exclusion Criteria

* untreated endocrine disease causing obesity
* serious psychiatric illness.
Minimum Eligible Age

18 Years

Maximum Eligible Age

65 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

Professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Jaime Ruiz-Tovar, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

General University Hospital Elche

Locations

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Hospital general Universitario de Elche

Elche, Alicante, Spain

Site Status

Countries

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Spain

References

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Ruiz-Tovar J, Oller I, Diez M, Zubiaga L, Arroyo A, Calpena R. Percutaneous electrical neurostimulation of dermatome T6 for appetite reduction and weight loss in morbidly obese patients. Obes Surg. 2014 Feb;24(2):205-11. doi: 10.1007/s11695-013-1091-z.

Reference Type DERIVED
PMID: 24122698 (View on PubMed)

Other Identifiers

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HGUE2013-1

Identifier Type: -

Identifier Source: org_study_id

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