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

April 24, 2014 updated by: Jaime Ruiz-Tovar, MD, PhD, Hospital General Universitario Elche
Percutaneous neurostimulation of dermatome T7 increases Insulin segregation by the apancreas and improves glycemic profile in diabetic patients

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

60

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Spain
    • Alicante
      • Elche, Alicante, Spain, 03203
        • General Hospital Elche

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

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

Exclusion Criteria:

  • Under insulin treatment
  • Endocrinological disorders causing diabetes mellitus

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: Diet
The patients follow only a 1200 Kcal diet
Device: Percutaneous Neurostimulation (PENS) of dermatome T7
The patients undergo PENS of dermatome T7 and follow a 1200 Kcal diet
Other: 1200 Kcal diet
Experimental: Diet +PENS dermatome T7
The patients undergo PENS of dermatome T7 and follow a 1200 Kcal diet
Device: Percutaneous Neurostimulation (PENS) of dermatome T7
The patients undergo PENS of dermatome T7 and follow a 1200 Kcal diet

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Serum glucose levels (mg/dl)
Time Frame: 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.
Baseline and 12 weeks after beginning the therapy

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Homeostasis model assessment (HOMA)
Time Frame: 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
Baseline and 12 weeks after beginning the therapy

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Hospital General Universitario Elche

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

January 1, 2013

Primary Completion (Actual)

April 1, 2014

Study Completion (Actual)

April 1, 2014

Study Registration Dates

First Submitted

April 18, 2014

First Submitted That Met QC Criteria

April 24, 2014

First Posted (Estimate)

April 25, 2014

Study Record Updates

Last Update Posted (Estimate)

April 25, 2014

Last Update Submitted That Met QC Criteria

April 24, 2014

Last Verified

April 1, 2014

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2014-003

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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