Percutaneous Electric Neurostimulation of Dermatome T7 Im... | NCT02122874 | Trialant

Percutaneous Electric Neurostimulation of Dermatome T7 Im... | NCT02122874 | Trialant

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Diet	Active Comparator	The patients follow only a 1200 Kcal diet	Device: Percutaneous Neurostimulation (PENS) of dermatome T7 Other: 1200 Kcal diet
Diet +PENS dermatome T7	Experimental	The patients undergo PENS of dermatome T7 and follow a 1200 Kcal diet	Device: Percutaneous Neurostimulation (PENS) of dermatome T7

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Percutaneous Neurostimulation (PENS) of dermatome T7	Device	The patients undergo PENS of dermatome T7 and follow a 1200 Kcal diet	Diet Diet +PENS dermatome T7

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Serum glucose levels (mg/dl)	Serum glucose levels will be recorded will be recorded at baseline and 12 weeks after beginning the treatment. Measurement units will be mg/dl.	Baseline and 12 weeks after beginning the therapy

Secondary Outcomes

Measure	Description	Time Frame
Homeostasis model assessment (HOMA)	Insulin resistance will be recorded by the Homeostasis model assessment (HOMA). The calculation formula is: Serum Glucose x Serum Insulin / 405	Baseline and 12 weeks after beginning the therapy