Diabetes Mellitus, Type 2 Clinical Trial
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.
n/a
Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Subject), Primary Purpose: Treatment
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