Effect of Cognitive Behavioral Therapy and Phototherapy on Glycosylated Hemoglobin, CLOCK Genes and Quality of Life in Patients With Type 2 Diabetes Mellitus and Insomnia
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 23
- 试验地点
- 1
- 主要终点
- Insomnia
研究概览
简要总结
Purpose: To analyze the efficiency of Cognitive Behavioral Intervention in combination with phototherapy to reduce insomnia and improve glycemic control, quality of life, and CLOCK genes expression in patients with type 2 diabetes mellitus. Methods: Clinical, quasi-experimental, pre-post, explanatory, non-probability sampling. Subjects were invited to participate in Hospital Juárez de México. They received eight sessions of Cognitive Behavioral Therapy in combination with phototherapy. The assessment was carried out with validated instruments for Mexican population and gene expression was evaluated by real-time PCR.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 40 Years 至 60 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Have a medical record in the Endocrinology service at the Hospital Juarez de Mexico
- •Patients with type 2 diabetes mellitus
- •Age between 40 and 60 years
- •Present Insomnia based on the criteria of The Diagnostic and Diagnostic Manual Statistics of Mental Disorders (DSM-V) which defines insomnia such as predominant dissatisfaction with the quantity or quality of sleep, associated with one (or more) of the following symptoms: a) Difficulty starting the dream,or b) Difficulty maintaining sleep, characterized by awakenings frequent and c) Waking up early in the morning with inability to return to sleep; with clinically significant distress or social impairment, work, educational, academic, behavioral or other important areas of operation, at least three nights a week, for a minimum of three months even with favorable sleeping conditions.
- •Sign an informed consent letter and agree to participate in the study.
- •Accept taking a blood sample pre and post intervention
- •HbA1c level above 6.1% (120 mg/dL;7 mmol/L) or BMI less than 34.9 units
排除标准
- •Do not agree to sign the informed consent
- •Have a previous psychiatric diagnosis
- •Have neurological disorders
- •Be diagnosed with type 1 diabetes mellitus or BMI greater than 35 units
- •Missing more than 20% of the sessions (2 sessions)
结局指标
主要结局
Insomnia
时间窗: 0 and 3 months
The Insomnia Scale Athens is made up of eight items, with a scale of Likert type with four response options that ranges of 0 (no sleep-related problem) to 3 (high presence of sleep problems). The first five items identify insomnia and the last three are aimed at identifying consequences of insomnia to the next day
Quality of life
时间窗: 0 and 3 months
Quality of life questionnaire D39, contains 39 closed items that are grouped into five sections: Energy-Mobility (15 items: 3, 7, 9, 10, 11, 12, 13, 16, 25, 29, 32, 33, 34, 35 and 36), Diabetes control (12 items: 1, 4, 5, 14, 15, 17, 18, 24, 27, 28, 31 and 39); Anxiety-worry (four items: 2, 6, 8 and 22), Social burden (five items: 19, 20, 26, 37 and 38) and Sexual functioning (three items: 21, 23 and 30)
Sleep quality
时间窗: 0 and 3 months
Pittsburg sleep quality questionnaire,It provides a global rating in 7 components, in no problem, good quality, poor quality and very poor quality of sleep, it consists of 19 multiple option items.
Glycosylated hemoglobin
时间窗: 0 and 3 months
A venous blood sample will be taken and analyzed in the clinical analysis laboratory.
次要结局
- Gene expression analysis of PER2(0 and 3 months)
- Gene expression analysis of BMAL1(0 and 3 months)
- Gene expression analysis of PER1(0 and 3 months)
- Gene expression analysis of CLOCK(0 and 3 months)
研究者
Nadia Mabel Pérez Vielma
professor and researcher
Centro Interdisciplinario de Ciencias de la Salud Unidad Santo Tomás