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Weight Loss and Appetite Reduction After Percutaneous Electrical Stimulation Dermatome T6

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

Study Description
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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.

Condition or disease Intervention/treatment Phase
Weight Loss Procedure: PENS T6 Procedure: TENS T11/T12 Dietary Supplement: Hypocaloric 1200 Kcal/day diet Dietary Supplement: Normocaloric 2000 Kcal/day diet Phase 3

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 Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 200 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
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
Study Start Date : July 2015
Actual Primary Completion Date : December 2015
Actual Study Completion Date : December 2015

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Arms and Interventions
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Arm Intervention/treatment
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.
 Procedure: PENS T6
Patients undergo percutaneous electrical stimulation of dermatome T6, weekly, during 12 weeks.

Dietary Supplement: Hypocaloric 1200 Kcal/day diet
Patients follow a Hypocaloric 1200 Kcal/day diet during 12 weeks.
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.
 Procedure: PENS T6
Patients undergo percutaneous electrical stimulation of dermatome T6, weekly, during 12 weeks.

Dietary Supplement: Normocaloric 2000 Kcal/day diet
Patients follow a Normocaloric 2000 Kcal/day diet during 12 weeks.
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.
 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.
Active Comparator: 1200 Kcal/day diet
Patients follow only a hypocaloric 1200 Kcal/day diet.
 Dietary Supplement: Hypocaloric 1200 Kcal/day diet
Patients follow a Hypocaloric 1200 Kcal/day diet during 12 weeks.


Outcome Measures
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Primary Outcome Measures :
  1. Weight loss [ Time Frame: After 12 weeks of treatment ]
    Weight loss will be evaluated after 12 weeks of treatment


Eligibility Criteria
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Ages Eligible for Study:   Child, Adult, Older Adult
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.
Contacts and Locations
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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): NCT02810925


Sponsors and Collaborators
Hospital General Universitario Elche
Investigators
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Study Chair: Dolores Castro Clinica Garcilaso
More Information
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Responsible Party: Jaime Ruiz-Tovar, MD, PhD, Head of Neurostimulation Unit. Garcilaso Clinic, Hospital General Universitario Elche
ClinicalTrials.gov Identifier: NCT02810925    
Other Study ID Numbers: ClinGarci 16-2
First Posted: June 23, 2016    Key Record Dates
Last Update Posted: June 23, 2016
Last Verified: June 2016
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Plan Description: Data might be published in a journal, always preserving patients´ confidentiality.
Additional relevant MeSH terms:
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Body Weight
Weight Loss
Body Weight Changes