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Weight Loss and Appetite Reduction After Percutaneous Electrical Stimulation Dermatome T6

NCT02810925 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 200

Last updated 2016-06-23

No results posted yet for this study

Summary

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.

Conditions

Interventions

PROCEDURE

PENS T6

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

PROCEDURE

TENS T11/T12

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

DIETARY_SUPPLEMENT

Hypocaloric 1200 Kcal/day diet

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

DIETARY_SUPPLEMENT

Normocaloric 2000 Kcal/day diet

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

Sponsors & Collaborators

  • Hospital General Universitario Elche

    lead OTHER

Principal Investigators

  • Dolores Castro · Clinica Garcilaso

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2015-07-31
Primary Completion
2015-12-31
Completion
2015-12-31

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Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02810925 on ClinicalTrials.gov