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临床试验/NCT07318727
NCT07318727招募中不适用

Three-Way Diet Comparison for Weight Loss in Overweight Endometrial Cancer Patients on Fertility-Sparing Regimens: A Randomized Controlled Trial

Peking University People's Hospital1 个研究点 分布在 1 个国家目标入组 81 人开始时间: 2025年1月10日最近更新:

试验速览

阶段
不适用
状态
招募中
入组人数
81
试验地点
1
主要终点
Body Mass Index(BMI)

研究概览

简要总结

In this study, overweight and obese patients with endometrial cancer treated with fertility- sparing therapy were randomly divided into three groups. The first group was given Intermittent fasting, the second was given Low-energy balanced diet, the third group underwent routine care for self-weight management. Relevant information such as body morphology ,glycolipid metabolism and tumor outcomes of the subjects were collected. By evaluating the tumor outcome and changes in glycolipid metabolism indicators, to confirm the effectiveness and safety of diet interventions for overweight and obese patients with endometrial cancer and treatd with fertility preservation.

详细描述

Obesity is recognized as a major risk factor for the development of endometrial cancer. Notably, several retrospective studies have shown that obesity reduces complete remission and pregnancy rates and increases recurrence rates in patients with endometrial cancer and atypical hyperplasia who undergo fertility-sparing treatment. Guidelines or consensus statements for fertility sparing treatment in endometrial cancer recommend weight management.The more accepted weight control diet programs mainly include calorie restriction and dietary changes. In dietary management, studies have shown that intermittent fasting ,low-energy balanced diet can improve patient outcomes. This study therefore aimed to investigate the impact of the different dietary interventions on body morphology and composition, glycolipid metabolism, and tumor outcomes in overweight and obese patients with endometrial cancer and atypical hyperplasia who underwent reproductive function-preserving treatments.In this study, overweight and obese patients with endometrial cancer treated with fertility- sparing therapy were randomly divided into second groups. The first group was given Intermittent fasting, the second was given Low-energy balanced diet, the third group underwent routine care for self-weight management.Relevant information such as body morphology ,glycolipid metabolism, molecular typing and tumor outcomes of the subjects were collected. By evaluating the tumor outcome and changes in glycolipid metabolism indicators, to confirm the effectiveness and safety of different dietary interventions management for overweight and obese patients with endometrial cancer and treatd with fertility preservation.

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
18 Years 至 40 Years(Adult)
性别
Female
接受健康志愿者

入选标准

  • age ≥18 years old
  • diagnosed as endometrial cancer or atypical hyperplasia
  • fertility-preserving therapy
  • BMI≥25 kg/m2
  • informed consent.

排除标准

  • those with communication barriers
  • pregnant women
  • medical and surgical serious complications: urinary calculi, history of renal failure or severe renal insufficiency, familial dyslipidemia, severe liver disease, chronic metabolic acidosis, history of pancreatitis, severe diabetes mellitus, active gallbladder disease, fat dyspepsia, severe cardiovascular and cerebrovascular diseases.

结局指标

主要结局

Body Mass Index(BMI)

时间窗: Baseline /Month 6 of intervention / Month 12 of intervention

Use the Inbody720 to measure height and weight and calculate BMI according to the formula"BMI (= weight (kg)/height2 (m2)

次要结局

  • A Body Shape Index(ABSI)(Baseline /Month 6 of intervention / Month 12 of intervention)
  • Complete Pathological Remission of Endometrial Cancer Tumor(Baseline /Month 6 of intervention / Month 12 of intervention)
  • Waist-to-height Ratio(WHtR)(Baseline /Month 6 of intervention / Month 12 of intervention)
  • Waist-to-hip Ratio(WHR)(Baseline /Month 6 of intervention / Month 12 of intervention)
  • Hip circumference(Baseline /Month 6 of intervention / Month 12 of intervention)
  • Body Roundness Index(BRI)(Baseline /Month 6 of intervention / Month 12 of intervention)
  • Fasting glucose(Baseline /Month 6 of intervention / Month 12 of intervention)
  • Waist circumference(Baseline /Month 6 of intervention / Month 12 of intervention)
  • Low density lipoprotein(Baseline /Month 6 of intervention / Month 12 of intervention)
  • Triglycerides(Baseline /Month 6 of intervention / Month 12 of intervention)
  • Glycated hemoglobin(Baseline /Month 6 of intervention / Month 12 of intervention)
  • Cholesterol(Baseline /Month 6 of intervention / Month 12 of intervention)
  • High density lipoprotein(HDL)(Baseline /Month 6 of intervention / Month 12 of intervention)
  • Fasting insulin(Baseline /Month 6 of intervention / Month 12 of intervention)

研究者

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

Xiaodan Li

Director

Peking University People's Hospital

研究点 (1)

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