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A prospective randomized study, including moderately obese patients will be included. Patients will be randomized in 3 groups:
The effect on appetite and weight loss will be investigated.
A prospective randomized study, including moderately obese (BMI 30-39 Kg/m2) patients will be included. Patients will be randomized in 3 groups:
The effect on appetite and weight loss will be investigated.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Self-applied patch | Experimental | The patients will use a self-applied patch weekly for PENS of dermatome T6. A 1200 Kcal/day diet will be also prescribed. |
|
| Conventional procedure | Active Comparator | The patient will attend weekly the Outpatient Clinic for receiving the PENS of dermatome T6. The procedure will be performed by the Medicine Doctor. A 1200 Kcal/day diet will be also prescribed. |
|
| 1200 Kcal/day diet | Other | A 1200 Kcal/day diet will be also prescribed. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Self-applied patch | Procedure | An ambulatory self-applied patch will be placed weekly by the patients for PENS of dermatome T6. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Appetite will be quantified with a visual analogic scale | Appetite will be quantified weekly during the 12 weeks of treatment. Appetite will be quantified with a visual analogic scale (0= absence of appetite, 10=uncontrollable appetite) | 12 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Weight loss | Appetite will be quantified weekly during the 12 weeks of treatment | 12 weeks |
| Compliance will be evaluated by means of a food diary filled by the patients and evaluated by a nutritionist |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Mohammed Abdel Kadar | Kadar Clinic | Principal Investigator |
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| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 27289457 | Derived | Abdel-Kadar M. Percutaneous Electrical Neurostimulation (PENS) of Dermatome T6 with an Ambulatory Self-applied Patch vs PENS of Dermatome T6 with Conventional Procedure: Effect on Appetite and Weight Loss in Moderately Obese Patients. Obes Surg. 2016 Dec;26(12):2899-2905. doi: 10.1007/s11695-016-2214-0. |
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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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| Conventional procedure | Procedure | PENS of dermatome T6 will be applied by the MD in the Outpatient Clinic. |
|
| 1200 Kcal/day diet | Dietary Supplement | A 1200 Kcal/day diet will be prescribed. |
|
The compliance with the 3 arms of treatment will be investigated. Diet complience will be evaluated by means of a food diary filled by the patients and evaluated by a nutritionist.
| 12 weeks |