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临床试验/NCT06805526
NCT06805526已完成不适用

Does Intermittent Islamic Fasting Have Beneficial Effect in Management of Metabolic Syndrome? a Randomized Control Trial

Zagazig University2 个研究点 分布在 1 个国家目标入组 54 人开始时间: 2023年8月1日最近更新:

试验速览

阶段
不适用
状态
已完成
入组人数
54
试验地点
2
主要终点
Changes in Body weight

研究概览

简要总结

Metabolic syndrome doubles the risk of developing cardiovascular diseases and type 2 diabetes mellitus. Intermittent Islamic fasting is an effective health strategy associated with various benefits. Objectives: to compare effect of Intermittent Islamic fasting with lifestyle modification versus lifestyle modification only on weight management, blood pressure, blood glucose and lipid profile among a group of metabolic syndrome patients.

详细描述

Metabolic Syndrome (MetS), also called "Syndrome X" or "insulin resistance syndrome," describes a common condition characterized by high blood pressure, elevated triglycerides, central obesity, and low HDL cholesterol levels . Having metabolic syndrome doubles the risk of developing cardiovascular diseases and type 2 diabetes mellitus. The prevalence of Metabolic Syndrome (MetS) is globally increasing due to the widespread adoption of the Western lifestyle . Between 2011 and 2018, the prevalence of Metabolic Syndrome (MetS) in the USA significantly increased from 37.6% in 2011-2012 to 41.8% in 2017-2018. This trend may be indicative of the rising epidemic of type 2 diabetes there . In Egypt, an estimated 10.9 million people currently have diabetes. This number is projected to rise to 13 million by 2030 and to 20 million by 2045.our aim to compare effect of Intermittent Islamic fasting with lifestyle modification versus lifestyle modification only on weight management, blood pressure, blood glucose and lipid profile among a group of metabolic syndrome patients.

A Randomized control open label trial was conducted on with metabolic syndrome, their ages range from (30- 45 years) attending the clinical nutrition outpatient clinic in the Zagazig University hospital from 1st of August (2023) to the end of February (2024) using consort guidelines and flow chart were used in this study including 54 patients with metabolic syndrome. At first, a Sample was picked by systematic random technique from patients attending clinical nutrition outpatient clinic of Zagazig University hospital then by block randomization, according to sex and BMI, the sample was classified randomly according to intervention type by block randomization using sealed Envelope website into 6 blocks each block size 9 list length with allocation ratio 1:1, Study was open -label . The sample was divided into two groups (intervention group and control group).

  1. Group I: intervention group (27 patients) followed Islamic fasting with lifestyle modification; (Islamic fasting means: fasting two days per week (Monday and Thursday) with fasting (13, 14, 15) middle of lunar months).
  2. Group II: control group (27 patients) followed lifestyle modification only.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Supportive Care
盲法
None

盲法说明

None (open label)

入排标准

年龄范围
30 Years 至 45 Years(Adult)
性别
All
接受健康志愿者

入选标准

  • Adults with metabolic syndrome
  • Adults (30-45years old)
  • providing a consent.

排除标准

  • Had any chronic diseases
  • pregnant females.

结局指标

主要结局

Changes in Body weight

时间窗: 6 months

Pre and Post measurements of body weight in kilograms

Change in waist circumference

时间窗: 6 months

Pre and Post measurements of waist circumference in centimeters

Changes in Body mass index

时间窗: 6 months

Pre and Post measurements of Body mass index in kg/m\^2

Changes in blood pressure

时间窗: 6 months

Periodic measurements in systolic and diastolic blood pressure in mmHg

次要结局

  • Lipid profile Assessment(6 months)
  • Fasting blood glucose level(6 months)

研究者

申办方类型
Other Gov
责任方
Principal Investigator
主要研究者

Hanaa Abu Elazayem Ibrahim Nofal

Principal Investigator

Zagazig University

研究点 (2)

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