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临床试验/NCT07139275
NCT07139275尚未招募不适用

Insulin Sensitivity and Testosterone Response to Aerobic Exercise Versus Added Sugar Elimination in Polycystic Ovary Syndrome Women

Cairo University0 个研究点目标入组 60 人开始时间: 2025年8月20日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
尚未招募
入组人数
60
主要终点
HOMA- IR (homeostatic model assesment of insulin resistance)

研究概览

简要总结

the aim of this study is to investigate the effect of aerobic exercise versus the effect of added sugar elimination on the insulin sensitivity and testosterone levels in females with polycystic ovarian syndrome via measuring the level of 6 hours fasting HOMA-IR and free testosterone before and after 3 months from starting the protocol. All patients were diagnosed as polycystic ovary syndrome with low insulin sensitivity levels

详细描述

In polycystic ovary syndrome the hyperandrogenic environment, in turn, promotes post-pubertal neuroendocrine dysfunction, which impairs the gonadotropin-releasing hormone (GnRH) pulse generator. This impairment leads to increased luteinizing hormone (LH) release and decreased follicle-stimulating hormone (FSH) release. These neuroendocrine unbalances support the progression to polycystic ovary syndrome, further enhancing hyperandrogenemia and ovulatory dysfunction .It is noteworthy to emphasize that IR in does not directly affect ovarian tissue. However, insulin can act as a co-gonadotropin through indirect mechanisms by enhancing luteinizing hormone (LH) action on theca cells. Additionally, insulin acts directly by inducing higher hypothalamic secretion of LH, resulting in increased production of dehydroepiandrosterone (DHEA) and androstenedione. insulin has a pleiotropic action and plays a key role not only in the regulation of metabolic homeostasis, but also in the ion and amino acid transport, in the cell proliferation, differentiation, and death, in the vascular function and inflammation, and in the neuro-hormonal activation. Abnormalities of insulin signaling transduction account for the development of insulin resistance which plays a mechanistic role in the pathogenesis of several cardiovascular risk factors such as diabetes, metabolic syndrome, hypertension, atherosclerosis, obesity, and non-alcoholic fatty liver disease (NAFLD). In addition, insulin resistance accounts also for the enhanced cardiovascular risk, and has been identified as an independent factor for the incidence of cardiovascular diseases including coronary artery disease, heart failure, and stroke. Moreover, insulin resistance negatively affects the clinical outcomes of cardiovascular and cerebrovascular diseases.

Over consuming sugar leads to fat cells that are less sensitive to the effects of insulin, which drives visceral adiposity and is a major contributor to hypertension, type 2 diabetes and heart diseases.

There is a consistent evidence that exercise training improves the baroreflex control of the sympathetic nervous system and reduces the sympathetic activity On the basis that There is a close relationship between the sympathetic nervous system and insulin sensitivity as Dysregulation of the sympathetic nervous system contributes to development of insulin resistance while Insulin stimulation increases the sympathetic nervous system activity by affecting the baroreflex sensitivity

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
Double (Participant, Investigator)

入排标准

年龄范围
25 Years 至 40 Years(Adult)
性别
Female
接受健康志愿者
是

入选标准

  • •sedentary overweight or obese females aged 25-40 years old with polycystic ovarian syndrome with low insulin sensitivity levels with a body mass index of 26-40 and all were diagnosed as having high, normal, or mildly elevated levels of homeostatic model assessment for insulin resistance and had none of the

排除标准

  • •could be included in this study.
  • •Exclusion Criteria: patients with orthopaedic disorders that could impede the ability to walk or exercise, cardiac diseases that could interfere with their ability to exercise

研究组 & 干预措施

Aerobic exercise (group I)

Experimental

20 patients performed a programme of aerobic exercise 3-5 days/ week

干预措施: aerobic exercise (Other)

added sugar elimination (group II)

Experimental

20 patients performed a programme of added sugar elimination

干预措施: added sugar elimination (Behavioral)

Aerobic exercise and added sugar elimination (group III)

Experimental

20 patients performed a programme of aerobic exercise and added sugar elimination

干预措施: aerobic exercise and added sugar elimination (Combination Product)

结局指标

主要结局

HOMA- IR (homeostatic model assesment of insulin resistance)

时间窗: test applied before and after 3 months of the interventions

a laboratory test for assessing the level of insulin sensitivity

free testosterone

时间窗: before and after 3 months from the beginning of the intervention protocol

a laboratory test that give information about the level of insulin sensitivity

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

Zainab Saeed Aly

principal investigator

Cairo University

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