Weight Loss and Appetite Reduction After Percutaneous Electrical Stimulation Dermatome T6
NCT ID: NCT02810925
Last Updated: 2016-06-23
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE3
200 participants
INTERVENTIONAL
2015-07-31
2015-12-31
Brief Summary
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Detailed Description
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Weight loss, appetite and ghrelin levels, at baseline and after treatment, are investigated.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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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.
PENS T6
Patients undergo percutaneous electrical stimulation of dermatome T6, weekly, during 12 weeks.
Hypocaloric 1200 Kcal/day diet
Patients follow a Hypocaloric 1200 Kcal/day diet during 12 weeks.
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.
PENS T6
Patients undergo percutaneous electrical stimulation of dermatome T6, weekly, during 12 weeks.
Normocaloric 2000 Kcal/day diet
Patients follow a Normocaloric 2000 Kcal/day diet during 12 weeks.
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.
TENS T11/T12
Patients undergo transcutaneous electrical stimulation of dermatomes T11-T12, weekly, during 12 weeks.
Hypocaloric 1200 Kcal/day diet
Patients follow a Hypocaloric 1200 Kcal/day diet during 12 weeks.
1200 Kcal/day diet
Patients follow only a hypocaloric 1200 Kcal/day diet.
Hypocaloric 1200 Kcal/day diet
Patients follow a Hypocaloric 1200 Kcal/day diet during 12 weeks.
Interventions
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PENS T6
Patients undergo percutaneous electrical stimulation of dermatome T6, weekly, during 12 weeks.
TENS T11/T12
Patients undergo transcutaneous electrical stimulation of dermatomes T11-T12, weekly, during 12 weeks.
Hypocaloric 1200 Kcal/day diet
Patients follow a Hypocaloric 1200 Kcal/day diet during 12 weeks.
Normocaloric 2000 Kcal/day diet
Patients follow a Normocaloric 2000 Kcal/day diet during 12 weeks.
Eligibility Criteria
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Inclusion Criteria
Exclusion Criteria
* Serious psychiatric illness.
ALL
No
Sponsors
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Hospital General Universitario Elche
OTHER
Responsible Party
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Jaime Ruiz-Tovar, MD, PhD
Head of Neurostimulation Unit. Garcilaso Clinic
Principal Investigators
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Dolores Castro
Role: STUDY_CHAIR
Clinica Garcilaso
Other Identifiers
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ClinGarci 16-2
Identifier Type: -
Identifier Source: org_study_id
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