PENS T6 With Ambulatory Self-applied Patch vs Conventional Procedure

Phase 3

Completed

• Conditions: Weight Loss
• Interventions: Procedure: Conventional procedure; Procedure: Self-applied patch; Dietary Supplement: 1200 Kcal/day diet

• Registration Number: NCT02564627
• Lead Sponsor: Abdel Kadar Clinic

Brief Summary

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

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.

Study Timeline

• Study Start: 2015-07
• Status Verified: 2015-09
• Primary Completion: 2015-09
• Study Completion: 2015-09
• Study First Submitted: 2015-09-25
• Study First Submitted QC: 2015-09-30
• Last Update Submitted: 2015-09-30
• Study First Posted: 2015-10-01
• Last Update Posted: 2015-10-01

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 90

Inclusion Criteria

• Moderately obese patients (BMI 30-39 kg/m2)

Exclusion Criteria

• Endocrinological diseases causing obesity
• Heart pacemaker
• Previous bariatric procedure

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Conventional procedure	1200 Kcal/day diet	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.
Conventional procedure	Conventional procedure	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.
Self-applied patch	Self-applied patch	The patients will use a self-applied patch weekly for PENS of dermatome T6. A 1200 Kcal/day diet will be also prescribed.
Self-applied patch	1200 Kcal/day diet	The patients will use a self-applied patch weekly for PENS of dermatome T6. A 1200 Kcal/day diet will be also prescribed.
1200 Kcal/day diet	1200 Kcal/day diet	A 1200 Kcal/day diet will be also prescribed.

Primary Outcome Measures

Name	Time	Method
Appetite will be quantified with a visual analogic scale	12 weeks	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)

Secondary Outcome Measures

Name	Time	Method
Weight loss	12 weeks	Appetite will be quantified weekly during the 12 weeks of treatment
Compliance will be evaluated by means of a food diary filled by the patients and evaluated by a nutritionist	12 weeks	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.