Back to resultsPercutaneous Electric Neurostimulation of Dermatome T7 Improves Glycemic Profile in Obese and Typo 2 Diabetic Patients
Primary Purpose
Diabetes Mellitus Type 2 in Obese, Type 2 Diabetes Mellitus With Features of Insulin Resistance
Status
Completed
Phase
Phase 3
Locations
Spain
Study Type
Interventional
Intervention
Percutaneous Neurostimulation (PENS) of dermatome T7
1200 Kcal diet
Sponsored by
About this trial
This is an interventional treatment trial for Diabetes Mellitus Type 2 in Obese focused on measuring Percutaneous neurostimulation; dermatome T7, type 2 diabetes
Eligibility Criteria
Inclusion Criteria:
- BMI>30 Kg/m2
- Type 2 diabetes mellitus
- Treatment with Metformin
Exclusion Criteria:
- Under insulin treatment
- Endocrinological disorders causing diabetes mellitus
Sites / Locations
- General Hospital Elche
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Experimental
Arm Label
Diet
Diet +PENS dermatome T7
Arm Description
The patients follow only a 1200 Kcal diet
The patients undergo PENS of dermatome T7 and follow a 1200 Kcal diet
Outcomes
Primary Outcome Measures
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.
Secondary Outcome Measures
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
Full Information
NCT ID
NCT02122874
First Posted
April 18, 2014
Last Updated
April 24, 2014
Sponsor
Hospital General Universitario Elche
1. Study Identification
Unique Protocol Identification Number
NCT02122874
Brief Title
Percutaneous Electric Neurostimulation of Dermatome T7 Improves Glycemic Profile in Obese and Typo 2 Diabetic Patients
Study Type
Interventional
2. Study Status
Record Verification Date
April 2014
Overall Recruitment Status
Completed
Study Start Date
January 2013 (undefined)
Primary Completion Date
April 2014 (Actual)
Study Completion Date
April 2014 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Hospital General Universitario Elche
4. Oversight
5. Study Description
Brief Summary
Percutaneous neurostimulation of dermatome T7 increases Insulin segregation by the apancreas and improves glycemic profile in diabetic patients
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Diabetes Mellitus Type 2 in Obese, Type 2 Diabetes Mellitus With Features of Insulin Resistance
Keywords
Percutaneous neurostimulation; dermatome T7, type 2 diabetes
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
Investigator
Allocation
Randomized
Enrollment
60 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Diet
Arm Type
Active Comparator
Arm Description
The patients follow only a 1200 Kcal diet
Arm Title
Diet +PENS dermatome T7
Arm Type
Experimental
Arm Description
The patients undergo PENS of dermatome T7 and follow a 1200 Kcal diet
Intervention Type
Device
Intervention Name(s)
Percutaneous Neurostimulation (PENS) of dermatome T7
Intervention Description
The patients undergo PENS of dermatome T7 and follow a 1200 Kcal diet
Intervention Type
Other
Intervention Name(s)
1200 Kcal diet
Primary Outcome Measure Information:
Title
Serum glucose levels (mg/dl)
Description
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 Outcome Measure Information:
Title
Homeostasis model assessment (HOMA)
Description
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
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
BMI>30 Kg/m2
Type 2 diabetes mellitus
Treatment with Metformin
Exclusion Criteria:
Under insulin treatment
Endocrinological disorders causing diabetes mellitus
Facility Information:
Facility Name
General Hospital Elche
City
Elche
State/Province
Alicante
ZIP/Postal Code
03203
Country
Spain
12. IPD Sharing Statement
Learn more about this trial
Percutaneous Electric Neurostimulation of Dermatome T7 Improves Glycemic Profile in Obese and Typo 2 Diabetic Patients
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