Weight Loss and Appetite Reduction After Percutaneous Electrical Stimulation Dermatome T6

NCT02810925 | Completed Phase 3 DMC

• 1 other identifier: ClinGarci 16-2
• Study Type: interventional
• Target: 200
• Locations: 0 countries
• Sites: N/A

Brief 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.

Conditions

Weight Loss

Outcome Measures

Primary Outcomes (1)

• Weight loss

  Weight loss will be evaluated after 12 weeks of treatment

  After 12 weeks of treatment

Study Arms (4)

PENS T6 and 1200 Kcal/day diet

EXPERIMENTAL

Patients undergo 12 sessions of percutaneous electrical stimulation of dermatome T6 (PENS T6), weekly, during 12 weeks. During this period they follow a hypocaloric 1200 Kcal/day diet.

Procedure: PENS T6; Dietary Supplement: Hypocaloric 1200 Kcal/day diet

PENST6 + Normocaloric 2000 Kcal/day diet

ACTIVE COMPARATOR

Patients undergo 12 sessions of percutaneous electrical stimulation of dermatome T6 (PENS T6), weekly, during 12 weeks. During this period they follow a normocaloric 2000 Kcal/day diet.

Procedure: PENS T6; Dietary Supplement: Normocaloric 2000 Kcal/day diet

TENS T11/ T12 + 1200 Kcal/day diet

PLACEBO COMPARATOR

Patients undergo 12 sessions of transcutaneous electrical stimulation of dermatomes T11-T12 , weekly, during 12 weeks. During this period they follow a hypocaloric 1200 Kcal/day diet.

Procedure: TENS T11/T12; Dietary Supplement: Hypocaloric 1200 Kcal/day diet

1200 Kcal/day diet

ACTIVE COMPARATOR

Patients follow only a hypocaloric 1200 Kcal/day diet.

Dietary Supplement: Hypocaloric 1200 Kcal/day diet

Interventions

PENS T6 PROCEDURE

Patients undergo percutaneous electrical stimulation of dermatome T6, weekly, during 12 weeks.

PENS T6 and 1200 Kcal/day diet; PENST6 + Normocaloric 2000 Kcal/day diet

TENS T11/T12 PROCEDURE

Patients undergo transcutaneous electrical stimulation of dermatomes T11-T12, weekly, during 12 weeks.

TENS T11/ T12 + 1200 Kcal/day diet

Hypocaloric 1200 Kcal/day diet DIETARY_SUPPLEMENT

Patients follow a Hypocaloric 1200 Kcal/day diet during 12 weeks.

1200 Kcal/day diet; PENS T6 and 1200 Kcal/day diet; TENS T11/ T12 + 1200 Kcal/day diet

Normocaloric 2000 Kcal/day diet DIETARY_SUPPLEMENT

Patients follow a Normocaloric 2000 Kcal/day diet during 12 weeks.

PENST6 + Normocaloric 2000 Kcal/day diet

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• Untreated endocrine disease causing obesity
• Serious psychiatric illness.

Sponsors & Collaborators

• Hospital General Universitario Elche: lead

MeSH Terms

Conditions

Weight Loss

Interventions

Diet

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Nutritional Physiological Phenomena; Diet, Food, and Nutrition; Physiological Phenomena

Study Officials

• Dolores Castro

  Clinica Garcilaso

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Head of Neurostimulation Unit. Garcilaso Clinic

Study Record Dates

• First Submitted: June 21, 2016
• First Posted: June 23, 2016
• Study Start: July 1, 2015
• Primary Completion: December 1, 2015
• Study Completion: December 1, 2015
• Last Updated: June 23, 2016

Record last verified: 2016-06

Data Sharing

• IPD Sharing: Will share