Clinical trial NCT02536820: Psychoneuroimmunology Therapy in Uncontrolled Diabetic Patients: A Quasi-experimental Study
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE3
Conditions: Diabetes Mellitus, Type 2
Lead sponsor: Fundación Salutia
Sponsor class: OTHER
Collaborators: name: Coomeva E.P.S
name: Sinergia
First posted: 2015-09-01
Enrollment: 500
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief 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.

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.


Eligibility criteria: Inclusion Criteria:

* 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.

Exclusion Criteria:

* 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.

Primary outcomes:
measure: glycosylated hemoglobin (HbAc1 %)
timeFrame: 3 months
Secondary outcomes:
measure: Adverse events
timeFrame: 3 months
measure: Fasting Plasma Glucose (mmol/L)
timeFrame: 3 months
measure: Quality of life in participants in each arm
timeFrame: 3 months
measure: Follow-up lost
timeFrame: 3 months
Other outcomes:
Locations:
Study officials:
References: