Weight LossPhase 3NCT02810925
Weight Loss and Appetite Reduction After Percutaneous Electrical Stimulation Dermatome T6
A Phase 3 study testing PENS T6, TENS T11/T12 and Hypocaloric 1200 Kcal/day diet in people with Weight Loss, run by Hospital General Universitario Elche.
Trial summary
The patients are randomized into 4 groups : Patients undergoing PENS of dermatome T6 in and a 1200 Kcal diet (Group 1), Patients undergoing PENS T6 and a 2000 Kcal/day, Patients undergoing transcutaneous electrical neurostimulation (TENS) of Dermatomes T11-T12 and following a 1200 Kcal diet and those patients… Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Weight Loss
- What is being tested?
- PENS T6, TENS T11/T12 and Hypocaloric 1200 Kcal/day diet
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 200 participants
- Where
- No sites listed yet
- Study dates
- Jul 2015to Dec 2015
- 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 Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Patients with obesity (BMI>30 Kg/m2) or overweight (BMI 25-30 Kg/m2)
Who cannot join
- Untreated endocrine disease causing obesity
- Serious psychiatric illness.
About this study
Official title: Weight Loss and Appetite Reduction and Their Correlation With Plasmatic Ghrelin Levels After Percutaneous Electrical Stimulation Dermatome T6 Associated With a Hypocaloric Diet
The patients are randomized into 4 groups : Patients undergoing PENS of dermatome T6 in and a 1200 Kcal diet (Group 1), Patients undergoing PENS T6 and a 2000 Kcal/day, Patients undergoing transcutaneous electrical neurostimulation (TENS) of Dermatomes T11-T12 and following a 1200 Kcal diet and those patients following only a 1200 Kcal diet (Group 4). Weight loss, appetite and ghrelin levels at baseline and after treatment are investigated.
Read the detailed description
The patients were randomized into 4 groups using an Internet randomization module: Patients undergoing PENS of dermatome T6 in conjunction with the implementation of a 1200 Kcal diet (Group 1), Patients undergoing PENS T6 and following a normocaloric diet (2000 Kcal/day) (Group 2), Patients undergoing transcutaneous electrical neurostimulation (TENS) of dermatomes in right iliac fossa (Dermatomes T11-T12) and following a hypocaloric diet (1200 Kcal/day) (Group 3) and those patients following only a 1200 Kcal diet (Group 4).
Weight loss, appetite and ghrelin levels, at baseline and after treatment, are investigated.
- Conditions
- Weight Loss
- Being tested
- PENS T6, TENS T11/T12, Hypocaloric 1200 Kcal/day diet, Normocaloric 2000 Kcal/day diet
- Medical subject headings
- Weight Loss
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PENS T6Procedure or surgery
Patients undergo percutaneous electrical stimulation of dermatome T6, weekly, during 12 weeks.
TENS T11/T12Procedure or surgery
Patients undergo transcutaneous electrical stimulation of dermatomes T11-T12, weekly, during 12 weeks.
Hypocaloric 1200 Kcal/day dietDietary supplement
Patients follow a Hypocaloric 1200 Kcal/day diet during 12 weeks.
Normocaloric 2000 Kcal/day dietDietary supplement
Patients follow a Normocaloric 2000 Kcal/day diet during 12 weeks.
| Study group | Role | What they receive |
|---|---|---|
| PENS T6 and 1200 Kcal/day diet | Experimental | Patients undergo 12 sessions of percutaneous electrical stimulation of dermatome T6 (PENS T6), weekly, during 12 weeks. During this period they follow a hypocaloric 1200 Kcal/day diet. Receives: Procedure: PENS T6; Dietary Supplement: Hypocaloric 1200 Kcal/day diet |
| PENST6 + Normocaloric 2000 Kcal/day diet | Active comparator | Patients undergo 12 sessions of percutaneous electrical stimulation of dermatome T6 (PENS T6), weekly, during 12 weeks. During this period they follow a normocaloric 2000 Kcal/day diet. Receives: Procedure: PENS T6; Dietary Supplement: Normocaloric 2000 Kcal/day diet |
| TENS T11/ T12 + 1200 Kcal/day diet | Placebo comparator | Patients undergo 12 sessions of transcutaneous electrical stimulation of dermatomes T11-T12 , weekly, during 12 weeks. During this period they follow a hypocaloric 1200 Kcal/day diet. Receives: Procedure: TENS T11/T12; Dietary Supplement: Hypocaloric 1200 Kcal/day diet |
| 1200 Kcal/day diet | Active comparator | Patients follow only a hypocaloric 1200 Kcal/day diet. Receives: Dietary Supplement: Hypocaloric 1200 Kcal/day diet |
What is being measured
The primary outcome is the main question the study is designed to answer.
Weight loss
Weight loss will be evaluated after 12 weeks of treatment
Measured: After 12 weeks of treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Jun 2016 (estimated)
- Study startJul 2015
- Primary completionDec 2015
- Study completionDec 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Weight LossStudies 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
- None (open label)
- Enrolment
- 200 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
- Investigators
- Dolores Castro, Study chair, Clinica Garcilaso
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02810925
- Sponsor's protocol ID
- ClinGarci 16-2
- Status last verified
- Jun 2016
- First submitted
- 21 Jun 2016
- Last updated
- 23 Jun 2016
- Results posted
- No
- Data monitoring committee
- Yes
- Individual data sharing
- Yes: Data might be published in a journal, always preserving patients´ confidentiality.
Study at a glance
From the registry record, last updated by the sponsor on 23 Jun 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Weight Loss and Appetite Reduction and Their Correlation With Plasmatic Ghrelin Levels After Percutaneous Electrical Stimulation Dermatome T6 Associated With a Hypocaloric Diet
- ClinicalTrials.gov ID
- NCT02810925
- Acronym / sponsor ID
- ClinGarci 16-2
- Conditions
- Weight Loss
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 200 participants (actual)
- Lead sponsor
- Hospital General Universitario ElcheUniversity, hospital or other
- Study start
- Jul 2015
- Primary completion
- Dec 2015 (actual)
- Study completion
- Dec 2015 (actual)
- First posted
- 23 Jun 2016 (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.
The patients are randomized into 4 groups : Patients undergoing PENS of dermatome T6 in and a 1200 Kcal diet (Group 1), Patients undergoing PENS T6 and a 2000 Kcal/day, Patients undergoing transcutaneous electrical neurostimulation (TENS) of Dermatomes T11-T12 and following a 1200 Kcal diet and those patients following only a 1200 Kcal diet (Group 4). Weight loss, appetite and ghrelin levels at baseline and after treatment are investigated.
Detailed description
The patients were randomized into 4 groups using an Internet randomization module: Patients undergoing PENS of dermatome T6 in conjunction with the implementation of a 1200 Kcal diet (Group 1), Patients undergoing PENS T6 and following a normocaloric diet (2000 Kcal/day) (Group 2), Patients undergoing transcutaneous electrical neurostimulation (TENS) of dermatomes in right iliac fossa (Dermatomes T11-T12) and following a hypocaloric diet (1200 Kcal/day) (Group 3) and those patients following only a 1200 Kcal diet (Group 4).
Weight loss, appetite and ghrelin levels, at baseline and after treatment, are investigated.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| PENS T6 and 1200 Kcal/day diet | Experimental | Procedure: PENS T6, Dietary Supplement: Hypocaloric 1200 Kcal/day dietPatients undergo 12 sessions of percutaneous electrical stimulation of dermatome T6 (PENS T6), weekly, during 12 weeks. During this period they follow a hypocaloric 1200 Kcal/day diet. |
| PENST6 + Normocaloric 2000 Kcal/day diet | Active comparator | Procedure: PENS T6, Dietary Supplement: Normocaloric 2000 Kcal/day dietPatients undergo 12 sessions of percutaneous electrical stimulation of dermatome T6 (PENS T6), weekly, during 12 weeks. During this period they follow a normocaloric 2000 Kcal/day diet. |
| TENS T11/ T12 + 1200 Kcal/day diet | Placebo comparator | Procedure: TENS T11/T12, Dietary Supplement: Hypocaloric 1200 Kcal/day dietPatients undergo 12 sessions of transcutaneous electrical stimulation of dermatomes T11-T12 , weekly, during 12 weeks. During this period they follow a hypocaloric 1200 Kcal/day diet. |
| 1200 Kcal/day diet | Active comparator | Dietary Supplement: Hypocaloric 1200 Kcal/day dietPatients follow only a hypocaloric 1200 Kcal/day diet. |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (1 listed)
- Patients with obesity (BMI>30 Kg/m2) or overweight (BMI 25-30 Kg/m2)
Key exclusion criteria (2 listed)
- Untreated endocrine disease causing obesity
- Serious psychiatric illness.
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 |
|---|---|---|
| PENS T6Patients undergo percutaneous electrical stimulation of dermatome T6, weekly, during 12 weeks. | Procedure or surgery | PENS T6 and 1200 Kcal/day diet, PENST6 + Normocaloric 2000 Kcal/day diet |
| TENS T11/T12Patients undergo transcutaneous electrical stimulation of dermatomes T11-T12, weekly, during 12 weeks. | Procedure or surgery | TENS T11/ T12 + 1200 Kcal/day diet |
| Hypocaloric 1200 Kcal/day dietPatients follow a Hypocaloric 1200 Kcal/day diet during 12 weeks. | Dietary supplement | 1200 Kcal/day diet, PENS T6 and 1200 Kcal/day diet, TENS T11/ T12 + 1200 Kcal/day diet |
| Normocaloric 2000 Kcal/day dietPatients follow a Normocaloric 2000 Kcal/day diet during 12 weeks. | Dietary supplement | PENST6 + Normocaloric 2000 Kcal/day diet |
Primary outcome
Weight loss
Time frame: After 12 weeks of treatment
Weight loss will be evaluated after 12 weeks of treatment
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 23 Jun 2016.
- Individual participant dataSharing planned: Yes. Data might be published in a journal, always preserving patients´ confidentiality.
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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.
Dolores Castro study chair
Clinica Garcilaso
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing PENS T6, TENS T11/T12 and Hypocaloric 1200 Kcal/day diet in people with Weight Loss, run by Hospital General Universitario Elche.
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 1 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 23 Jun 2016. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. 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?
Weight loss (time frame: After 12 weeks of treatment). 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 23 Jun 2016.