PENS T6 With Ambulatory Self-applied Patch vs Conventional Procedure

September 30, 2015 updated by: Abdel Kadar Clinic

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Actual)

90

Phase

  • Phase 3

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

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

Exclusion Criteria:

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

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

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: 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.
Procedure: Self-applied patch
An ambulatory self-applied patch will be placed weekly by the patients for PENS of dermatome T6.
Dietary supplement: 1200 Kcal/day diet
A 1200 Kcal/day diet will be prescribed.
Active Comparator: 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.
Dietary supplement: 1200 Kcal/day diet
A 1200 Kcal/day diet will be prescribed.
Procedure: Conventional procedure
PENS of dermatome T6 will be applied by the MD in the Outpatient Clinic.
Other: 1200 Kcal/day diet
A 1200 Kcal/day diet will be also prescribed.
Dietary supplement: 1200 Kcal/day diet
A 1200 Kcal/day diet will be prescribed.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Appetite will be quantified with a visual analogic scale
Time Frame: 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)
12 weeks

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Weight loss
Time Frame: 12 weeks
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
Time Frame: 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.
12 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Abdel Kadar Clinic

Investigators

  • Principal Investigator: Mohammed Abdel Kadar, Kadar Clinic

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

July 1, 2015

Primary Completion (Actual)

September 1, 2015

Study Completion (Actual)

September 1, 2015

Study Registration Dates

First Submitted

September 25, 2015

First Submitted That Met QC Criteria

September 30, 2015

First Posted (Estimate)

October 1, 2015

Study Record Updates

Last Update Posted (Estimate)

October 1, 2015

Last Update Submitted That Met QC Criteria

September 30, 2015

Last Verified

September 1, 2015

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • KC15-02

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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