Psychoneuroimmunology Therapy in Uncontrolled Diabetic Patients: A Quasi-experimental Study

Diabetes Mellitus, Type 2 Clinical Trial

— PNIT  

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT02536820
• Other study ID #: PNIT2015
• Status: Not yet recruiting
• Phase: Phase 3
• First received: August 28, 2015
• Last updated: August 31, 2015
• Start date: September 2015

Study information

• Verified date: August 2015
• Source: Fundación Salutia
• Contact: n/a
• Is FDA regulated: No
• Health authority: Colombia: Institutional Review Board
• Study type: Interventional

Clinical 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.

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 500
• Est. primary completion date: September 2016
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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.

Study Design

Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Subject), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Diabetes Mellitus, Type 2

Intervention

Behavioral:
• psychoneuroimmune therapy

Drug:
• Conventional treatment
Actual diabetes treatment in each participant

Locations

Country	Name	City	State
n/a

Sponsors (3)

Lead Sponsor	Collaborator
Fundación Salutia	Coomeva E.P.S, Sinergia

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	glycosylated hemoglobin (HbAc1 %)		3 months	No
Secondary	Adverse events		3 months	Yes
Secondary	Fasting Plasma Glucose (mmol/L)		3 months	No
Secondary	Quality of life in participants in each arm		3 months	No
Secondary	Follow-up lost		3 months	No