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

Phase 3

Completed

• Conditions: Diabetes Mellitus Type 2 in Obese; Type 2 Diabetes Mellitus With Features of Insulin Resistance
• Interventions: Device: Percutaneous Neurostimulation (PENS) of dermatome T7; Other: 1200 Kcal diet

• Registration Number: NCT02122874
• Lead Sponsor: Hospital General Universitario Elche

Brief Summary

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

Detailed Description

Not available

Study Timeline

• Study Start: 2013-01
• Status Verified: 2014-04
• Primary Completion: 2014-04
• Study Completion: 2014-04
• Study First Submitted: 2014-04-18
• Study First Submitted QC: 2014-04-24
• Last Update Submitted: 2014-04-24
• Study First Posted: 2014-04-25
• Last Update Posted: 2014-04-25

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 60

Inclusion Criteria

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

Exclusion Criteria

• Under insulin treatment
• Endocrinological disorders causing diabetes mellitus

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Diet +PENS dermatome T7	Percutaneous Neurostimulation (PENS) of dermatome T7	The patients undergo PENS of dermatome T7 and follow a 1200 Kcal diet
Diet	Percutaneous Neurostimulation (PENS) of dermatome T7	The patients follow only a 1200 Kcal diet
Diet	1200 Kcal diet	The patients follow only a 1200 Kcal diet

Primary Outcome Measures

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

Secondary Outcome Measures

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

Trial Locations

Locations (1)

General Hospital Elche; 🇪🇸 Elche, Alicante, Spain