Ignite Creation Date:
2025-12-25 @ 4:29 AM
Ignite Modification Date:
2026-02-20 @ 3:33 PM
Study NCT ID:
NCT02536820
Status:
UNKNOWN
Last Update Posted:
2015-09-01
First Post:
2015-08-28
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Psychoneuroimmunology Therapy in Uncontrolled Diabetic Patients: A Quasi-experimental Study
Sponsor:
Fundación Salutia
Organization:
Study Overview
Official Title:
None
Status:
UNKNOWN
Status Verified Date:
2015-08
Last Known Status:
NOT_YET_RECRUITING
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
PNIT
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.
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.
Detailed Description:
None
Study Oversight
Has Oversight DMC:
True
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: