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.
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
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
200
Patients undergo percutaneous electrical stimulation of dermatome T6, weekly, during 12 weeks.
Patients undergo transcutaneous electrical stimulation of dermatomes T11-T12, weekly, during 12 weeks.
Patients follow a Hypocaloric 1200 Kcal/day diet during 12 weeks.
Weight loss
Weight loss will be evaluated after 12 weeks of treatment
Time frame: After 12 weeks of treatment
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Patients follow a Normocaloric 2000 Kcal/day diet during 12 weeks.