Efficacy of Pythagorean Self-Awareness for Aging Biomarkers Improvement, in T2D Patients and Healthy Individuals.

Study Overview
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Brief Summary
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The present study explored the effects of the implementation of the Pythagorean Self Awareness Intervention (PSAI) on the dynamics of stress-related aging factors of immune cells in healthy volunteers and a cohort patients with type 2 diabetes mellitus . The primary aim was to evaluate the effectiveness of PSAI on two key biomarkers of biological age, telomere length and proteasome levels, indicative of the crosstalk between cellular oxidative status and replicative potential, with respect to metabolic, hormonal and mental status changes. Secondary aims of this study included reduction of depression, perceived stress, anxiety and the establishment of lifestyle changes to enhance the quality of everyday life, including better quality of sleep, eating behaviours and an overall healthier status.

Detailed Description
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Study design This non randomized non blinded parallel trial was conducted at the Laiko Hospital of Athens, Diabetes Centre, First Department of Propaedeutic Internal Medicine of Attica, Greece, from 4.10.2018 to 26.11.2019. The study protocol was approved by the Ethics Committee of the Laiko Hospital (protocol number 5134/5-4-19) and was in accordance with the declaration of Helsinki. All participants were enlisted in the study only after being fully informed by the researcher about the aims and procedures of the research and submitting written consent. Procedures Patients eligible for the above mentioned criteria were randomized in two groups: the group of healthy adult volunteers, and adults with type 2 diabetes who attended the outpatient diabetes clinic. This study was non-blinded, as patients and researchers were aware of the group assignment.

Official Title
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Stress and Biomarkers of Aging: a Novel Stress Management Program With the Cognitive Restructuring Method Pythagorean Self-Awareness Intervention in Healthy Individuals and in Subjects With Type 2 Diabetes Mellitus.

Conditions
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Type 2 Diabetes Mellitus, Telomere Shortening

Intervention / Treatment
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* Behavioral: Pythagorean Self-Awareness Intervention(PSAI)


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: adequate knowledge of the Greek language For participants with T2DM, a minimum of 3-month stable antidiabetic, hypolipidemic and antihypertensive treatment habitants of Athens, Greece Exclusion Criteria: participation in other stress management program corticosteroid intake diagnosis of psychiatric co-morbidity or autoimmune disease change in antidiabetic, hypolipidemic, and antihypertensive treatment within the previous 3 months patients with type 2 diabetes treated with insulin

Ages Eligible for Study
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Minimum Age: 19 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Intervention group Pythagorean Self-Awareness in patients with type 2 diabetes<br>N=21 patients with type 2 diabetes | Behavioral: Pythagorean Self-Awareness Intervention(PSAI)<br>* The PSAI is a mental, stress-management technique that promotes self-awareness, cognitive reconstruction and self-improvement based on the Golden Verses moral framework of the ancient Greek philosopher Pythagoras. The individual must practice the technique twice daily( at bed-time and in the morning, every day, at home) and through a 3-stage internal dialogue (recall of daily events, inspection of related thoughts and emotions and self-appraisal)is encouraged to detect wrong choices and unhealthy behaviours and initiate self-correction towards a healthier lifestyle.<br>|
| Experimental: Intervention group Pythagorean Self-Awareness for healthy individuals<br>N=27 healthy individuals | Behavioral: Pythagorean Self-Awareness Intervention(PSAI)<br>* The PSAI is a mental, stress-management technique that promotes self-awareness, cognitive reconstruction and self-improvement based on the Golden Verses moral framework of the ancient Greek philosopher Pythagoras. The individual must practice the technique twice daily( at bed-time and in the morning, every day, at home) and through a 3-stage internal dialogue (recall of daily events, inspection of related thoughts and emotions and self-appraisal)is encouraged to detect wrong choices and unhealthy behaviours and initiate self-correction towards a healthier lifestyle.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Determination of telomeres' length | Extracted DNA from Peripheral blood mononuclear cells isolated from total blood | 2 months | 
| Determination of telomeres' length | Extracted DNA from Peripheral blood mononuclear cells isolated from total blood | 6 months | 
| Determination of 20S proteasome concentration | Protein extracts from Peripheral blood mononuclear cells isolated from total blood | 6 months | 
| Healthy Lifestyle and Personal Control Questionnaire | Self-report questionnaire for the evaluation of a healthy lifestyle with the instrument Healthy Lifestyle and Personal Control Questionnaire that explores five dimensions of lifestyle (Organized Physical Exercise, Social Support and Mental Control, Daily Routine, Dietary Harm Avoidance, Dietary Healthy Habits).Scores range from 26 to 104 with higher scores indicating a healthier lifestyle. | 6 months | 
| Glycosylated haemoglobin | total blood | 6 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Hair cortisol concentration | Hair specimens from the posterior vertex of the scalp, three cm proximal to scalp | 6 months | 
| Total Body Water | Total Body Water will be reported in percent and it will be measured by the device TANITA BC418 (Tanita Cooperation, Tokyo, Japan), | 6 months | 
| Fat Free Mass | Fat Free Mass will be reported in kilograms,and it will be measured by the device TANITA BC418 (Tanita Cooperation, Tokyo, Japan), | 6 months | 
| Fat Mass | Fat Mass will be reported in percentage and it will be measured by the device TANITA BC418 (Tanita Cooperation, Tokyo, Japan), | 6 months | 
| Visceral fat | Visceral fat will be reported in cm ^2 and it will be measured by the device TANITA BC418 (Tanita Cooperation, Tokyo, Japan) | 6 months | 
| Trunk fat | Trunk fat will be reported in percentage and it will be measured by the device TANITA BC418 (Tanita Cooperation, Tokyo, Japan) | 6 months | 
| Body Mass Index | Weight and height will be combined to report BMI in kg/m^2 | 6 months | 
| Depression Anxiety Stress Scale | Self-referential symptoms of depression, anxiety and stress with the instrument Depression-Anxiety-Stress Scale-21 Three scores(Depression, Anxiety, Stress). Depression score ranging from 0 to 42, Anxiety score ranging from 0-42, Stress score ranging from 0-42. We expect reduction. | 6 months | 
| Perceived Stress Scale | Evaluation with the self-referential instrument the Perceived Stress Scale. Score ranging from 0 to 56 with higher score indicating higher perceived stress. We expect reduction. | 6 months | 
| Self-referential quality of sleep | Evaluation of sleep quality with the instrument Greek version Pittburgh Sleep Quality Index. Score ranging from 0 to 21. Score higher than 5 indicates poor sleep quality. We expect reduction. | 6 months | 
| Self-referential Internal Health Locus of Control | Evaluation of internal health locus with the instrument Health Locus of Control. Score ranging from 6 to 36 with higher scores indicating higher self-control over the individual's health. We expect increase. | 6 months | 
| Self-referential External and chance Health Locus of Control | Evaluation of External health locus of control and chance, with the instrument Health Locus of Control. Score ranging from 6 to 36 for each dimension. Higher score means that the individual perceives that his/her health is controlled by external factors and chance.We expect reduction. | 6 months | 
| Self-referential health locus of control Powerful others | Evaluation of health locus of control for Powerful others with the instrument Health Locus of Control. Score ranging from 6 to 36.Higher score means that the individual perceives that his/her health is controlled by powerful others such as health personnel.We expect reduction. | 6 months | 
| Evaluation of verbal memory | Assessment of verbal memory with the cognitive test California Verbal Learning test. Score ranging from 0 to 90 with higher score indicating better verbal memory. We expect increase. | 6 months | 
| Evaluation of visuospatial memory | Assessment of visuospatial memory with the cognitive test Brief Visuospatial Memory test-Revised. Score ranging from 0 to 36 with higher score indicating better visuospatial memory.We expect increase. | 6 months | 
| Evaluation of speed processing information | Assessment of speed processing of information with the cognitive test Symbol Digits Modality test. Score ranging from 0 to 95 with higher score indicating higher speed processing of information.We expect increase. | 6 months | 
| Fatigue | Assessment of physical, mental and brain fatigue with a visual analogue scale with minimum as 0 indicating no fatigue at all and maximum 10 indicating high degree of fatigue. We expect reduction. | 6 months | 
| Perimeter of the waist | Perimeter will be reported in centimeters | 6 months | 
| Perimeter of the neck | Perimeter will be reported in centimeters | 6 months | 
| Perimeter of the hips | Perimeter will be reported in centimeters | 6 months | 
| Extracellular water | Extracellular water will be reported in percentage and with be assessed by a device of bioelectrical impedance technology by BIOTEKNA©, Biomedical Technologies, Venice, Italy | 6 months | 
| Intracellular water | Intracellular water will be reported in percentage and it will be measured by a device of bioelectrical impedance technology by BIOTEKNA©, Biomedical Technologies, Venice, Italy | 6 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Stress physiology, behavioural intervention, stress management, type 2 diabetes, Pythagorean Self-Awareness