Clinical trial NCT04763525: Efficacy of Pythagorean Self-Awareness for Aging Biomarkers Improvement, in T2D Patients and Healthy Individuals.
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.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Type 2 Diabetes Mellitus
Telomere Shortening
Keywords: Stress physiology
behavioural intervention
stress management
type 2 diabetes
Pythagorean Self-Awareness
Lead sponsor: National and Kapodistrian University of Athens
Sponsor class: OTHER
Collaborators: name: National Hellenic Research Foundation
name: Laikο General Hospital, Athens
name: Aghia Sophia Children's Hospital of Athens
name: University of Thessaly
First posted: 2021-02-21
Enrollment: 48
Sex: ALL
Minimum age (years): 19
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

Eligibility criteria: 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

Primary outcomes:
measure: Determination of telomeres' length
timeFrame: 2 months
measure: Determination of telomeres' length
timeFrame: 6 months
measure: Determination of 20S proteasome concentration
timeFrame: 6 months
measure: Healthy Lifestyle and Personal Control Questionnaire
timeFrame: 6 months
measure: Glycosylated haemoglobin
timeFrame: 6 months
Secondary outcomes:
measure: Hair cortisol concentration
timeFrame: 6 months
measure: Total Body Water
timeFrame: 6 months
measure: Fat Free Mass
timeFrame: 6 months
measure: Fat Mass
timeFrame: 6 months
measure: Visceral fat
timeFrame: 6 months
measure: Trunk fat
timeFrame: 6 months
measure: Body Mass Index
timeFrame: 6 months
measure: Depression Anxiety Stress Scale
timeFrame: 6 months
measure: Perceived Stress Scale
timeFrame: 6 months
measure: Self-referential quality of sleep
timeFrame: 6 months
measure: Self-referential Internal Health Locus of Control
timeFrame: 6 months
measure: Self-referential External and chance Health Locus of Control
timeFrame: 6 months
measure: Self-referential health locus of control Powerful others
timeFrame: 6 months
measure: Evaluation of verbal memory
timeFrame: 6 months
measure: Evaluation of visuospatial memory
timeFrame: 6 months
measure: Evaluation of speed processing information
timeFrame: 6 months
measure: Fatigue
timeFrame: 6 months
measure: Perimeter of the waist
timeFrame: 6 months
measure: Perimeter of the neck
timeFrame: 6 months
measure: Perimeter of the hips
timeFrame: 6 months
measure: Extracellular water
timeFrame: 6 months
measure: Intracellular water
timeFrame: 6 months
Other outcomes:
Locations:
city: Athens
country: Greece
facility: General University Laiko Hospital
Study officials:
affiliation: National and Kapodistrian University of Athens
name: Christina Darviri
role: PRINCIPAL_INVESTIGATOR
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