Weight Loss and Appetite Reduction After Percutaneous Electrical Stimulation Dermatome T6

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.

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Key information

Conditions

Weight Loss Body Weight Body Weight Changes Pathological Conditions, Signs and Symptoms Signs and Symptoms

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

PENS T6

Procedure

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

TENS T11/T12

Procedure

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

Hypocaloric 1200 Kcal/day diet

Dietary Supplement

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

Normocaloric 2000 Kcal/day diet

Dietary Supplement

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

Primary outcomes

Weight loss

Time frame: After 12 weeks of treatment

Weight loss will be evaluated after 12 weeks of treatment

Sponsors and collaborators

Lead sponsor

Hospital General Universitario Elche

Other

Registry information

Official study title

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

Important dates

Study start: 2015
Primary completion: 2015
Study completion: 2015
First posted: Jun 23, 2016
Registry last updated: Jun 23, 2016

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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