Ignite Creation Date:
2024-05-06 @ 3:49 PM
Last Modification Date:
2024-10-26 @ 1:57 PM
Study NCT ID:
NCT04763525
Status:
COMPLETED
Last Update Posted:
2021-02-21
First Post:
2021-02-09
Brief Title:
Efficacy of Pythagorean Self-Awareness for Aging Biomarkers Improvement in T2D Patients and Healthy Individuals
Sponsor:
National and Kapodistrian University of Athens
Organization:
National and Kapodistrian University of Athens
Study Overview
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
Status:
COMPLETED
Status Verified Date:
2021-02
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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 4102018 to 26112019 The study protocol was approved by the Ethics Committee of the Laiko Hospital protocol number 51345-4-19 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
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 Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None