Exploring the Relationship between Sleep Quality and Glycemic Control in Patients with Type 2 Diabetes Mellitus Using Actigraphy: A Prospective Study
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 128
- 试验地点
- 1
- 主要终点
- To explore the relationship between sleep quality (measured with Actigraphy) and glycemic control (measured in terms of glycated haemoglobin) in patients with type 2 diabetes mellitus
研究概览
简要总结
The aim of the project is to investigate the potential relationship between sleep quality, as measured by actigraphy, and level glycemic control in patients with type 2 diabetes mellitus. This project seeks to provide a better understanding of the potential impact of sleep quality on glycemic control in individuals with diabetes, which may help clinicians develop more effective management strategies.
Glycemic control refers to the ability of individuals with diabetes to regulate their blood sugar levels, which is crucial for preventing complications associated with the condition. Poor sleep quality has been linked to various health issues, including metabolic disorders like diabetes.
By using Actigraphy to measure sleep quality, the study can provide objective and accurate data on participants’ sleep patterns, which may be more reliable than self-reported data. Additionally, this study’s prospective design allows for the observation of changes in sleep quality and glycemic control over time, providing a more comprehensive understanding of the relationship between these variables.
Actigraphy is a non-invasive method of measuring sleep. Patients do not need to attach electrodes to their scalp, which is required for methods such as polysomnography. Patients can wear the device on their wrist, and it does not require any supervision during sleep, making it suitable for long-term monitoring of sleep quality. Actigraphy is relatively inexpensive compared to other methods such as polysomnography, which requires expensive equipment and trained technicians to monitor the patient during sleep.
Hence, we aimed to objectively measure sleep quality and duration by Actigraphy for objectively assess the sleep quality and find its possible association with glycemic control in patients suffering from type 2 diabetes mellitus.
The study objective is to explore the relationship between sleep quality (measured with Actigraphy) and glycemic control (measured in terms of glycated haemoglobin) in patients with type 2 diabetes mellitus and also to identify any factors that may confound or modify the relationship between sleep quality and glycemic control, such as age, gender, and body mass index (BMI), and body fat percentage.
研究设计
- 研究类型
- Observational
入排标准
- 年龄范围
- 18.00 Year(s) 至 65.00 Year(s)（—）
- 性别
- Female
入选标准
- •1.Adults aged 18 years to 65 years who have been diagnosed with Type 2 diabetes mellitus with a minimum of 6 months duration.
- •2.Patients who are able to provide informed consent and participate in the study voluntarily.
- •3.Patients who have been undergoing treatment for Type 2 diabetes mellitus for at least six months.
- •4.Patients who are willing to undergo regular blood tests to monitor their HbA1c levels and other relevant biomarkers.
- •5.Patients who are willing to wear sleep monitoring devices to assess their sleep quality.
- •6.Patients who are able to attend regular follow up visits as part of the study protocol.
排除标准
- •1.Patients who have a history of sleep disorders other than poor sleep quality, such as sleep apnea or narcolepsy.
- •2.Patients who have a history of psychiatric disorders that may affect sleep quality or glycemic control, such as major depression or anxiety disorders.
- •3.Patients who have a history of substance abuse or dependence, including alcohol, opioids, or other drugs 4.Patients who are currently undergoing treatment with medications that may affect sleep quality or glycemic control, such as corticosteroids or beta-blockers.
- •5.Patients who have any significant medical conditions other than diabetes mellitus, such as cancer or chronic kidney disease, that may affect sleep quality or glycemic control.
- •6.Patients who are unable to comply with the study protocol or attend regular follow-up visits.
结局指标
主要结局
To explore the relationship between sleep quality (measured with Actigraphy) and glycemic control (measured in terms of glycated haemoglobin) in patients with type 2 diabetes mellitus
时间窗: Baseline, after 1 week and 3 months
次要结局
- To identify any factors that may confound or modify the relationship between sleep quality & glycemic control, such as age, gender, & body mass index (BMI), & body fat%(Baseline)
研究者
Ayesha Juhi
All India Institute Of Medical Sciences, Deoghar