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.
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 48
- 试验地点
- 1
- 主要终点
- Determination of telomeres' length
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 19 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •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
排除标准
- •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
研究组 & 干预措施
Intervention group Pythagorean Self-Awareness in patients with type 2 diabetes
N=21 patients with type 2 diabetes
干预措施: Pythagorean Self-Awareness Intervention(PSAI) (Behavioral)
Intervention group Pythagorean Self-Awareness for healthy individuals
N=27 healthy individuals
干预措施: Pythagorean Self-Awareness Intervention(PSAI) (Behavioral)
结局指标
主要结局
Determination of telomeres' length
时间窗: 6 months
Extracted DNA from Peripheral blood mononuclear cells isolated from total blood
Determination of 20S proteasome concentration
时间窗: 6 months
Protein extracts from Peripheral blood mononuclear cells isolated from total blood
Healthy Lifestyle and Personal Control Questionnaire
时间窗: 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
时间窗: 6 months
total blood
Determination of telomeres' length
时间窗: 2 months
Extracted DNA from Peripheral blood mononuclear cells isolated from total blood
次要结局
- Perimeter of the neck(6 months)
- Perimeter of the hips(6 months)
- Extracellular water(6 months)
- Intracellular water(6 months)
- Hair cortisol concentration(6 months)
- Total Body Water(6 months)
- Visceral fat(6 months)
- Fat Free Mass(6 months)
- Fat Mass(6 months)
- Trunk fat(6 months)
- Body Mass Index(6 months)
- Depression Anxiety Stress Scale(6 months)
- Perceived Stress Scale(6 months)
- Self-referential quality of sleep(6 months)
- Self-referential Internal Health Locus of Control(6 months)
- Self-referential External and chance Health Locus of Control(6 months)
- Self-referential health locus of control Powerful others(6 months)
- Evaluation of verbal memory(6 months)
- Evaluation of visuospatial memory(6 months)
- Evaluation of speed processing information(6 months)
- Fatigue(6 months)
- Perimeter of the waist(6 months)
研究者
Christina Darviri
Professor of Health Promotion-Prevention and Epidemiology
National and Kapodistrian University of Athens