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

Status

Completed

Phases

Phase 3

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT02122874

Enrollment

Registered

2014-04-25

Start date

2013-01-31

Completion date

2014-04-30

Last updated

2014-04-25

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

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

Keywords

Percutaneous neurostimulation; dermatome T7, type 2 diabetes

Brief summary

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

Interventions

DEVICEPercutaneous Neurostimulation (PENS) of dermatome T7

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

OTHER1200 Kcal diet

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

SINGLE (Investigator)

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

Inclusion criteria

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

Exclusion criteria

* Under insulin treatment * Endocrinological disorders causing diabetes mellitus

Design outcomes

Primary

Measure	Time frame	Description
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

Measure	Time frame	Description
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

Countries

Spain

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026