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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| PENS T6 and 1200 Kcal/day diet | Experimental | 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. |
|
| PENST6 + Normocaloric 2000 Kcal/day diet | Active Comparator | 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. |
|
| TENS T11/ T12 + 1200 Kcal/day diet | Placebo Comparator | 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. |
|
| 1200 Kcal/day diet | Active Comparator | Patients follow only a hypocaloric 1200 Kcal/day diet. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| PENS T6 | Procedure | Patients undergo percutaneous electrical stimulation of dermatome T6, weekly, during 12 weeks. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Weight loss | Weight loss will be evaluated after 12 weeks of treatment | After 12 weeks of treatment |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Dolores Castro | Clinica Garcilaso | Study Chair |
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Data might be published in a journal, always preserving patients´ confidentiality.
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| ID | Term |
|---|---|
| D015431 | Weight Loss |
| ID | Term |
|---|---|
| D001836 | Body Weight Changes |
| D001835 | Body Weight |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
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| ID | Term |
|---|---|
| D004032 | Diet |
| ID | Term |
|---|---|
| D009747 | Nutritional Physiological Phenomena |
| D000066888 | Diet, Food, and Nutrition |
| D010829 | Physiological Phenomena |
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| TENS T11/T12 | Procedure | Patients undergo transcutaneous electrical stimulation of dermatomes T11-T12, weekly, during 12 weeks. |
|
| Hypocaloric 1200 Kcal/day diet | Dietary Supplement | Patients follow a Hypocaloric 1200 Kcal/day diet during 12 weeks. |
|
| Normocaloric 2000 Kcal/day diet | Dietary Supplement | Patients follow a Normocaloric 2000 Kcal/day diet during 12 weeks. |
|