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NCT Number: NCT04763525

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

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.

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Key information

Conditions

Type 2 Diabetes Mellitus Diabetes Mellitus Diabetes Mellitus, Type 2 Endocrine System Diseases Glucose Metabolism Disorders Metabolic Diseases Nutritional and Metabolic Diseases Telomere Shortening

Age range

19 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

General University Laiko Hospital

Athens, 11527, Greece

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Pythagorean Self-Awareness Intervention(PSAI)

Behavioral

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.

Primary outcomes

  1. Determination of telomeres' length

    Time frame: 2 months

    Extracted DNA from Peripheral blood mononuclear cells isolated from total blood

  2. Determination of telomeres' length

    Time frame: 6 months

    Extracted DNA from Peripheral blood mononuclear cells isolated from total blood

  3. Determination of 20S proteasome concentration

    Time frame: 6 months

    Protein extracts from Peripheral blood mononuclear cells isolated from total blood

  4. Healthy Lifestyle and Personal Control Questionnaire

    Time frame: 6 months

    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.

  5. Glycosylated haemoglobin

    Time frame: 6 months

    total blood

Secondary outcomes

  1. Hair cortisol concentration

    Time frame: 6 months

    Hair specimens from the posterior vertex of the scalp, three cm proximal to scalp

  2. Total Body Water

    Time frame: 6 months

    Total Body Water will be reported in percent and it will be measured by the device TANITA BC418 (Tanita Cooperation, Tokyo, Japan),

  3. Fat Free Mass

    Time frame: 6 months

    Fat Free Mass will be reported in kilograms,and it will be measured by the device TANITA BC418 (Tanita Cooperation, Tokyo, Japan),

  4. Fat Mass

    Time frame: 6 months

    Fat Mass will be reported in percentage and it will be measured by the device TANITA BC418 (Tanita Cooperation, Tokyo, Japan),

  5. Visceral fat

    Time frame: 6 months

    Visceral fat will be reported in cm ^2 and it will be measured by the device TANITA BC418 (Tanita Cooperation, Tokyo, Japan)

  6. Trunk fat

    Time frame: 6 months

    Trunk fat will be reported in percentage and it will be measured by the device TANITA BC418 (Tanita Cooperation, Tokyo, Japan)

  7. Body Mass Index

    Time frame: 6 months

    Weight and height will be combined to report BMI in kg/m^2

  8. Depression Anxiety Stress Scale

    Time frame: 6 months

    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.

  9. Perceived Stress Scale

    Time frame: 6 months

    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.

  10. Self-referential quality of sleep

    Time frame: 6 months

    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.

  11. Self-referential Internal Health Locus of Control

    Time frame: 6 months

    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.

  12. Self-referential External and chance Health Locus of Control

    Time frame: 6 months

    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.

  13. Self-referential health locus of control Powerful others

    Time frame: 6 months

    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.

  14. Evaluation of verbal memory

    Time frame: 6 months

    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.

  15. Evaluation of visuospatial memory

    Time frame: 6 months

    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.

  16. Evaluation of speed processing information

    Time frame: 6 months

    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.

  17. Fatigue

    Time frame: 6 months

    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.

  18. Perimeter of the waist

    Time frame: 6 months

    Perimeter will be reported in centimeters

  19. Perimeter of the neck

    Time frame: 6 months

    Perimeter will be reported in centimeters

  20. Perimeter of the hips

    Time frame: 6 months

    Perimeter will be reported in centimeters

  21. Extracellular water

    Time frame: 6 months

    Extracellular water will be reported in percentage and with be assessed by a device of bioelectrical impedance technology by BIOTEKNA©, Biomedical Technologies, Venice, Italy

  22. Intracellular water

    Time frame: 6 months

    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

Sponsors and collaborators

Lead sponsor

National and Kapodistrian University of Athens

Other

Collaborators

  • Aghia Sophia Children's Hospital of Athens
  • Laikο General Hospital, Athens
  • National Hellenic Research Foundation
  • University of Thessaly

Registry information

Official study title

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.

Important dates

Study start
2018
Primary completion
2019
Study completion
2019
First posted
Feb 21, 2021
Registry last updated
Feb 21, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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