Efficacy of Pythagorean Self-Awareness for Aging Biomarkers Improvement, in T2D Patients and Heal… (NCT04763525) | Clinical Trial Compass
CompletedNot Applicable
Efficacy of Pythagorean Self-Awareness for Aging Biomarkers Improvement, in T2D Patients and Healthy Individuals.
Greece48 participantsStarted 2018-10-04
Plain-language 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.
Who can participate
Age range
19 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Determination of telomeres' length
Timeframe: 2 months
2
Determination of telomeres' length
Timeframe: 6 months
3
Determination of 20S proteasome concentration
Timeframe: 6 months
4
Healthy Lifestyle and Personal Control Questionnaire
Timeframe: 6 months
5
Glycosylated haemoglobin
Timeframe: 6 months
Trial details
NCT IDNCT04763525
SponsorNational and Kapodistrian University of Athens