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

Type 2 Diabetes Mellitus Clinical Trial

Official 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.

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04763525
• Other study ID #: 5134/5-4-19
• Status: Completed
• Phase: N/A
• Start date: October 4, 2018
• Est. completion date: November 26, 2019

Study information

• Verified date: February 2021
• Source: National and Kapodistrian University of Athens
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Description:

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 48
• Est. completion date: November 26, 2019
• Est. primary completion date: November 26, 2019
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 19 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Diabetes Mellitus
• Diabetes Mellitus, Type 2
• Telomere Shortening
• Type 2 Diabetes Mellitus

Intervention

Behavioral:
• Pythagorean Self-Awareness Intervention(PSAI)
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.

Locations

Country	Name	City	State
Greece	General University Laiko Hospital	Athens

Sponsors (5)

Lead Sponsor	Collaborator
National and Kapodistrian University of Athens	Aghia Sophia Children's Hospital of Athens, Laik? General Hospital, Athens, National Hellenic Research Foundation, Athens, Greece, University of Thessaly

Country where clinical trial is conducted

Greece, 

References & Publications (9)

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. — View Citation

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. Epub 2003 May 7. — View Citation

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. — View Citation

de Magalhães 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. Review. — View Citation

Díaz-Ruiz A, Guzmán-Ruiz R, Moreno NR, García-Rios A, Delgado-Casado N, Membrives A, Túnez I, El Bekay R, Fernández-Real JM, Tovar S, Diéguez C, Tinahones FJ, Vázquez-Martínez R, López-Miranda J, Malagón 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. — View Citation

López-Otín 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. Review. — View Citation

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. — View Citation

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. — View Citation

Weber D, Stuetz W, Toussaint O, Debacq-Chainiaux F, Dollé MET, Jansen E, Gonos ES, Franceschi C, Sikora E, Hervonen A, Breusing N, Sindlinger T, Moreno-Villanueva M, Bürkle 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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Determination of telomeres' length	Extracted DNA from Peripheral blood mononuclear cells isolated from total blood	2 months
Primary	Determination of telomeres' length	Extracted DNA from Peripheral blood mononuclear cells isolated from total blood	6 months
Primary	Determination of 20S proteasome concentration	Protein extracts from Peripheral blood mononuclear cells isolated from total blood	6 months
Primary	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
Primary	Glycosylated haemoglobin	total blood	6 months
Secondary	Hair cortisol concentration	Hair specimens from the posterior vertex of the scalp, three cm proximal to scalp	6 months
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	Body Mass Index	Weight and height will be combined to report BMI in kg/m^2	6 months
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	Perimeter of the waist	Perimeter will be reported in centimeters	6 months
Secondary	Perimeter of the neck	Perimeter will be reported in centimeters	6 months
Secondary	Perimeter of the hips	Perimeter will be reported in centimeters	6 months
Secondary	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
Secondary	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