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临床试验/NCT05126199
NCT05126199招募中不适用

The Effect of Time-restricted Eating on Insulin Levels and Other Metabolic Abnormalities in Polycystic Ovarian Syndrome: A Randomised Feasibility Study of Real-world Clinical Advice

Ruairí Floyd2 个研究点 分布在 1 个国家目标入组 20 人开始时间: 2021年5月5日最近更新:
适应症

试验速览

阶段
不适用
状态
招募中
发起方
入组人数
20
试验地点
2
主要终点
Drop-out rate

研究概览

简要总结

Polycystic ovarian syndrome (PCOS) is associated with metabolic symptoms such as hyperinsulinemia. Time-restricted eating may reduce serum insulin and improve insulin resistance in patients with PCOS. Currently, there are few studies investigating time-restricted eating in patients with PCOS. The investigators plan to test the feasibility of time-restricted eating in the management of PCOS by means of a real-world clinical intervention. The investigators will determine if an 18:6 eating protocol reduces insulin levels by means of a randomised controlled crossover trial.

详细描述

Background: Polycystic ovarian syndrome (PCOS) is the most common reproductive endocrinopathy in women of reproductive age with many associated metabolic symptoms, in particular hyperinsulinemia, insulin resistance and a high lifetime risk of type 2 diabetes mellitus. The effects of time-restricted eating on metabolic profiles have been investigated in many endocrinopathies, but there are minimal data in PCOS.

Methods: This study will investigate the feasibility of time-restricted eating in the management of PCOS, and its effects on insulin levels and other metabolic parameters.

To achieve this, the investigators will recruit 20 patients with PCOS (normal weight, overweight, obese).

In a randomised cross-over design, participants will be observed for two consecutive 12 week periods (with a 4 weeks washout period in between) following either 'time-restricted eating' or 'usual eating', detailed below.

  1. 18:6 protocol: 18 hours of fasting and a 6-hours eating window, with no other specific dietary advice. Participants choose their own 6-hour period according to their lifestyle and preference.
  2. Usual eating: follow usual eating patterns, no time restriction, no other dietary advice

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Crossover
主要目的
Treatment
盲法
Single (Outcomes Assessor)

入排标准

年龄范围
18 Years 至 42 Years(Adult)
性别
Female
接受健康志愿者

入选标准

  • Adult women of reproductive age with confirmed diagnosis of PCOS (Rotterdam Criteria, including at least 2 of 3 characteristics: oligomenorrhea, clinical and/or biochemical hyperandrogenism and ultrasound criteria)
  • No BMI restriction
  • Able and willing to provide explicit, informed consent

排除标准

  • Type 1 diabetes, medication-controlled type 2 diabetes
  • Pregnancy
  • Currently participating in weight loss programme, or reported weight change in last 3 months (>5% of current body weight)
  • Documented history of eating disorder
  • Ovulation medication, such as clomiphene citrate
  • Weight loss medication affecting weight or appetite in last 6 months, including weight loss medications, antipsychotic drugs or other medications as determine by the physician (eg. Semaglutide, liraglutide, orlistat, amphetamines, Qsymia (phentermine-topiramate), bupropion-naltrexone (Contrave))
  • Known liver, renal or thyroid dysfunction (not including non-alcoholic fatty liver disease with hypothyroidism on treatment or subclinical hypothyroidism seen in a large proportion of patients with PCOS)
  • Unable to participate in follow-up for at least 24 weeks
  • Unable or unwilling to provide explicit, informed consent

结局指标

主要结局

Drop-out rate

时间窗: 12 weeks

Assessing intervention feasibility

Adverse outcomes as assessed by CTCAE v4.0

时间窗: 12 weeks

Assessing intervention feasibility

Change in food diaries

时间窗: 12 weeks

Assessment of change of eating behaviours

Change in serum insulin

时间窗: 12 weeks

Measured with serum insulin levels to assess effects

次要结局

  • Change in insulin resistance(12 weeks)
  • Change in markers of hunger(12 weeks)
  • Change in testosterone levels(12 weeks)
  • Change in HbA1c(12 weeks)
  • Change in dehydroepiandrosterone sulfate (DHEA-S) levels(12 weeks)
  • Change in androstenedione levels(12 weeks)
  • Change in 17-Hydroxyprogesterone (17-OHP) levels(12 weeks)
  • Change in body weight(12 weeks)
  • Change in body mass index(12 weeks)
  • Change in dietary intake(12 weeks)
  • Change in free testosterone levels(12 weeks)
  • Change in sex hormone binding globulin (SHBG) levels(12 weeks)
  • Change in fasting glucose(12 weeks)
  • Change in anthropometric measurements (waist-hip ratio)(12 weeks)
  • Change in appetite(12 weeks)
  • Change in anthropometric measurements (waist circumference)(12 weeks)
  • Change in lipids(12 weeks)
  • Change in markers of satiety(12 weeks)

研究者

发起方
Ruairí Floyd
申办方类型
Other
责任方
Sponsor Investigator
主要研究者

Ruairí Floyd

Study Co-ordinator and Researcher

Tallaght University Hospital

研究点 (2)

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