Weight Loss and Appetite Reduction After Percutaneous Electrical Stimulation Dermatome T6

Study Overview
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Brief Summary
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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
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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.

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

Conditions
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Weight Loss

Intervention / Treatment
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* Procedure: PENS T6
* Procedure: TENS T11/T12
* Dietary Supplement: Hypocaloric 1200 Kcal/day diet
* Dietary Supplement: Normocaloric 2000 Kcal/day diet


Participation Criteria
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Eligibility Criteria
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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.
Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: PENS T6 and 1200 Kcal/day diet<br>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<br>* Patients undergo percutaneous electrical stimulation of dermatome T6, weekly, during 12 weeks.<br>Dietary Supplement: Hypocaloric 1200 Kcal/day diet<br>* Patients follow a Hypocaloric 1200 Kcal/day diet during 12 weeks.<br>|
| Active Comparator: PENST6 + Normocaloric 2000 Kcal/day diet<br>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<br>* Patients undergo percutaneous electrical stimulation of dermatome T6, weekly, during 12 weeks.<br>Dietary Supplement: Normocaloric 2000 Kcal/day diet<br>* Patients follow a Normocaloric 2000 Kcal/day diet during 12 weeks.<br>|
| Placebo Comparator: TENS T11/ T12 + 1200 Kcal/day diet<br>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. | Procedure: TENS T11/T12<br>* Patients undergo transcutaneous electrical stimulation of dermatomes T11-T12, weekly, during 12 weeks.<br>Dietary Supplement: Hypocaloric 1200 Kcal/day diet<br>* Patients follow a Hypocaloric 1200 Kcal/day diet during 12 weeks.<br>|
| Active Comparator: 1200 Kcal/day diet<br>Patients follow only a hypocaloric 1200 Kcal/day diet. | Dietary Supplement: Hypocaloric 1200 Kcal/day diet<br>* Patients follow a Hypocaloric 1200 Kcal/day diet during 12 weeks.<br>|

What is the study measuring?
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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 |