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

NCT04763525 | Completed

• 1 other identifier: 5134/5-4-19
• Study Type: interventional
• Target: 48
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Type 2 Diabetes Mellitus; Telomere Shortening

Keywords

Stress physiology; behavioural intervention; stress management; type 2 diabetes; Pythagorean Self-Awareness

Outcome Measures

Primary Outcomes (5)

• 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 Outcomes (22)

• Hair cortisol concentration

  6 months

• Total Body Water

  6 months

• Fat Free Mass

  6 months

• Fat Mass

  6 months

• Visceral fat

  6 months

Study Arms (2)

Intervention group Pythagorean Self-Awareness in patients with type 2 diabetes

EXPERIMENTAL

N=21 patients with type 2 diabetes

Behavioral: Pythagorean Self-Awareness Intervention(PSAI)

Intervention group Pythagorean Self-Awareness for healthy individuals

EXPERIMENTAL

N=27 healthy individuals

Behavioral: Pythagorean Self-Awareness Intervention(PSAI)

Interventions

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.

Intervention group Pythagorean Self-Awareness for healthy individuals; Intervention group Pythagorean Self-Awareness in patients with type 2 diabetes

Eligibility Criteria

• Age: 19 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• National and Kapodistrian University of Athens: lead
• National Hellenic Research Foundation: collaborator
• Laikο General Hospital, Athens: collaborator
• Aghia Sophia Children's Hospital of Athens: collaborator
• University of Thessaly: collaborator

Study Sites (1)

General University Laiko Hospital

Athens, 11527, Greece

Location

Related Publications (9)

• Lopez-Otin C, Blasco MA, Partridge L, Serrano M, Kroemer G. The hallmarks of aging. Cell. 2013 Jun 6;153(6):1194-217. doi: 10.1016/j.cell.2013.05.039.

  PMID: 23746838 BACKGROUND

• de Magalhaes JP, Passos JF. Stress, cell senescence and organismal ageing. Mech Ageing Dev. 2018 Mar;170:2-9. doi: 10.1016/j.mad.2017.07.001. Epub 2017 Jul 5.

  PMID: 28688962 BACKGROUND

• Weber D, Stuetz W, Toussaint O, Debacq-Chainiaux F, Dolle MET, Jansen E, Gonos ES, Franceschi C, Sikora E, Hervonen A, Breusing N, Sindlinger T, Moreno-Villanueva M, Burkle A, Grune T. Associations between Specific Redox Biomarkers and Age in a Large European Cohort: The MARK-AGE Project. Oxid Med Cell Longev. 2017;2017:1401452. doi: 10.1155/2017/1401452. Epub 2017 Jul 19.

  PMID: 28804532 BACKGROUND

• Chondrogianni N, Stratford FL, Trougakos IP, Friguet B, Rivett AJ, Gonos ES. Central role of the proteasome in senescence and survival of human fibroblasts: induction of a senescence-like phenotype upon its inhibition and resistance to stress upon its activation. J Biol Chem. 2003 Jul 25;278(30):28026-37. doi: 10.1074/jbc.M301048200. Epub 2003 May 7.

  PMID: 12736271 BACKGROUND

• Puhlmann LMC, Valk SL, Engert V, Bernhardt BC, Lin J, Epel ES, Vrticka P, Singer T. Association of Short-term Change in Leukocyte Telomere Length With Cortical Thickness and Outcomes of Mental Training Among Healthy Adults: A Randomized Clinical Trial. JAMA Netw Open. 2019 Sep 4;2(9):e199687. doi: 10.1001/jamanetworkopen.2019.9687.

  PMID: 31553468 BACKGROUND

• Diaz-Ruiz A, Guzman-Ruiz R, Moreno NR, Garcia-Rios A, Delgado-Casado N, Membrives A, Tunez I, El Bekay R, Fernandez-Real JM, Tovar S, Dieguez C, Tinahones FJ, Vazquez-Martinez R, Lopez-Miranda J, Malagon MM. Proteasome Dysfunction Associated to Oxidative Stress and Proteotoxicity in Adipocytes Compromises Insulin Sensitivity in Human Obesity. Antioxid Redox Signal. 2015 Sep 1;23(7):597-612. doi: 10.1089/ars.2014.5939. Epub 2015 Mar 31.

  PMID: 25714483 BACKGROUND

• Tsoli S, Vasdekis S, Tigani X, Artemiadis A, Chrousos G, Darviri C. A novel cognitive behavioral treatment for patients with chronic insomnia: A pilot experimental study. Complement Ther Med. 2018 Apr;37:61-63. doi: 10.1016/j.ctim.2018.01.015. Epub 2018 Feb 1.

  PMID: 29609939 BACKGROUND

• Charalampopoulou M, Bacopoulou F, Syrigos KN, Filopoulos E, Chrousos GP, Darviri C. The effects of Pythagorean Self-Awareness Intervention on breast cancer patients undergoing adjuvant therapy: A pilot randomized controlled trial. Breast. 2020 Feb;49:210-218. doi: 10.1016/j.breast.2019.12.012. Epub 2019 Dec 20.

  PMID: 31901782 BACKGROUND

• Darviri C, Alexopoulos EC, Artemiadis AK, Tigani X, Kraniotou C, Darvyri P, Chrousos GP. The Healthy Lifestyle and Personal Control Questionnaire (HLPCQ): a novel tool for assessing self-empowerment through a constellation of daily activities. BMC Public Health. 2014 Sep 24;14:995. doi: 10.1186/1471-2458-14-995.

  PMID: 25253039 BACKGROUND

MeSH Terms

Conditions

Diabetes Mellitus, Type 2

Condition Hierarchy (Ancestors)

Diabetes Mellitus; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases

Study Officials

• Christina Darviri

  National and Kapodistrian University of Athens

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor of Health Promotion-Prevention and Epidemiology

Study Record Dates

• First Submitted: February 9, 2021
• First Posted: February 21, 2021
• Study Start: October 4, 2018
• Primary Completion: November 26, 2019
• Study Completion: November 26, 2019
• Last Updated: February 21, 2021

Record last verified: 2021-02

Data Sharing

• IPD Sharing: Will not share

Locations

GR (1)