Association of Perceived Stress and Negative Thoughts With Metabolic Biomarkers and Inflammatory Diseases in People With Type 2 Diabetes Mellitus and Healthy Subjects
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 40
- 试验地点
- 2
- 主要终点
- Salivary cortisol
研究概览
简要总结
The purpose of this study is to determine the effect of measured and induced negative feelings on glucose, tumor necrosis factor alpha, and cortisol levels in healthy participants and participants with type 2 diabetes mellitus.
详细描述
Depression and Diabetes are two pathologies that are frequently comorbid. Stress and negative thoughts are part of both. The biological correlates of psychological and emotional life are not yet fully clarified, so in this study we wonder about the association between tumor necrosis factor alpha, cortisol, and peripheral glucose levels with depression stress, measured negative thoughts, and induced guilt.This is a randomized intervention study. At baseline, participants complete the Beck Depression Inventory, the Automatic Negative Thoughts Scale (ATQ-N), and the Perceived Stress Scale (PSS-14). The intervention consists of a written task about situations that involved feelings of guilt or neutral situations. Saliva and dextrostix samples are taken before the 20-minute written task, at the end, dextrostix and saliva samples are performed again, finally a blood sample is taken.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Basic Science
- 盲法
- Single (Outcomes Assessor)
入排标准
- 年龄范围
- 30 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Written, informed consent.
- •30 to 65 years of age.
- •Current diagnosis of Diabetes mellitus type 2 without diabetic foot.
- •Healthy volunteers.
- •Ability to read and write.
排除标准
- •Other current or past chronic disease diagnoses.
- •Current use of antidepressants or other psychiatric medications.
- •Steroid medication.
- •Consumption of tobacco or alcohol in the last 24 hours.
- •Previous diagnosis of autoimmune diseases
结局指标
主要结局
Salivary cortisol
时间窗: Sample collection is two times during a single day for each participant, with an interval of 20 minutes. Since it will be measured in fasting, it will take place between 8:00 a.m. and 9:00 a.m.
mg/dL
Glucose levels
时间窗: Sample collection is two times during a single day for each participant, with an interval of 20 minutes. Since it will be measured in fasting, it will take place between 8:00 a.m. and 9:00 a.m.
mg/dL
Salivary Tumor Necrosis Factor alpha
时间窗: Sample collection is two times during a single day for each participant, with an interval of 20 minutes. It will take place between 8:00 a.m. and 9:00 a.m.
mg/dL
次要结局
- Perceived stress(This variable is measured in a single day and represents the week prior to the study.)
- Depression(This variable is measured in a single day and represents the week prior to the study.)
- Negative thoughts(This variable is measured in a single day and represents the month prior to the study.)
研究者
Francisco Carlos López Marquez
Director of Biomedical research center, Faculty of Medicine, Torreón unit.
Universidad Autonoma de Coahuila