Psychoneuroimmunology Therapy in Uncontrolled Diabetic Patients: A Quasi-experimental Study (PNIT)
Primary Purpose
Diabetes Mellitus, Type 2
Status
Unknown status
Phase
Phase 3
Locations
Study Type
Interventional
Intervention
psychoneuroimmune therapy
Conventional treatment
Sponsored by

About this trial
This is an interventional treatment trial for Diabetes Mellitus, Type 2
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.
Sites / Locations
Arms of the Study
Arm 1
Arm 2
Arm Type
Other
Active Comparator
Arm Label
Conventional treatment + PNIT
Conventional treatment
Arm Description
PNIT: Psychoneuroimmuno therapy Conventional treatment: Usual treatment that each diabetic patient recieved
Conventional treatment: Usual treatment that each diabetic patient recieved
Outcomes
Primary Outcome Measures
glycosylated hemoglobin (HbAc1 %)
Secondary Outcome Measures
Adverse events
Fasting Plasma Glucose (mmol/L)
Quality of life in participants in each arm
Follow-up lost
Full Information
NCT ID
NCT02536820
First Posted
August 28, 2015
Last Updated
August 31, 2015
Sponsor
Fundación Salutia
Collaborators
Coomeva E.P.S, Sinergia
1. Study Identification
Unique Protocol Identification Number
NCT02536820
Brief Title
Psychoneuroimmunology Therapy in Uncontrolled Diabetic Patients: A Quasi-experimental Study
Acronym
PNIT
Study Type
Interventional
2. Study Status
Record Verification Date
August 2015
Overall Recruitment Status
Unknown status
Study Start Date
September 2015 (undefined)
Primary Completion Date
September 2016 (Anticipated)
Study Completion Date
undefined (undefined)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Fundación Salutia
Collaborators
Coomeva E.P.S, Sinergia
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Diabetes Mellitus, Type 2
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
Participant
Allocation
Non-Randomized
Enrollment
500 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Conventional treatment + PNIT
Arm Type
Other
Arm Description
PNIT: Psychoneuroimmuno therapy Conventional treatment: Usual treatment that each diabetic patient recieved
Arm Title
Conventional treatment
Arm Type
Active Comparator
Arm Description
Conventional treatment: Usual treatment that each diabetic patient recieved
Intervention Type
Behavioral
Intervention Name(s)
psychoneuroimmune therapy
Other Intervention Name(s)
Solarte Technique
Intervention Type
Drug
Intervention Name(s)
Conventional treatment
Intervention Description
Actual diabetes treatment in each participant
Primary Outcome Measure Information:
Title
glycosylated hemoglobin (HbAc1 %)
Time Frame
3 months
Secondary Outcome Measure Information:
Title
Adverse events
Time Frame
3 months
Title
Fasting Plasma Glucose (mmol/L)
Time Frame
3 months
Title
Quality of life in participants in each arm
Time Frame
3 months
Title
Follow-up lost
Time Frame
3 months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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.
12. IPD Sharing Statement
Learn more about this trial
Psychoneuroimmunology Therapy in Uncontrolled Diabetic Patients: A Quasi-experimental Study
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