Percutaneous Electric Neurostimulation of Dermatome T7 Improves Glycemic Profile in Obese and Typo 2 Diabetic Patients

Hospital General Universitario Elche

Status and phase: Completed; Phase 3

Conditions: Diabetes Mellitus Type 2 in Obese; Type 2 Diabetes Mellitus With Features of Insulin Resistance

Treatments: Other: 1200 Kcal diet; Device: Percutaneous Neurostimulation (PENS) of dermatome T7

Study type: Interventional

Funder types: Other

Identifiers

NCT02122874

2014-003

Details and patient eligibility

About

Percutaneous neurostimulation of dermatome T7 increases Insulin segregation by the apancreas and improves glycemic profile in diabetic patients

Enrollment: 60 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• BMI>30 Kg/m2
• Type 2 diabetes mellitus
• Treatment with Metformin

Exclusion criteria

• Under insulin treatment
• Endocrinological disorders causing diabetes mellitus

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

---

60 participants in 2 patient groups

Diet

Active Comparator group

Description:

The patients follow only a 1200 Kcal diet

Treatment:

Device: Percutaneous Neurostimulation (PENS) of dermatome T7

Other: 1200 Kcal diet

Diet +PENS dermatome T7

Experimental group

Description:

The patients undergo PENS of dermatome T7 and follow a 1200 Kcal diet

Treatment:

Device: Percutaneous Neurostimulation (PENS) of dermatome T7