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临床试验/NCT06588088
NCT06588088已完成不适用

Cardiorenal, Metabolic and Circadian Effects of Nighttime Eating

Koc University Hospital2 个研究点 分布在 1 个国家目标入组 16 人开始时间: 2022年5月1日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
16
试验地点
2
主要终点
Change of the concentration albuminuria in the Nighttime Eating Period

研究概览

简要总结

In this study, the investigators are trying to find out of the effect of nighttime eating on metabolism, cardiorenal, hormonal and circadian rhythm, and a study was conducted to examine the effects of diseases that are quite common in internal medicine practice, such as type 2 diabetes mellitus, chronic kidney disease, hypertension, metabolic syndrome and sleep disorders.

详细描述

The Coronavirus Disease (COVID)-19 pandemic, which emerged in recent years, has deeply affected living conditions and has had an impact on societies on eating habits. As shown by some studies, it has been shown that night sleep habits have changed and night nutrition and calorie intake have increased due to reasons related to staying at home, working remotely, and isolation during the pandemic period. However, some recent studies have shown a relationship between nighttime eating and conditions that predispose to metabolic syndrome, such as obesity and hyperglycemia. At the same time, prospective studies on the details of the cardiorenal and metabolic effects of night feeding behavior, which is one of the important predisposing factors for metabolic syndrome, are quite insufficient. Although the importance of nighttime eating habits has begun to be emphasized in recent years with recent randomized cross-controlled studies on this subject, there are not yet enough prospective studies on this subject. In this respect, studies on nighttime eating behavior, which is common in society, are important.In this study, a cross-over design study was conducted on the effectiveness of nighttime eating on metabolism, cardiorenal, hormonal and circadian rhythm, and a study was conducted to examine the effects of diseases that are quite common in internal medicine practice, such as type 2 diabetes mellitus, chronic kidney disease, hypertension, metabolic syndrome and sleep disorders. The investigators aim to create a new and additional perspective on the management, treatment and follow-up of common diseases and to contribute to raising awareness about night nutrition.

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
Health Services Research
盲法
None

入排标准

年龄范围
18 Years 至 65 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Being between the ages of 18-65
  • Being willing to adapt to the desired feeding time and calories
  • Body mass index (BMI) is between 18-30
  • Not having any systemic disease, not using chronic medication

排除标准

  • -<18, >65 years old
  • Failure to comply with the regulated nutrition program
  • BMI between <18 and >30
  • Presence of systemic disease: E.g. Diabetes Mellitus, Chronic Kidney Disease, Coronary Artery Disease, Hypertension etc.
  • Inability to have polygraphy
  • Chronic drug use

结局指标

主要结局

Change of the concentration albuminuria in the Nighttime Eating Period

时间窗: 1 week

More than 20% increase during night feeding period

Change of the concentration of serum melatonin levels in the Nighttime Eating Period

时间窗: 1 week

More than 50% increase during night feeding period

Change of the concentration of serum leptin levels in the Nighttime Eating Period

时间窗: 1 week

More than 50% increase during night feeding period

Change of the Concentration of serum ghrelin Levels in the Nighttime Eating Period

时间窗: 1 week

More than 50% increase during night feeding period

Change of the concentration of serum total cholesterol, low-density lipoprotein cholesterol, high density lipoprotein cholesterol and triglyceride levels in the Nighttime Eating Period

时间窗: 1 week

More than 20% increase during night feeding period

Change of Concentration of serum glucose in the Nighttime Eating Period

时间窗: 1 week

More than 10% increase during night feeding period

Change of Concentration of serum insulin in the Nighttime Eating Period

时间窗: 1 week

More than 10% increase during night feeding period

Change of concentration of serum Cortisol Level in the Nighttime Eating Period

时间窗: 1 week

More than 50% increase during night feeding period

Change of concentration of serum Fibroblast Growth Factor 21 Level in the Nighttime Eating Period

时间窗: 1 week

More than 10% increase during night feeding period

Change of the concentration of serum Cytokeratin 18 level in the Nighttime Eating Period

时间窗: 1 week

More than 10% increase during night feeding period

Change of value of Apnea Hypopnea Index in the Nighttime Eating Period

时间窗: 1 week

The Apnea-Hypopnea Index (AHI) is an index used to indicate the severity of sleep apnea. It is represented by the number of apnea and hypopnea events per hour of sleep. Apneas (pauses in breathing) must last for at least 10 seconds and be associated with a decrease in blood oxygenation to be considered. Combining AHI and oxygen desaturation gives an overall sleep apnea severity score that evaluates both the number of sleep breathing disruptions and the degree of oxygen desaturation (low oxygen level in the blood) during said disruptions. The AHI is calculated by dividing the number of apnea events by the number of hours of sleep. The AHI values for adults are categorized as: Normal: AHI\<5 Mild sleep apnea: 5≤AHI\<15 Moderate sleep apnea: 15≤AHI\<30 Severe sleep apnea: AHI≥30More than 10% increase during night feeding period

次要结局

未报告次要终点

研究者

发起方
Koc University Hospital
申办方类型
Other
责任方
Principal Investigator
主要研究者

Yavuz Erkam Kesgin

Medical Doctor, Resident in Internal Medicine

Koc University Hospital

研究点 (2)

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