NCT02122874

Brief Summary

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

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
60

participants targeted

Target at below P25 for phase_3

Timeline
Completed

Started Jan 2013

Shorter than P25 for phase_3

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2013

Completed
1.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 1, 2014

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

April 1, 2014

Completed
17 days until next milestone

First Submitted

Initial submission to the registry

April 18, 2014

Completed
7 days until next milestone

First Posted

Study publicly available on registry

April 25, 2014

Completed
Last Updated

April 25, 2014

Status Verified

April 1, 2014

Enrollment Period

1.2 years

First QC Date

April 18, 2014

Last Update Submit

April 24, 2014

Conditions

Diabetes Mellitus Type 2 in ObeseType 2 Diabetes Mellitus With Features of Insulin Resistance

Keywords

Percutaneous neurostimulation; dermatome T7, type 2 diabetes

Outcome Measures

Primary Outcomes (1)

  • 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.

    Baseline and 12 weeks after beginning the therapy

Secondary Outcomes (1)

  • Homeostasis model assessment (HOMA)

    Baseline and 12 weeks after beginning the therapy

Study Arms (2)

Diet

ACTIVE COMPARATOR

The patients follow only a 1200 Kcal diet

Device: Percutaneous Neurostimulation (PENS) of dermatome T7Other: 1200 Kcal diet

Diet +PENS dermatome T7

EXPERIMENTAL

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

Device: Percutaneous Neurostimulation (PENS) of dermatome T7

Interventions

Percutaneous Neurostimulation (PENS) of dermatome T7DEVICE

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

DietDiet +PENS dermatome T7
1200 Kcal dietOTHER
Diet

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

  • Under insulin treatment
  • Endocrinological disorders causing diabetes mellitus

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

General Hospital Elche

Elche, Alicante, 03203, Spain

Location

MeSH Terms

Conditions

Diabetes Mellitus, Type 2

Interventions

Diet

Condition Hierarchy (Ancestors)

Diabetes MellitusGlucose Metabolism DisordersMetabolic DiseasesNutritional and Metabolic DiseasesEndocrine System Diseases

Intervention Hierarchy (Ancestors)

Nutritional Physiological PhenomenaDiet, Food, and NutritionPhysiological Phenomena

Study Design

Study Type
interventional
Phase
phase 3
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
INVESTIGATOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
MD, PhD

Study Record Dates

First Submitted

April 18, 2014

First Posted

April 25, 2014

Study Start

January 1, 2013

Primary Completion

April 1, 2014

Study Completion

April 1, 2014

Last Updated

April 25, 2014

Record last verified: 2014-04

Locations

ES(1)