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临床试验/NCT04392570
NCT04392570已完成不适用

The Effect of Ramadan Fasting on Serum Osmolarity in Patients With Type 2 Diabetes

Istanbul Medeniyet University1 个研究点 分布在 1 个国家目标入组 52 人开始时间: 2019年5月15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
52
试验地点
1
主要终点
To compare the serum osmolarities of patients with type 2 diabetes who are fasting for 17 hours and who are not fasting.

研究概览

简要总结

In Ramadan, Muslims perform a special kind of fasting. Their fasting start with the first lights of the sunrise and end with the sunset. Especially in summer, it is a real challenge, as the time for fasting might be as long as 18 hours, and hot weather might cause severe dehydration. This might be dangerous, especially in patients with diabetes. Serum osmolarity is a good surrogate marker to evaluate the body's fluid content. We aimed to investigate if summertime Ramadan fasting causes further fluid loss in patients with type 2 diabetes.

详细描述

Till recently, it was assumed that patients with type 2 diabetes have to eat frequently, especially to avoid hypoglycemia, which is still true if they are using sulphonylurea or insulin. Especially because patients with diabetes often have one or more diabetic complications, they were advised against Ramadan fasting, as it is not allowed to eat or drink anything for long hours. There are increasing data supporting intermittent fasting, where individuals won't eat anything for 12-18 hours but are permitted to drink sugar-free beverages. The new antihypoglycemic agents have the advantage of causing very low or no hypoglycemia, which allows these patients to eat less frequently. There are studies about the metabolic effect of intermittent fasting in patients with type 2 diabetes, but we don't have enough data for the safety of religious fasting where no kind of fluid intake is allowed. In this study, we aimed to investigate the effect of fasting on the fluid status of diabetic patients. To this effect, we used serum osmolarity to determine fluid status. The patients who preferred to fast were our study group, and the patients who were healthy otherwise but preferred not to fast were our control group. In Ramadan, contrary to the customary practice of intermittent fasting, fasting starts with the sunrise and continues till sunset. We planned to take the first blood sample at 10 am and the second blood sample at 06 pm in both groups and compare the serum osmolarity accordingly.

研究设计

研究类型
Observational
观察模型
Case Control
时间视角
Prospective

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

  • patients with type 2 diabetes
  • will accept to give two different blood samples
  • will prefer to fast during Ramadan ( for the intervention group)
  • will prefer not to fast during Ramadan ( for the control group)
  • have good glycemic control

排除标准

  • if the patients are not eligible for fasting

结局指标

主要结局

To compare the serum osmolarities of patients with type 2 diabetes who are fasting for 17 hours and who are not fasting.

时间窗: 1 month

osmolarity is the measure of solute concentration. In our study we used it as a surrogate marker for fluid loss during fasting

次要结局

未报告次要终点

研究者

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

Mirac Vural Keskinler

Principal Investigator

Istanbul Medeniyet University

研究点 (1)

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