PENS T6 With Ambulatory Self-applied Patch vs Conventional Procedure

Weight Loss Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02564627
• Other study ID #: KC15-02
• Status: Completed
• Phase: Phase 3
• First received: September 25, 2015
• Last updated: September 30, 2015
• Start date: July 2015
• Est. completion date: September 2015

Study information

• Verified date: September 2015
• Source: Abdel Kadar Clinic
• Contact: n/a
• Is FDA regulated: No
• Health authority: United Arab Emirates: Ministry of Health
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 90
• Est. completion date: September 2015
• Est. primary completion date: September 2015
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

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

Exclusion Criteria:

• Endocrinological diseases causing obesity

• Heart pacemaker

• Previous bariatric procedure

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Weight Loss

Intervention

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

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Abdel Kadar Clinic

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	No
Secondary	Weight loss	Appetite will be quantified weekly during the 12 weeks of treatment	12 weeks	Yes
Secondary	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	No