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

Hospital General Universitario Elche60 enrolled

Overview

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

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

SINGLE

Enrollment

Conditions

Diabetes Mellitus Type 2 in Obese Type 2 Diabetes Mellitus With Features of Insulin Resistance

Interventions

Percutaneous Neurostimulation (PENS) of dermatome T7DEVICE

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

1200 Kcal dietOTHER

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

Inclusion Criteria: * BMI\>30 Kg/m2 * Type 2 diabetes mellitus * Treatment with Metformin Exclusion Criteria: * Under insulin treatment * Endocrinological disorders causing diabetes mellitus

Locations (1)

General Hospital Elche

Elche, Alicante, Spain

Outcomes

Primary Outcomes

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.

Time frame: Baseline and 12 weeks after beginning the therapy

Secondary Outcomes

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

Time frame: Baseline and 12 weeks after beginning the therapy

Data from ClinicalTrials.gov

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