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临床试验/NCT06976164
NCT06976164招募中不适用

The Effects of Reflexo Therapy of Sole on Gestational Diabetes Mellitus

Kafrelsheikh University1 个研究点 分布在 1 个国家目标入组 36 人开始时间: 2025年5月1日最近更新:

试验速览

阶段
不适用
状态
招募中
入组人数
36
试验地点
1
主要终点
Change in The Oral Glucose Tolerance Test.

研究概览

简要总结

The purpose of this study will be to detect the effects of Reflexo therapy of sole on GDM.

详细描述

Gestational diabetes mellitus is considered a hazard factor for antenatal complications for both mother and fetus. It is characterized by glucose intolerance of variable degrees with the beginning or first recognition of pregnancy. It affects 14% of pregnancies worldwide, and it undergoes continuous changes in the diagnostic criteria, ethnicity and the population studied.

There is an increasing prevalence of diabetes mellitus, and its major metabolic disorder caused by the insulin secretion defect or insulin action defect resulting from a defect in insulin secretion, insulin action, or both. As a result, it will lead to chronic hyperglycemia associated with carbohydrates, protein, and fat disturbance.

In spite of the fact that the reason for gestational diabetes mellitus is still not fully understood, it is proposed that human placental lactogen has growth hormone-like actions, and that it causes lipolysis and thus increases the levels of circulating fatty acids that repress the action of insulin and cause insulin resistance in pregnant females which appear to play a crucial role in the pathogenesis of gestational diabetes mellitus.

研究设计

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

入排标准

年龄范围
20 Years 至 35 Years(Adult)
性别
Female
接受健康志愿者

入选标准

  • They were maternally aged between 20 and 35 years.
  • The gestational age ranged from between 24 and 36 weeks.
  • Their BMI didn't exceed 30 kg/m
  • A singleton live fetus and not under stressful event.

排除标准

  • They had high-risk pregnancies.
  • Bad obstetric situations.
  • Diseases that could interfere with participation.
  • Oral sedative administration.

结局指标

主要结局

Change in The Oral Glucose Tolerance Test.

时间窗: Change from Baseline Oral Glucose Tolerance Test at one month

Change in The Hemoglobin A1C Test.

时间窗: Change from Baseline Hemoglobin A1C Test at one month

次要结局

未报告次要终点

研究者

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

Yomna Ghanem

Demonstrator

Kafrelsheikh University

研究点 (1)

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