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Weight Loss and Appetite Reduction After Percutaneous Electrical Stimulation Dermatome T6

Primary Purpose

Weight Loss

Status
Completed
Phase
Phase 3
Locations
Study Type
Interventional
Intervention
PENS T6
TENS T11/T12
Hypocaloric 1200 Kcal/day diet
Normocaloric 2000 Kcal/day diet
Sponsored by
Hospital General Universitario Elche
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Weight Loss

Eligibility Criteria

undefined - undefined (Child, Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm 3

    Arm 4

    Arm Type

    Experimental

    Active Comparator

    Placebo Comparator

    Active Comparator

    Arm Label

    PENS T6 and 1200 Kcal/day diet

    PENST6 + Normocaloric 2000 Kcal/day diet

    TENS T11/ T12 + 1200 Kcal/day diet

    1200 Kcal/day diet

    Arm Description

    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.

    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.

    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.

    Patients follow only a hypocaloric 1200 Kcal/day diet.

    Outcomes

    Primary Outcome Measures

    Weight loss
    Weight loss will be evaluated after 12 weeks of treatment

    Secondary Outcome Measures

    Full Information

    First Posted
    June 21, 2016
    Last Updated
    June 21, 2016
    Sponsor
    Hospital General Universitario Elche
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    1. Study Identification

    Unique Protocol Identification Number
    NCT02810925
    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
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    June 2016
    Overall Recruitment Status
    Completed
    Study Start Date
    July 2015 (undefined)
    Primary Completion Date
    December 2015 (Actual)
    Study Completion Date
    December 2015 (Actual)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Principal Investigator
    Name of the Sponsor
    Hospital General Universitario Elche

    4. Oversight

    Data Monitoring Committee
    Yes

    5. Study Description

    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.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Weight Loss

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Phase 3
    Interventional Study Model
    Parallel Assignment
    Masking
    None (Open Label)
    Allocation
    Randomized
    Enrollment
    200 (Actual)

    8. Arms, Groups, and Interventions

    Arm Title
    PENS T6 and 1200 Kcal/day diet
    Arm Type
    Experimental
    Arm Description
    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.
    Arm Title
    PENST6 + Normocaloric 2000 Kcal/day diet
    Arm Type
    Active Comparator
    Arm Description
    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.
    Arm Title
    TENS T11/ T12 + 1200 Kcal/day diet
    Arm Type
    Placebo Comparator
    Arm Description
    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.
    Arm Title
    1200 Kcal/day diet
    Arm Type
    Active Comparator
    Arm Description
    Patients follow only a hypocaloric 1200 Kcal/day diet.
    Intervention Type
    Procedure
    Intervention Name(s)
    PENS T6
    Intervention Description
    Patients undergo percutaneous electrical stimulation of dermatome T6, weekly, during 12 weeks.
    Intervention Type
    Procedure
    Intervention Name(s)
    TENS T11/T12
    Intervention Description
    Patients undergo transcutaneous electrical stimulation of dermatomes T11-T12, weekly, during 12 weeks.
    Intervention Type
    Dietary Supplement
    Intervention Name(s)
    Hypocaloric 1200 Kcal/day diet
    Intervention Description
    Patients follow a Hypocaloric 1200 Kcal/day diet during 12 weeks.
    Intervention Type
    Dietary Supplement
    Intervention Name(s)
    Normocaloric 2000 Kcal/day diet
    Intervention Description
    Patients follow a Normocaloric 2000 Kcal/day diet during 12 weeks.
    Primary Outcome Measure Information:
    Title
    Weight loss
    Description
    Weight loss will be evaluated after 12 weeks of treatment
    Time Frame
    After 12 weeks of treatment

    10. Eligibility

    Sex
    All
    Accepts Healthy Volunteers
    No
    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.
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    Dolores Castro
    Organizational Affiliation
    Clinica Garcilaso
    Official's Role
    Study Chair

    12. IPD Sharing Statement

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

    Learn more about this trial

    Weight Loss and Appetite Reduction After Percutaneous Electrical Stimulation Dermatome T6

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