Weight Loss and Appetite Reduction After Percutaneous Electrical Stimulation Dermatome T6

NCT ID: NCT02810925

Last Updated: 2016-06-23

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

200 participants

Study Classification

INTERVENTIONAL

Study Start Date

2015-07-31

Study Completion Date

2015-12-31

Brief Summary

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The patients are randomized into 4 groups : Patients undergoing PENS of dermatome T6 in and a 1200 Kcal diet (Group 1), Patients undergoing PENS T6 and a 2000 Kcal/day, Patients undergoing transcutaneous electrical neurostimulation (TENS) of Dermatomes T11-T12 and following a 1200 Kcal diet and those patients following only a 1200 Kcal diet (Group 4). Weight loss, appetite and ghrelin levels at baseline and after treatment are investigated.

Detailed Description

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The patients were randomized into 4 groups using an Internet randomization module: Patients undergoing PENS of dermatome T6 in conjunction with the implementation of a 1200 Kcal diet (Group 1), Patients undergoing PENS T6 and following a normocaloric diet (2000 Kcal/day) (Group 2), Patients undergoing transcutaneous electrical neurostimulation (TENS) of dermatomes in right iliac fossa (Dermatomes T11-T12) and following a hypocaloric diet (1200 Kcal/day) (Group 3) and those patients following only a 1200 Kcal diet (Group 4).

Weight loss, appetite and ghrelin levels, at baseline and after treatment, are investigated.

Conditions

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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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PENS T6 and 1200 Kcal/day diet

Patients undergo 12 sessions of percutaneous electrical stimulation of dermatome T6 (PENS T6), weekly, during 12 weeks. During this period they follow a hypocaloric 1200 Kcal/day diet.

Group Type EXPERIMENTAL

PENS T6

Intervention Type PROCEDURE

Patients undergo percutaneous electrical stimulation of dermatome T6, weekly, during 12 weeks.

Hypocaloric 1200 Kcal/day diet

Intervention Type DIETARY_SUPPLEMENT

Patients follow a Hypocaloric 1200 Kcal/day diet during 12 weeks.

PENST6 + Normocaloric 2000 Kcal/day diet

Patients undergo 12 sessions of percutaneous electrical stimulation of dermatome T6 (PENS T6), weekly, during 12 weeks. During this period they follow a normocaloric 2000 Kcal/day diet.

Group Type ACTIVE_COMPARATOR

PENS T6

Intervention Type PROCEDURE

Patients undergo percutaneous electrical stimulation of dermatome T6, weekly, during 12 weeks.

Normocaloric 2000 Kcal/day diet

Intervention Type DIETARY_SUPPLEMENT

Patients follow a Normocaloric 2000 Kcal/day diet during 12 weeks.

TENS T11/ T12 + 1200 Kcal/day diet

Patients undergo 12 sessions of transcutaneous electrical stimulation of dermatomes T11-T12 , weekly, during 12 weeks. During this period they follow a hypocaloric 1200 Kcal/day diet.

Group Type PLACEBO_COMPARATOR

TENS T11/T12

Intervention Type PROCEDURE

Patients undergo transcutaneous electrical stimulation of dermatomes T11-T12, weekly, during 12 weeks.

Hypocaloric 1200 Kcal/day diet

Intervention Type DIETARY_SUPPLEMENT

Patients follow a Hypocaloric 1200 Kcal/day diet during 12 weeks.

1200 Kcal/day diet

Patients follow only a hypocaloric 1200 Kcal/day diet.

Group Type ACTIVE_COMPARATOR

Hypocaloric 1200 Kcal/day diet

Intervention Type DIETARY_SUPPLEMENT

Patients follow a Hypocaloric 1200 Kcal/day diet during 12 weeks.

Interventions

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PENS T6

Patients undergo percutaneous electrical stimulation of dermatome T6, weekly, during 12 weeks.

Intervention Type PROCEDURE

TENS T11/T12

Patients undergo transcutaneous electrical stimulation of dermatomes T11-T12, weekly, during 12 weeks.

Intervention Type PROCEDURE

Hypocaloric 1200 Kcal/day diet

Patients follow a Hypocaloric 1200 Kcal/day diet during 12 weeks.

Intervention Type DIETARY_SUPPLEMENT

Normocaloric 2000 Kcal/day diet

Patients follow a Normocaloric 2000 Kcal/day diet during 12 weeks.

Intervention Type DIETARY_SUPPLEMENT

Eligibility Criteria

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Inclusion Criteria

* Patients with obesity (BMI\>30 Kg/m2) or overweight (BMI 25-30 Kg/m2)

Exclusion Criteria

* Untreated endocrine disease causing obesity
* Serious psychiatric illness.
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

Head of Neurostimulation Unit. Garcilaso Clinic

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Dolores Castro

Role: STUDY_CHAIR

Clinica Garcilaso

Other Identifiers

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ClinGarci 16-2

Identifier Type: -

Identifier Source: org_study_id

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