NCT02810925

Weight Loss and Appetite Reduction After Percutaneous Electrical Stimulation Dermatome T6

Weight Loss and Appetite Reduction and Their Correlation With Plasmatic Ghrelin Levels After Percutaneous Electrical Stimulation Dermatome T6 Associated With a Hypocaloric Diet

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 200 (actual)
• Sponsor: Hospital General Universitario Elche · Academic / Other
• Sex: All
• Age: —
• Healthy volunteers: Not accepted

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.

Detailed description

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

• Weight Loss

Interventions

Type	Name	Description
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.

Timeline

• Start date: 2015-07-01
• Primary completion: 2015-12-01
• Completion: 2015-12-01
• First posted: 2016-06-23
• Last updated: 2016-06-23