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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
Fundación Salutia
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Diabetes Mellitus, Type 2

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

    First Posted
    August 28, 2015
    Last Updated
    August 31, 2015
    Sponsor
    Fundación Salutia
    Collaborators
    Coomeva E.P.S, Sinergia
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    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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