Diabetes Mellitus, Type 2Phase 3PNITNCT02536820
Psychoneuroimmunology Therapy in Uncontrolled Diabetic Patients: A Quasi-experimental Study
A Phase 3 study testing psychoneuroimmune therapy and Conventional treatment in people with Diabetes Mellitus, Type 2, run by Fundación Salutia.
Trial summary
The Psychoneuroimmunotherapy (PNIT) is the study, modification and implementation of the interactions between the processes of adaptive behavior, neurological, endocrine and immune. Among its premises assuming homeostasis or physiological balance as an integrated process involving the systems above mentioned. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Diabetes Mellitus, Type 2
- What is being tested?
- psychoneuroimmune therapy and Conventional treatment
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 500 participants
- Where
- No sites listed yet
- Study dates
- Sep 2015to Sep 2016
- 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
- Patients who wish to participate with informed consent sign.
- Diagnosed with uncontrolled diabetes mellitus type II (> 7% of HbAc1) at least six months before starting the study
- No change in medication at least three months before starting the study.
- Participants with acceptable electrocardiographic results acceptable at the study start.
Who cannot join
- Pregnant women, or planning to become pregnant during the study period.
- History of severe liver failure.
- Participants requiring elective surgeries or other procedures requiring general anesthesia for the duration of the study.
- Participants who are participating in other clinical trials involving drugs or who have participated in another clinical trial in the last three months.
About this study
The Psychoneuroimmunotherapy (PNIT) is the study, modification and implementation of the interactions between the processes of adaptive behavior, neurological, endocrine and immune.
Among its premises assuming homeostasis or physiological balance as an integrated process involving the systems above mentioned.
Read more
Additionally, among the basics theme the re-mean is introduced, ie changing the direction, the function of a concept from a negative context carry a positive meaning, so that from the PNIT no disease is seen as a problem but as a situation to solve. The patient then transmits the importance of which will come.
Primary objective:
To investigate whether patients on PNIT have a higher proportion of patients achieving disease control (<7% in glycosylated hemoglobin (HBAC1) and quality of life compared with conventional treatment patients.
Methodology:
quasi-experimental, simple blind, simple blind, parallel, phase III clinical trial The investigators will follow a group of patients with type 2 diabetes mellitus durgin three months with an interim analysis a month after receiving the intervention (two visits) During each visit a trained PNIT physician assess the effectiveness, safety and quality of life of each patient.
The investigators will include male or female patients aged 18 years-old with diabetes mellitus type II in any severity, uncontrolled (> 7% Glycosilated Haemoglobin (HbAc1)) and any treatment regimen included.
The patients are not allocated by a random process and the investigators will have a convenience sample
The investigators will perform an intention to treat analysis, patients will be analyzed according to the intervention received even if this was different from the one they were assigned.
- Conditions
- Diabetes Mellitus, Type 2
- Being tested
- psychoneuroimmune therapy, Conventional treatment
- 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.
psychoneuroimmune therapyBehavioural
Also called Solarte Technique
Conventional treatmentDrug
Actual diabetes treatment in each participant
| Study group | Role | What they receive |
|---|---|---|
| Conventional treatment + PNIT | Other | PNIT: Psychoneuroimmuno therapy Conventional treatment: Usual treatment that each diabetic patient recieved Receives: Behavioral: psychoneuroimmune therapy |
| Conventional treatment | Active comparator | Conventional treatment: Usual treatment that each diabetic patient recieved Receives: Drug: Conventional treatment |
What is being measured
The primary outcome is the main question the study is designed to answer.
glycosylated hemoglobin (HbAc1 %)
Measured: 3 months
Secondary outcomes (4)
Adverse events
Measured: 3 months
Fasting Plasma Glucose (mmol/L)
Measured: 3 months
Quality of life in participants in each arm
Measured: 3 months
Follow-up lost
Measured: 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Sep 2015 (estimated)
- Study startSep 2015
- Primary completionSep 2016 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Diabetes Mellitus, Type 2Studies 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
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 500 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Fundación Salutia
- Sponsor type
- University, hospital or other
- Collaborators
- Coomeva E.P.S, Sinergia
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02536820
- Sponsor's protocol ID
- PNIT2015
- Acronym
- PNIT
- Status last verified
- Aug 2015
- First submitted
- 28 Aug 2015
- Last updated
- 1 Sep 2015
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 1 Sep 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Psychoneuroimmunology Therapy in Uncontrolled Diabetic Patients: A Quasi-experimental Study
- ClinicalTrials.gov ID
- NCT02536820
- Acronym / sponsor ID
- PNIT / PNIT2015
- Conditions
- Diabetes Mellitus, Type 2
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 500 participants (estimated)
- Lead sponsor
- Fundación SalutiaUniversity, hospital or other
- Collaborators
- Coomeva E.P.S, Sinergia
- Study start
- Sep 2015
- Primary completion
- Sep 2016 (estimated)
- First posted
- 1 Sep 2015 (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 Psychoneuroimmunotherapy (PNIT) is the study, modification and implementation of the interactions between the processes of adaptive behavior, neurological, endocrine and immune.
Among its premises assuming homeostasis or physiological balance as an integrated process involving the systems above mentioned.
Additionally, among the basics theme the re-mean is introduced, ie changing the direction, the function of a concept from a negative context carry a positive meaning, so that from the PNIT no disease is seen as a problem but as a situation to solve. The patient then transmits the importance of which will come.
Primary objective:
To investigate whether patients on PNIT have a higher proportion of patients achieving disease control (<7% in glycosylated hemoglobin (HBAC1) and quality of life compared with conventional treatment patients.
Methodology:
quasi-experimental, simple blind, simple blind, parallel, phase III clinical trial The investigators will follow a group of patients with type 2 diabetes mellitus durgin three months with an interim analysis a month after receiving the intervention (two visits) During each visit a trained PNIT physician assess the effectiveness, safety and quality of life of each patient.
The investigators will include male or female patients aged 18 years-old with diabetes mellitus type II in any severity, uncontrolled (> 7% Glycosilated Haemoglobin (HbAc1)) and any treatment regimen included.
The patients are not allocated by a random process and the investigators will have a convenience sample
The investigators will perform an intention to treat analysis, patients will be analyzed according to the intervention received even if this was different from the one they were assigned.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Conventional treatment + PNIT | Other | Behavioral: psychoneuroimmune therapyPNIT: Psychoneuroimmuno therapy Conventional treatment: Usual treatment that each diabetic patient recieved |
| Conventional treatment | Active comparator | Drug: Conventional treatmentConventional treatment: Usual treatment that each diabetic patient recieved |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Patients who wish to participate with informed consent sign.
- Diagnosed with uncontrolled diabetes mellitus type II (> 7% of HbAc1) at least six months before starting the study
- No change in medication at least three months before starting the study.
- Participants with acceptable electrocardiographic results acceptable at the study start.
Key exclusion criteria (4 listed)
- Pregnant women, or planning to become pregnant during the study period.
- History of severe liver failure.
- Participants requiring elective surgeries or other procedures requiring general anesthesia for the duration of the study.
- Participants who are participating in other clinical trials involving drugs or who have participated in another clinical trial in the last three months.
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 |
|---|---|---|
| psychoneuroimmune therapyAlso: Solarte Technique | Behavioural | Conventional treatment + PNIT |
| Conventional treatmentActual diabetes treatment in each participant | Drug | Conventional treatment |
Primary outcome
glycosylated hemoglobin (HbAc1 %)
Time frame: 3 months
4 secondary outcomes
Adverse events
Time frame: 3 months
Fasting Plasma Glucose (mmol/L)
Time frame: 3 months
Quality of life in participants in each arm
Time frame: 3 months
Follow-up lost
Time frame: 3 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Sep 2015.
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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.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing psychoneuroimmune therapy and Conventional treatment in people with Diabetes Mellitus, Type 2, run by Fundación Salutia.
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 4 inclusion and 4 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: status not confirmed, as of the sponsor's last update on 1 Sep 2015. 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. 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?
Results are not available in the source record.
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?
glycosylated hemoglobin (HbAc1 %) (time frame: 3 months). 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 1 Sep 2015.