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

Diabetes Mellitus Type 2 in Obese Clinical Trial

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02122874
• Other study ID #: 2014-003
• Status: Completed
• Phase: Phase 3
• First received: April 18, 2014
• Last updated: April 24, 2014
• Start date: January 2013
• Est. completion date: April 2014

Study information

• Verified date: April 2014
• Source: Hospital General Universitario Elche
• Contact: n/a
• Is FDA regulated: No
• Health authority: Spain: Comité Ético de Investigación Clínica
• Study type: Interventional

Clinical Trial Summary

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 60
• Est. completion date: April 2014
• Est. primary completion date: April 2014
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Single Blind (Investigator), Primary Purpose: Treatment

Related Conditions & MeSH terms

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

Intervention

Device:
• Percutaneous Neurostimulation (PENS) of dermatome T7
The patients undergo PENS of dermatome T7 and follow a 1200 Kcal diet

Other:
• 1200 Kcal diet

Locations

Country	Name	City	State
Spain	General Hospital Elche	Elche	Alicante

Sponsors (1)

Lead Sponsor	Collaborator
Hospital General Universitario Elche

Country where clinical trial is conducted

Spain, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Yes
Secondary	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	Yes