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

• Sponsor: Hospital General Universitario Elche (Other)
• Overall Status: Completed
• CT.gov ID: NCT02122874
• Collaborator: (none)
• Enrollment: 60
• Location: 1
• Arms: 2
• Duration (Months): 14.9
• Patients Per Site Per Month: 4

Study Details

Study Description

Brief Summary

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

Condition or Disease	Intervention/Treatment	Phase
Diabetes Mellitus Type 2 in Obese; Type 2 Diabetes Mellitus With Features of Insulin Resistance	Device: Percutaneous Neurostimulation (PENS) of dermatome T7; Other: 1200 Kcal diet	Phase 3

Study Design

• Study Type: Interventional
• Actual Enrollment: 60 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Single (Investigator)
• Primary Purpose: Treatment
• Study Start Date: Jan 1, 2013
• Actual Primary Completion Date: Apr 1, 2014
• Actual Study Completion Date: Apr 1, 2014

Arms and Interventions

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

Outcome Measures

Primary Outcome Measures

1. 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

1. 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

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

Inclusion Criteria:

• BMI>30 Kg/m2

• Type 2 diabetes mellitus

• Treatment with Metformin

Exclusion Criteria:

• Under insulin treatment

• Endocrinological disorders causing diabetes mellitus

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	General Hospital Elche	Elche	Alicante	Spain	03203

Sponsors and Collaborators

• Hospital General Universitario Elche

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Jaime Ruiz-Tovar, MD, PhD, MD, PhD, Hospital General Universitario Elche
• ClinicalTrials.gov Identifier: NCT02122874
• Other Study ID Numbers: 2014-003
• First Posted: Apr 25, 2014
• Last Update Posted: Apr 25, 2014
• Last Verified: Apr 1, 2014

• Keywords provided by Jaime Ruiz-Tovar, MD, PhD, MD, PhD, Hospital General Universitario Elche: Percutaneous neurostimulation; dermatome T7, type 2 diabetes
• Additional relevant MeSH terms: Diabetes Mellitus; Diabetes Mellitus, Type 2; Insulin Resistance

Study Results

No Results Posted as of Apr 25, 2014