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OpenTrials
Completed

NCT Number: NCT02564627

PENS T6 With Ambulatory Self-applied Patch vs Conventional Procedure

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.

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Key information

Conditions

Weight Loss Body Weight Body Weight Changes Pathological Conditions, Signs and Symptoms Signs and Symptoms

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

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

Exclusion criteria

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

Treatment and study plan

Self-applied patch

Procedure

An ambulatory self-applied patch will be placed weekly by the patients for PENS of dermatome T6.

Conventional procedure

Procedure

PENS of dermatome T6 will be applied by the MD in the Outpatient Clinic.

1200 Kcal/day diet

Dietary Supplement

A 1200 Kcal/day diet will be prescribed.

Primary outcomes

  1. 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)

Secondary outcomes

  1. Weight loss

    Time frame: 12 weeks

    Appetite will be quantified weekly during the 12 weeks of treatment

  2. 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.

Sponsors and collaborators

Lead sponsor

Abdel Kadar Clinic

Other

Registry information

Official study title

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

Important dates

Study start
2015
Primary completion
2015
Study completion
2015
First posted
Oct 1, 2015
Registry last updated
Oct 1, 2015

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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