Weight Loss and Appetite Reduction After Percutaneous Electrical Stimulation Dermatome T6

• ClinicalTrials.gov Identifier: NCT02810925
• Recruitment Status: Completed
• First Posted: June 23, 2016
• Last Update Posted: June 23, 2016
• Sponsor: Hospital General Universitario Elche
• Information provided by (Responsible Party): Jaime Ruiz-Tovar, MD, PhD, Hospital General Universitario Elche

Tracking Information

• First Submitted Date: June 21, 2016
• First Posted Date: June 23, 2016
• Last Update Posted Date: June 23, 2016
• Study Start Date: July 2015
• Actual Primary Completion Date: December 2015 (Final data collection date for primary outcome measure)

Current Primary Outcome Measures (submitted: June 21, 2016)

Weight loss [ Time Frame: After 12 weeks of treatment ]

Weight loss will be evaluated after 12 weeks of treatment

• Original Primary Outcome Measures: Same as current
• Change History: No Changes Posted
• Current Secondary Outcome Measures: Not Provided
• Original Secondary Outcome Measures: Not Provided
• Current Other Pre-specified Outcome Measures: Not Provided
• Original Other Pre-specified Outcome Measures: Not Provided

Descriptive Information

• Brief Title: Weight Loss and Appetite Reduction After Percutaneous Electrical Stimulation Dermatome T6
• 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
• 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.

Detailed 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.

• Study Type: Interventional
• Study Phase: Phase 3
• Study Design: Allocation: Randomized; Intervention Model: Parallel Assignment; Masking: None (Open Label); Primary Purpose: Treatment
• Condition: Weight Loss

Intervention

• Procedure: PENS T6
  Patients undergo percutaneous electrical stimulation of dermatome T6, weekly, during 12 weeks.
• Procedure: 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.
• Dietary Supplement: Normocaloric 2000 Kcal/day diet
  Patients follow a Normocaloric 2000 Kcal/day diet during 12 weeks.

Study Arms

• Experimental: PENS T6 and 1200 Kcal/day diet
  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.
  Interventions:

  • Procedure: PENS T6
  • Dietary Supplement: Hypocaloric 1200 Kcal/day diet
• Active Comparator: PENST6 + Normocaloric 2000 Kcal/day diet
  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.
  Interventions:

  • Procedure: PENS T6
  • Dietary Supplement: Normocaloric 2000 Kcal/day diet
• Placebo Comparator: TENS T11/ T12 + 1200 Kcal/day diet
  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.
  Interventions:

  • Procedure: TENS T11/T12
  • Dietary Supplement: Hypocaloric 1200 Kcal/day diet
• Active Comparator: 1200 Kcal/day diet
  Patients follow only a hypocaloric 1200 Kcal/day diet.
  Intervention: Dietary Supplement: Hypocaloric 1200 Kcal/day diet

• Publications *: Not Provided

Recruitment Information

• Recruitment Status: Completed
• Actual Enrollment (submitted: June 21, 2016): 200
• Original Actual Enrollment: Same as current
• Actual Study Completion Date: December 2015
• Actual Primary Completion Date: December 2015 (Final data collection date for primary outcome measure)

Eligibility Criteria

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.

Sex/Gender

• Sexes Eligible for Study: All

• Ages: Child, Adult, Older Adult
• Accepts Healthy Volunteers: No
• Contacts: Contact information is only displayed when the study is recruiting subjects
• Listed Location Countries: Not Provided

Administrative Information

• NCT Number: NCT02810925
• Other Study ID Numbers: ClinGarci 16-2
• Has Data Monitoring Committee: Yes
• U.S. FDA-regulated Product: Not Provided

IPD Sharing Statement

• Plan to Share IPD: Yes
• Plan Description: Data might be published in a journal, always preserving patients´ confidentiality.

• Responsible Party: Jaime Ruiz-Tovar, MD, PhD, Hospital General Universitario Elche
• Study Sponsor: Hospital General Universitario Elche
• Collaborators: Not Provided

Investigators

• Study Chair: Dolores Castro; Clinica Garcilaso

• PRS Account: Hospital General Universitario Elche
• Verification Date: June 2016