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PENS T6 With Ambulatory Self-applied Patch vs Conventional Procedure

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ClinicalTrials.gov Identifier: NCT02564627
Recruitment Status : Completed
First Posted : October 1, 2015
Last Update Posted : October 1, 2015
Sponsor:
Information provided by (Responsible Party):
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.


Condition or disease Intervention/treatment Phase
Weight Loss Procedure: Self-applied patch Procedure: Conventional procedure Dietary Supplement: 1200 Kcal/day diet Phase 3

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.


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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 90 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official 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
Study Start Date : July 2015
Actual Primary Completion Date : September 2015
Actual Study Completion Date : September 2015

Resource links provided by the National Library of Medicine


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.
Procedure: Conventional procedure
PENS of dermatome T6 will be applied by the MD in the Outpatient Clinic.

Dietary Supplement: 1200 Kcal/day diet
A 1200 Kcal/day diet will be prescribed.

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.




Primary Outcome Measures :
  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 Outcome Measures :
  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.



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

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

Exclusion Criteria:

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02564627


Sponsors and Collaborators
Abdel Kadar Clinic
Investigators
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Principal Investigator: Mohammed Abdel Kadar Kadar Clinic

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Abdel Kadar Clinic
ClinicalTrials.gov Identifier: NCT02564627     History of Changes
Other Study ID Numbers: KC15-02
First Posted: October 1, 2015    Key Record Dates
Last Update Posted: October 1, 2015
Last Verified: September 2015

Additional relevant MeSH terms:
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Weight Loss
Body Weight Changes
Body Weight
Signs and Symptoms