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临床试验/NCT06882291
NCT06882291已完成不适用

Intermittent Fasting Diet Versus Resistive Exercise Program on Insulin Resistance in Obese Women With P.C.O.S

Cairo University1 个研究点 分布在 1 个国家目标入组 72 人开始时间: 2025年3月20日最近更新:
适应症
干预措施
相关药物

试验速览

阶段
不适用
状态
已完成
入组人数
72
试验地点
1
主要终点
HOM-IR calculation

研究概览

简要总结

This study will be carried out in an attempt to know which is more effective, Intermittent fasting diet or resistive exercise program on insulin resistance in obese woman with polycystic ovarian syndrome.

详细描述

Polycystic ovarian syndrome (PCOS) significantly impacts women, since the broad spectrum of clinical manifestations associated with it are significant and include reproductive dysfunction, menstrual irregularities, and an increased risk of infertility. However, the consequences of PCOS go beyond the reproductive axis, with psychological and social impairments, including stress, depression, anxiety and sexual dissatisfaction. There is also a high prevalence of dyslipidemia, hyperinsulinemia, obesity, hypertension, and glucose intolerance which are risk factors that predispose women to cardiovascular disease (CVD) and diabetes mellitus type 2 (DM2).

Improving Insulin resistance and excess adiposity are therefore key targets in PCOS management. International Evidence Based Guideline for the Assessment and Management of PCOS , highlights lifestyle intervention as the primary early management strategy. Lifestyle interventions are traditionally defined as those designed to improve dietary intake or physical activity through appropriate behavioural support. Time restricted eating (TRF), where patients are asked to consume all energy within a restricted daily time period, appears to offer more sustainable weight loss and cardiometabolic changes and may be more acceptable as a permanent lifestyle change.

Eight hour TRF may have beneficial effects on improving menstruation, hyperandrogenemia and reducing weight especially body fat, decreasing insulin resistance and chronic inflammation in women with anovulatory PCOS. TRF may be suitable for PCOS women with appropriate counseling and patient management.

The progressive resistance training (PRT) improved hyperandrogenism and the menstrual cycle as well as the functional capacity with increased muscle strength and resulted in changes in body composition with increased lean muscle mass and decreased central obesity without a reduced total weight. There were also improvements in quality of life and sexual function as complementary benefits.

So, This study will be carried out in an attempt to know Which is more effective, Intermittent fasting diet or resistive exercise program on insulin resistance in obese woman with polycystic ovarian syndrome.

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
Single (Outcomes Assessor)

入排标准

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

入选标准

  • •Seventy two obese women diagnosed with Polycystic ovarian syndrome by the gynecologist (based on the Rotterdam diagnostic criteria)
  • •Their age will range from 25 to 40 years old.
  • •Overweight or obese (BMI >25 kg/m2 and < 30 kg/m2).

排除标准

  • •The presence of diseases (such as congenital adrenal hyperplasia, Cushing syndrome, androgen secreting tumors, hyperprolactinemia, diabetes, thyroid diseases, Severe serious cardiovascular, gastrointestinal, kidney and liver diseases. premature ovarian failure, hypothalamic/pituitary disease
  • •Hormonal contraceptive use.
  • •Participants who did not complete the study were excluded from the analysis.
  • •Use of medication therapy that impacts carbohydrate or lipid metabolism (oral contraceptive pills, insulin sensitizers, anti epileptics, anti psychotics, statins, and fish oil) in the recent 6 months;
  • •Body weight fluctuations for more than 5% in the past 3 months; in preparation for pregnancy.
  • •Perimenopausal; night shift workers; fasting for more than 16 h per day; hypotension
  • •Alcohol intake for more than 100 g per week; smoking within the past 3 months
  • •Engaging in high intensity exercise.

研究组 & 干预措施

Intermittent fasting diet + medical treatment

Experimental

This group will consist of 24 obese PCOS women who will receive a program of Intermittent fasting diet for eight weeks and a medical treatment.

干预措施: Intermittent fasting diet (Other)

Intermittent fasting diet + medical treatment

Experimental

This group will consist of 24 obese PCOS women who will receive a program of Intermittent fasting diet for eight weeks and a medical treatment.

干预措施: Medical treatment (Drug)

Resistive exercise program + medical treatment

Experimental

This group will consist of 24 obese PCOS women who will receive a resistive exercise program for 30 minutes 5 times/week for eight weeks and a medical treatment.

干预措施: Resistive exercise program (Other)

Resistive exercise program + medical treatment

Experimental

This group will consist of 24 obese PCOS women who will receive a resistive exercise program for 30 minutes 5 times/week for eight weeks and a medical treatment.

干预措施: Medical treatment (Drug)

Medical treatment

Active Comparator

This group will consist of 24 obese PCOS women who will receive a medical treatment only.

干预措施: Medical treatment (Drug)

结局指标

主要结局

HOM-IR calculation

时间窗: 8 weeks

It is calculated from fasting glucose and fasting insulin. Different studies provide slightly different ranges for HOM-IR. But they all agree that the higher HOM-IR gets , the more insulin resistance are. Less than 1 : optimal insulin resistance. Above 1.9 : early insulin resistance. Above 2.9 : significant insulin resistance.

次要结局

  • Weight measurement(8 weeks)
  • Waist circumference measurement(8 weeks)
  • Waist/ hip ratio assessment(8 weeks)
  • Body mass index (BMI) measurement(8 weeks)
  • Body fat mass (BFM) measurement(8 weeks)
  • Skeletal muscle mass (SMM) measurement(8 weeks)

研究者

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

Wesam Samy Elsayed Elmokadem

Principal Investigator

Cairo University

研究点 (1)

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