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Completed

NCT Number: NCT02122874

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

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

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Key information

Conditions

Diabetes Mellitus Type 2 in Obese Diabetes Mellitus Diabetes Mellitus, Type 2 Endocrine System Diseases Glucose Metabolism Disorders Metabolic Diseases Nutritional and Metabolic Diseases Type 2 Diabetes Mellitus with Features of Insulin Resistance

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

General Hospital Elche

Elche, Alicante, 03203, Spain

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

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

Exclusion criteria

  • Under insulin treatment
  • Endocrinological disorders causing diabetes mellitus

Treatment and study plan

Percutaneous Neurostimulation (PENS) of dermatome T7

Device

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

1200 Kcal diet

Other

Primary outcomes

  1. 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.

Secondary outcomes

  1. 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

Sponsors and collaborators

Lead sponsor

Hospital General Universitario Elche

Other

Registry information

Important dates

Study start
2013
Primary completion
2014
Study completion
2014
First posted
Apr 25, 2014
Registry last updated
Apr 25, 2014

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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