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

Phases

Phase 3

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT02810925

Enrollment

200

Registered

2016-06-23

Start date

2015-07-31

Completion date

2015-12-31

Last updated

2016-06-23

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Weight Loss

Brief 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.

Interventions

PROCEDUREPENS T6

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

PROCEDURETENS T11/T12

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

DIETARY_SUPPLEMENTHypocaloric 1200 Kcal/day diet

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

DIETARY_SUPPLEMENTNormocaloric 2000 Kcal/day diet

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

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

ALL

Healthy volunteers

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.

Design outcomes

Primary

Measure	Time frame	Description
Weight loss	After 12 weeks of treatment	Weight loss will be evaluated after 12 weeks of treatment

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026