Type 2 Diabetes MellitusNCT04763525
Efficacy of Pythagorean Self-Awareness for Aging Biomarkers Improvement, in T2D Patients and Healthy Individuals.
A study testing Pythagorean Self-Awareness Intervention(PSAI) in people with Type 2 Diabetes Mellitus and Telomere Shortening, run by National and Kapodistrian University of Athens at 1 site in Greece.
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 . Read more about this study
- Who is it for?
- Ages 19 years and olderHealthy volunteers can take part
- Conditions the study is for
- Type 2 Diabetes Mellitus, Telomere Shortening
- What is being tested?
- Pythagorean Self-Awareness Intervention(PSAI)
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 48 participants
- Where
- 1 siteGreece
- Study dates
- 4 Oct 2018to 26 Nov 2019
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 19 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
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.
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.
Read the 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.
- Conditions
- Type 2 Diabetes Mellitus, Telomere Shortening
- Being tested
- Pythagorean Self-Awareness Intervention(PSAI)
- Keywords
- Stress physiology, behavioural intervention, stress management, type 2 diabetes, Pythagorean Self-Awareness
- Medical subject headings
- Diabetes Mellitus, Type 2
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Pythagorean Self-Awareness Intervention(PSAI)Behavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| Intervention group Pythagorean Self-Awareness in patients with type 2 diabetes | Experimental | N=21 patients with type 2 diabetes Receives: Behavioral: Pythagorean Self-Awareness Intervention(PSAI) |
| Intervention group Pythagorean Self-Awareness for healthy individuals | Experimental | N=27 healthy individuals Receives: Behavioral: Pythagorean Self-Awareness Intervention(PSAI) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Determination of telomeres' length
Extracted DNA from Peripheral blood mononuclear cells isolated from total blood
Measured: 2 months
Determination of telomeres' length
Extracted DNA from Peripheral blood mononuclear cells isolated from total blood
Measured: 6 months
Determination of 20S proteasome concentration
Protein extracts from Peripheral blood mononuclear cells isolated from total blood
Measured: 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.
Measured: 6 months
Glycosylated haemoglobin
total blood
Measured: 6 months
Secondary outcomes (22)
Hair cortisol concentration
Hair specimens from the posterior vertex of the scalp, three cm proximal to scalp
Measured: 6 months
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),
Measured: 6 months
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),
Measured: 6 months
Fat Mass
Fat Mass will be reported in percentage and it will be measured by the device TANITA BC418 (Tanita Cooperation, Tokyo, Japan),
Measured: 6 months
Visceral fat
Visceral fat will be reported in cm ^2 and it will be measured by the device TANITA BC418 (Tanita Cooperation, Tokyo, Japan)
Measured: 6 months
Trunk fat
Trunk fat will be reported in percentage and it will be measured by the device TANITA BC418 (Tanita Cooperation, Tokyo, Japan)
Measured: 6 months
Body Mass Index
Weight and height will be combined to report BMI in kg/m^2
Measured: 6 months
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.
Measured: 6 months
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.
Measured: 6 months
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.
Measured: 6 months
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.
Measured: 6 months
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.
Measured: 6 months
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.
Measured: 6 months
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.
Measured: 6 months
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.
Measured: 6 months
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.
Measured: 6 months
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.
Measured: 6 months
Perimeter of the waist
Perimeter will be reported in centimeters
Measured: 6 months
Perimeter of the neck
Perimeter will be reported in centimeters
Measured: 6 months
Perimeter of the hips
Perimeter will be reported in centimeters
Measured: 6 months
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
Measured: 6 months
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
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Feb 2021
- Study start4 Oct 2018
- Primary completion26 Nov 2019
- Study completion26 Nov 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (9)Papers the sponsor has linked to this study.
- Other trials for Type 2 Diabetes MellitusStudies of the same condition, open and under way.
- More trials run by National and Kapodistrian University of AthensThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 48 participants (actual)
Sponsor and investigators
- Lead sponsor
- National and Kapodistrian University of Athens
- Sponsor type
- University, hospital or other
- Collaborators
- National Hellenic Research Foundation, Laikο General Hospital, Athens, Aghia Sophia Children's Hospital of Athens, University of Thessaly
- Responsible party
- Principal investigator, Christina Darviri, National and Kapodistrian University of Athens
- Investigators
- Christina Darviri, Principal investigator, National and Kapodistrian University of Athens
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04763525
- Sponsor's protocol ID
- 5134/5-4-19
- Status last verified
- Feb 2021
- First submitted
- 9 Feb 2021
- Last updated
- 21 Feb 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: The data will be made available upon study publication.
Publications
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.
PubMed 23746838de 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.
PubMed 28688962Weber 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.
PubMed 28804532Chondrogianni 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.
PubMed 12736271Puhlmann 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.
PubMed 31553468Diaz-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.
PubMed 25714483Tsoli 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.
PubMed 29609939Charalampopoulou 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.
PubMed 31901782Darviri 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.
PubMed 25253039
Study at a glance
From the registry record, last updated by the sponsor on 21 Feb 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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.
- ClinicalTrials.gov ID
- NCT04763525
- Acronym / sponsor ID
- 5134/5-4-19
- Conditions
- Type 2 Diabetes Mellitus, Telomere Shortening
- Keywords
- Stress physiology, behavioural intervention, stress management, type 2 diabetes, Pythagorean Self-Awareness
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 48 participants (actual)
- Lead sponsor
- National and Kapodistrian University of AthensUniversity, hospital or other
- Collaborators
- National Hellenic Research Foundation, Laikο General Hospital, Athens, Aghia Sophia Children's Hospital of Athens, University of Thessaly
- Study start
- 4 Oct 2018 (actual)
- Primary completion
- 26 Nov 2019 (actual)
- Study completion
- 26 Nov 2019 (actual)
- First posted
- 21 Feb 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Intervention group Pythagorean Self-Awareness in patients with type 2 diabetes | Experimental | Behavioral: Pythagorean Self-Awareness Intervention(PSAI)N=21 patients with type 2 diabetes |
| Intervention group Pythagorean Self-Awareness for healthy individuals | Experimental | Behavioral: Pythagorean Self-Awareness Intervention(PSAI)N=27 healthy individuals |
Who may qualify
- Ages
- 19 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (5 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 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. | Behavioural | Intervention group Pythagorean Self-Awareness for healthy individuals, Intervention group Pythagorean Self-Awareness in patients with type 2 diabetes |
Primary outcome
Determination of telomeres' length
Time frame: 2 months
Extracted DNA from Peripheral blood mononuclear cells isolated from total blood
Determination of telomeres' length
Time frame: 6 months
Extracted DNA from Peripheral blood mononuclear cells isolated from total blood
Determination of 20S proteasome concentration
Time frame: 6 months
Protein extracts from Peripheral blood mononuclear cells isolated from total blood
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.
Glycosylated haemoglobin
Time frame: 6 months
total blood
22 secondary outcomes
Hair cortisol concentration
Time frame: 6 months
Total Body Water
Time frame: 6 months
Fat Free Mass
Time frame: 6 months
Fat Mass
Time frame: 6 months
Visceral fat
Time frame: 6 months
Trunk fat
Time frame: 6 months
Body Mass Index
Time frame: 6 months
Depression Anxiety Stress Scale
Time frame: 6 months
Perceived Stress Scale
Time frame: 6 months
Self-referential quality of sleep
Time frame: 6 months
Self-referential Internal Health Locus of Control
Time frame: 6 months
Self-referential External and chance Health Locus of Control
Time frame: 6 months
Self-referential health locus of control Powerful others
Time frame: 6 months
Evaluation of verbal memory
Time frame: 6 months
Evaluation of visuospatial memory
Time frame: 6 months
Evaluation of speed processing information
Time frame: 6 months
Fatigue
Time frame: 6 months
Perimeter of the waist
Time frame: 6 months
Perimeter of the neck
Time frame: 6 months
Perimeter of the hips
Time frame: 6 months
Extracellular water
Time frame: 6 months
Intracellular water
Time frame: 6 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Feb 2021.
- Background: PubMed 23746838Lopez-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.
- Background: PubMed 28688962de 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.
- Background: PubMed 28804532Weber 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.
- Background: PubMed 12736271Chondrogianni 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.
- Background: PubMed 31553468Puhlmann 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.
- Background: PubMed 25714483Diaz-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.
- Background: PubMed 29609939Tsoli 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.
- Background: PubMed 31901782Charalampopoulou 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.
- Background: PubMed 25253039Darviri 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.
- Individual participant dataSharing planned: No. The data will be made available upon study publication.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Christina Darviri principal investigator
National and Kapodistrian University of Athens
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Pythagorean Self-Awareness Intervention(PSAI) in people with Type 2 Diabetes Mellitus and Telomere Shortening, run by National and Kapodistrian University of Athens at 1 site in Greece.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 21 Feb 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Greece. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Determination of telomeres' length (time frame: 2 months). The study lists 5 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04763525, which also lists 9 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 21 Feb 2021.