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
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Condition or disease | Intervention/treatment | Phase |
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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 |
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 (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 |

Arm | Intervention/treatment |
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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.
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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.
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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.
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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.
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Dietary Supplement: Hypocaloric 1200 Kcal/day diet
Patients follow a Hypocaloric 1200 Kcal/day diet during 12 weeks. |
- Weight loss [ Time Frame: After 12 weeks of treatment ]Weight loss will be evaluated after 12 weeks of treatment

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Ages Eligible for Study: | Child, Adult, Older Adult |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
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.

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
Study Chair: | Dolores Castro | Clinica Garcilaso |
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. |
Body Weight Weight Loss Body Weight Changes |