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

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ClinicalTrials.gov Identifier: NCT02536820
Recruitment Status : Unknown
Verified August 2015 by Fundación Salutia.
Recruitment status was:  Not yet recruiting
First Posted : September 1, 2015
Last Update Posted : September 1, 2015
Sponsor:
Collaborators:
Coomeva E.P.S
Sinergia
Information provided by (Responsible Party):
Fundación Salutia

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.


Condition or disease Intervention/treatment Phase
Diabetes Mellitus, Type 2 Behavioral: psychoneuroimmune therapy Drug: Conventional treatment Phase 3

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 500 participants
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: Single (Participant)
Primary Purpose: Treatment
Study Start Date : September 2015
Estimated Primary Completion Date : September 2016

Arm Intervention/treatment
Conventional treatment + PNIT
PNIT: Psychoneuroimmuno therapy Conventional treatment: Usual treatment that each diabetic patient recieved
Behavioral: psychoneuroimmune therapy
Other Name: Solarte Technique

Active Comparator: Conventional treatment
Conventional treatment: Usual treatment that each diabetic patient recieved
Drug: Conventional treatment
Actual diabetes treatment in each participant




Primary Outcome Measures :
  1. glycosylated hemoglobin (HbAc1 %) [ Time Frame: 3 months ]

Secondary Outcome Measures :
  1. Adverse events [ Time Frame: 3 months ]
  2. Fasting Plasma Glucose (mmol/L) [ Time Frame: 3 months ]
  3. Quality of life in participants in each arm [ Time Frame: 3 months ]
  4. Follow-up lost [ Time Frame: 3 months ]


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.
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Responsible Party: Fundación Salutia
ClinicalTrials.gov Identifier: NCT02536820    
Other Study ID Numbers: PNIT2015
First Posted: September 1, 2015    Key Record Dates
Last Update Posted: September 1, 2015
Last Verified: August 2015
Additional relevant MeSH terms:
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Diabetes Mellitus, Type 2
Diabetes Mellitus
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases