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

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.

Study Overview

• Status: Completed
• Conditions: Weight Loss
• Intervention / Treatment: Procedure: PENS T6; Dietary supplement: Hypocaloric 1200 Kcal/day diet; Dietary supplement: Normocaloric 2000 Kcal/day diet; Procedure: TENS T11/T12

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.

• Study Type: Interventional
• Enrollment (Actual): 200
• Phase: Phase 3

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult; Older Adult
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

4

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: 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.	Procedure: PENS T6; Patients undergo percutaneous electrical stimulation of dermatome T6, weekly, during 12 weeks.; Dietary supplement: Hypocaloric 1200 Kcal/day diet; Patients follow a Hypocaloric 1200 Kcal/day diet during 12 weeks.
Active Comparator: 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.	Procedure: PENS T6; Patients undergo percutaneous electrical stimulation of dermatome T6, weekly, during 12 weeks.; Dietary supplement: Normocaloric 2000 Kcal/day diet; Patients follow a Normocaloric 2000 Kcal/day diet during 12 weeks.
Placebo Comparator: 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.	Dietary supplement: Hypocaloric 1200 Kcal/day diet; Patients follow a Hypocaloric 1200 Kcal/day diet during 12 weeks.; Procedure: TENS T11/T12; Patients undergo transcutaneous electrical stimulation of dermatomes T11-T12, weekly, during 12 weeks.
Active Comparator: 1200 Kcal/day diet; Patients follow only a hypocaloric 1200 Kcal/day diet.	Dietary supplement: Hypocaloric 1200 Kcal/day diet; Patients follow a Hypocaloric 1200 Kcal/day diet during 12 weeks.

What is the study measuring?

Primary Outcome Measures

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

Collaborators and Investigators

• Sponsor: Hospital General Universitario Elche
• Investigators: Study Chair: Dolores Castro, Clinica Garcilaso

Study record dates

Study Major Dates

• Study Start: July 1, 2015
• Primary Completion (Actual): December 1, 2015
• Study Completion (Actual): December 1, 2015

Study Registration Dates

• First Submitted: June 21, 2016
• First Submitted That Met QC Criteria: June 21, 2016
• First Posted (Estimate): June 23, 2016

Study Record Updates

• Last Update Posted (Estimate): June 23, 2016
• Last Update Submitted That Met QC Criteria: June 21, 2016
• Last Verified: June 1, 2016

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Body Weight Changes; Weight Loss; Body Weight
• Other Study ID Numbers: ClinGarci 16-2

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: Yes
• IPD Plan Description: Data might be published in a journal, always preserving patients´ confidentiality.