PENS T6 With Ambulatory Self-applied Patch vs Conventional Procedure

Study Overview
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Brief Summary
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A prospective randomized study, including moderately obese patients will be included. Patients will be randomized in 3 groups: PENS of dermatome T6 with an ambulatory self-applied patch + 1200Kcal/day diet PENS of dermatome T6 with conventional procedure + 1200Kcal/day diet Only 1200Kcal/day diet The effect on appetite and weight loss will be investigated.

Detailed Description
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A prospective randomized study, including moderately obese (BMI 30-39 Kg/m2) patients will be included. Patients will be randomized in 3 groups: PENS of dermatome T6 with an ambulatory self-applied patch + 1200Kcal/day diet PENS of dermatome T6 with conventional procedure (weekly stimulation in the Outpatient Clinic) + 1200Kcal/day diet Only 1200Kcal/day diet The effect on appetite and weight loss will be investigated.

Official Title
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Percutaneous Electrical Neurostimulation (PENS) of Dermatome T6 With an Ambulatory Self-applied Patch vs PENS of Dermatome T6 With Conventional Procedure: Effect on Appetite and Weight Loss in Moderately Obese Patients

Conditions
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Weight Loss

Intervention / Treatment
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* Procedure: Self-applied patch
* Procedure: Conventional procedure
* Dietary Supplement: 1200 Kcal/day diet


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Moderately obese patients (BMI 30-39 kg/m2) Exclusion Criteria: Endocrinological diseases causing obesity Heart pacemaker Previous bariatric procedure

Ages Eligible for Study
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Minimum Age: 18 Years

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: Self-applied patch<br>The patients will use a self-applied patch weekly for PENS of dermatome T6. A 1200 Kcal/day diet will be also prescribed. | Procedure: Self-applied patch<br>* An ambulatory self-applied patch will be placed weekly by the patients for PENS of dermatome T6.<br>Dietary Supplement: 1200 Kcal/day diet<br>* A 1200 Kcal/day diet will be prescribed.<br>|
| Active Comparator: Conventional procedure<br>The patient will attend weekly the Outpatient Clinic for receiving the PENS of dermatome T6. The procedure will be performed by the Medicine Doctor. A 1200 Kcal/day diet will be also prescribed. | Procedure: Conventional procedure<br>* PENS of dermatome T6 will be applied by the MD in the Outpatient Clinic.<br>Dietary Supplement: 1200 Kcal/day diet<br>* A 1200 Kcal/day diet will be prescribed.<br>|
| Other: 1200 Kcal/day diet<br>A 1200 Kcal/day diet will be also prescribed. | Dietary Supplement: 1200 Kcal/day diet<br>* A 1200 Kcal/day diet will be prescribed.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Appetite will be quantified with a visual analogic scale | Appetite will be quantified weekly during the 12 weeks of treatment. Appetite will be quantified with a visual analogic scale (0= absence of appetite, 10=uncontrollable appetite) | 12 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Weight loss | Appetite will be quantified weekly during the 12 weeks of treatment | 12 weeks | 
| Compliance will be evaluated by means of a food diary filled by the patients and evaluated by a nutritionist | The compliance with the 3 arms of treatment will be investigated. Diet complience will be evaluated by means of a food diary filled by the patients and evaluated by a nutritionist. | 12 weeks |