Efficacy of Pythagorean Self-Awareness for Aging Biomarkers Improvement, in T2D Patients and Healthy Individuals.
- Conditions
- Telomere ShorteningType 2 Diabetes Mellitus
- Interventions
- Behavioral: Pythagorean Self-Awareness Intervention(PSAI)
- Registration Number
- NCT04763525
- Lead Sponsor
- National and Kapodistrian University of Athens
- 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.
- Detailed 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 & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 48
- 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
- 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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Intervention group Pythagorean Self-Awareness for healthy individuals Pythagorean Self-Awareness Intervention(PSAI) N=27 healthy individuals Intervention group Pythagorean Self-Awareness in patients with type 2 diabetes Pythagorean Self-Awareness Intervention(PSAI) N=21 patients with type 2 diabetes
- Primary Outcome Measures
Name Time Method Determination of telomeres' length 6 months Extracted DNA from Peripheral blood mononuclear cells isolated from total blood
Determination of 20S proteasome concentration 6 months Protein extracts from Peripheral blood mononuclear cells isolated from total blood
Healthy Lifestyle and Personal Control Questionnaire 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.
Glycosylated haemoglobin 6 months total blood
- Secondary Outcome Measures
Name Time Method Hair cortisol concentration 6 months Hair specimens from the posterior vertex of the scalp, three cm proximal to scalp
Total Body Water 6 months Total Body Water will be reported in percent and it will be measured by the device TANITA BC418 (Tanita Cooperation, Tokyo, Japan),
Fat Free Mass 6 months Fat Free Mass will be reported in kilograms,and it will be measured by the device TANITA BC418 (Tanita Cooperation, Tokyo, Japan),
Fat Mass 6 months Fat Mass will be reported in percentage and it will be measured by the device TANITA BC418 (Tanita Cooperation, Tokyo, Japan),
Visceral fat 6 months Visceral fat will be reported in cm \^2 and it will be measured by the device TANITA BC418 (Tanita Cooperation, Tokyo, Japan)
Trunk fat 6 months Trunk fat will be reported in percentage and it will be measured by the device TANITA BC418 (Tanita Cooperation, Tokyo, Japan)
Body Mass Index 6 months Weight and height will be combined to report BMI in kg/m\^2
Depression Anxiety Stress Scale 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.
Perceived Stress Scale 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.
Self-referential quality of sleep 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.
Self-referential Internal Health Locus of Control 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.
Self-referential External and chance Health Locus of Control 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.
Self-referential health locus of control Powerful others 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.
Evaluation of verbal memory 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.
Evaluation of visuospatial memory 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.
Evaluation of speed processing information 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.
Fatigue 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.
Perimeter of the waist 6 months Perimeter will be reported in centimeters
Perimeter of the neck 6 months Perimeter will be reported in centimeters
Perimeter of the hips 6 months Perimeter will be reported in centimeters
Extracellular water 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
Intracellular water 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
Trial Locations
- Locations (1)
General University Laiko Hospital
🇬🇷Athens, Greece