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Weight Loss and Appetite Reduction After Percutaneous Electrical Stimulation Dermatome T6

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
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

Tracking Information
First Submitted Date  ICMJE June 21, 2016
First Posted Date  ICMJE June 23, 2016
Last Update Posted Date June 23, 2016
Study Start Date  ICMJE July 2015
Actual Primary Completion Date December 2015   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (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  ICMJE Same as current
Change History No Changes Posted
Current Secondary Outcome Measures  ICMJE Not Provided
Original Secondary Outcome Measures  ICMJE Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Weight Loss and Appetite Reduction After Percutaneous Electrical Stimulation Dermatome T6
Official Title  ICMJE 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  ICMJE Interventional
Study Phase  ICMJE Phase 3
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Weight Loss
Intervention  ICMJE
  • 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  ICMJE
  • 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

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: June 21, 2016)
200
Original Actual Enrollment  ICMJE Same as current
Actual Study Completion Date  ICMJE December 2015
Actual Primary Completion Date December 2015   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE Child, Adult, Older Adult
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Not Provided
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT02810925
Other Study ID Numbers  ICMJE ClinGarci 16-2
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE
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  ICMJE Hospital General Universitario Elche
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Chair: Dolores Castro Clinica Garcilaso
PRS Account Hospital General Universitario Elche
Verification Date June 2016

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP