Weight Loss and Appetite Reduction After Percutaneous Electrical Stimulation Dermatome T6

Weight Loss Clinical Trial

Official title:

Weight Loss and Appetite Reduction and Their Correlation With Plasmatic Ghrelin Levels After Percutaneous Electrical Stimulation Dermatome T6 Associated With a Hypocaloric Diet

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02810925
• Other study ID #: ClinGarci 16-2
• Status: Completed
• Phase: Phase 3
• First received: June 21, 2016
• Last updated: June 21, 2016
• Start date: July 2015
• Est. completion date: December 2015

Study information

• Verified date: June 2016
• Source: Hospital General Universitario Elche
• Contact: n/a
• Is FDA regulated: No
• Health authority: Spain: Comité Ético de Investigación Clínica
• Study type: Interventional

Clinical Trial Summary

The patients are randomized into 4 groups : Patients undergoing PENS of dermatome T6 in and a 1200 Kcal diet (Group 1), Patients undergoing PENS T6 and a 2000 Kcal/day, Patients undergoing transcutaneous electrical neurostimulation (TENS) of Dermatomes T11-T12 and following a 1200 Kcal diet and those patients following only a 1200 Kcal diet (Group 4). Weight loss, appetite and ghrelin levels at baseline and after treatment are investigated.

Description:

The patients were randomized into 4 groups using an Internet randomization module: Patients undergoing PENS of dermatome T6 in conjunction with the implementation of a 1200 Kcal diet (Group 1), Patients undergoing PENS T6 and following a normocaloric diet (2000 Kcal/day) (Group 2), Patients undergoing transcutaneous electrical neurostimulation (TENS) of dermatomes in right iliac fossa (Dermatomes T11-T12) and following a hypocaloric diet (1200 Kcal/day) (Group 3) and those patients following only a 1200 Kcal diet (Group 4).

Weight loss, appetite and ghrelin levels, at baseline and after treatment, are investigated.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 200
• Est. completion date: December 2015
• Est. primary completion date: December 2015
• Accepts healthy volunteers: No
• Gender: Both
• Age group: N/A and older

Eligibility

Inclusion Criteria:

• Patients with obesity (BMI>30 Kg/m2) or overweight (BMI 25-30 Kg/m2)

Exclusion Criteria:

• Untreated endocrine disease causing obesity

• Serious psychiatric illness.

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:
• PENS T6
Patients undergo percutaneous electrical stimulation of dermatome T6, weekly, during 12 weeks.
• TENS T11/T12
Patients undergo transcutaneous electrical stimulation of dermatomes T11-T12, weekly, during 12 weeks.

Dietary Supplement:
• Hypocaloric 1200 Kcal/day diet
Patients follow a Hypocaloric 1200 Kcal/day diet during 12 weeks.
• Normocaloric 2000 Kcal/day diet
Patients follow a Normocaloric 2000 Kcal/day diet during 12 weeks.

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Hospital General Universitario Elche

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Weight loss	Weight loss will be evaluated after 12 weeks of treatment	After 12 weeks of treatment	No