Diabetes Mellitus Type 2 in ObesePhase 3NCT02122874
Percutaneous Electric Neurostimulation of Dermatome T7 Improves Glycemic Profile in Obese and Typo 2 Diabetic Patients
A Phase 3 study testing Percutaneous Neurostimulation (PENS) of dermatome T7 and 1200 Kcal diet in people with Diabetes Mellitus Type 2 in Obese and Type 2 Diabetes Mellitus With Features of Insulin Resistance, run by Hospital General Universitario Elche at 1 site in Spain.
Trial summary
Percutaneous neurostimulation of dermatome T7 increases Insulin segregation by the apancreas and improves glycemic profile in diabetic patients Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Diabetes Mellitus Type 2 in Obese, Type 2 Diabetes Mellitus With Features of Insulin Resistance
- What is being tested?
- Percutaneous Neurostimulation (PENS) of dermatome T7 and 1200 Kcal diet
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteSpain
- Study dates
- Jan 2013to Apr 2014
- Phase
- Phase 3
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- BMI>30 Kg/m2
- Type 2 diabetes mellitus
- Treatment with Metformin
Who cannot join
- Under insulin treatment
- Endocrinological disorders causing diabetes mellitus
Trial locations and contacts
1 site in 1 country.
About this study
Percutaneous neurostimulation of dermatome T7 increases Insulin segregation by the apancreas and improves glycemic profile in diabetic patients
- Conditions
- Diabetes Mellitus Type 2 in Obese, Type 2 Diabetes Mellitus With Features of Insulin Resistance
- Being tested
- Percutaneous Neurostimulation (PENS) of dermatome T7, 1200 Kcal diet
- Keywords
- Percutaneous neurostimulation; dermatome T7, type 2 diabetes
- Medical subject headings
- Diabetes Mellitus, Type 2
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Percutaneous Neurostimulation (PENS) of dermatome T7Device
The patients undergo PENS of dermatome T7 and follow a 1200 Kcal diet
1200 Kcal dietOther
| Study group | Role | What they receive |
|---|---|---|
| Diet | Active comparator | The patients follow only a 1200 Kcal diet Receives: Device: Percutaneous Neurostimulation (PENS) of dermatome T7; Other: 1200 Kcal diet |
| Diet +PENS dermatome T7 | Experimental | The patients undergo PENS of dermatome T7 and follow a 1200 Kcal diet Receives: Device: Percutaneous Neurostimulation (PENS) of dermatome T7 |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Baseline and 12 weeks after beginning the therapy
Secondary outcomes (1)
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
Measured: Baseline and 12 weeks after beginning the therapy
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Apr 2014 (estimated)
- Study startJan 2013
- Primary completionApr 2014
- Study completionApr 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Diabetes Mellitus Type 2 in ObeseStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Investigator
- Enrolment
- 60 participants (actual)
Sponsor and investigators
- Lead sponsor
- Hospital General Universitario Elche
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Jaime Ruiz-Tovar, MD, PhD, Hospital General Universitario Elche
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02122874
- Sponsor's protocol ID
- 2014-003
- Status last verified
- Apr 2014
- First submitted
- 18 Apr 2014
- Last updated
- 25 Apr 2014
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 25 Apr 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Percutaneous Electric Neurostimulation of Dermatome T7 Improves Glycemic Profile in Obese and Typo 2 Diabetic Patients
- ClinicalTrials.gov ID
- NCT02122874
- Acronym / sponsor ID
- 2014-003
- Conditions
- Diabetes Mellitus Type 2 in Obese, Type 2 Diabetes Mellitus With Features of Insulin Resistance
- Keywords
- Percutaneous neurostimulation; dermatome T7, type 2 diabetes
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- Hospital General Universitario ElcheUniversity, hospital or other
- Study start
- Jan 2013
- Primary completion
- Apr 2014 (actual)
- Study completion
- Apr 2014 (actual)
- First posted
- 25 Apr 2014 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Percutaneous neurostimulation of dermatome T7 increases Insulin segregation by the apancreas and improves glycemic profile in diabetic patients
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Diet | Active comparator | Device: Percutaneous Neurostimulation (PENS) of dermatome T7, Other: 1200 Kcal dietThe patients follow only a 1200 Kcal diet |
| Diet +PENS dermatome T7 | Experimental | Device: Percutaneous Neurostimulation (PENS) of dermatome T7The patients undergo PENS of dermatome T7 and follow a 1200 Kcal diet |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- BMI>30 Kg/m2
- Type 2 diabetes mellitus
- Treatment with Metformin
Key exclusion criteria (2 listed)
- Under insulin treatment
- Endocrinological disorders causing diabetes mellitus
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Percutaneous Neurostimulation (PENS) of dermatome T7The patients undergo PENS of dermatome T7 and follow a 1200 Kcal diet | Device | Diet, Diet +PENS dermatome T7 |
| 1200 Kcal diet | Other | Diet |
Primary outcome
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.
1 secondary outcome
Homeostasis model assessment (HOMA)
Time frame: Baseline and 12 weeks after beginning the therapy
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Apr 2014.
Related trials for Diabetes Mellitus Type 2 in Obese
Not yet recruitingPhase 3
A Study to Evaluate the Effectiveness and Safety of the Drug AZD6234 for Managing Weight in Adults Who Are Obese or Overweight. These Participants May or May Not Also Have Type 2 Diabetes
Obesity, Overweight
Not yet recruiting
Impact of Endoscopic Sleeve Gastroplasty (ESG) in Obese Adults With Type 2 Diabetes (T2D)
Type 2 Diabetes Mellitus (T2D), Obesity (BMI>30)
Active, not recruitingPhase 3
AMAZE 2: A Research Study Investigating How Well the Medicine NNC0487-0111 Helps People With Excess Body Weight and Type 2 Diabetes Lose Weight
Diabetes Mellitus, Overweight
Not yet recruitingObservational study
Obesity-Related Indices and Albuminuria in Type 2 Diabetes
Obesity and Diabetes Mellitus, Type 2, Albuminuria
Active, not recruiting
Developing a Learning COmmunity to Increase eNgagemeNt and Enrollment in Cardiovascular Clinical Trials (CONNECT)
Cardiovascular Diseases, Hypertension
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Percutaneous Neurostimulation (PENS) of dermatome T7 and 1200 Kcal diet in people with Diabetes Mellitus Type 2 in Obese and Type 2 Diabetes Mellitus With Features of Insulin Resistance, run by Hospital General Universitario Elche at 1 site in Spain.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 25 Apr 2014. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Spain. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Serum glucose levels (mg/dl) (time frame: Baseline and 12 weeks after beginning the therapy). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 25 Apr 2014.