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临床试验/ACTRN12618000938202
ACTRN12618000938202已完成未知

A time for food: The feasibility of time-restricted eating in individuals with type 2 diabetes and consequential effects on glycaemic control

Dr Evelyn Parr0 个研究点目标入组 24 人开始时间: 2018年6月4日最近更新:
适应症

试验速览

阶段
未知
状态
已完成
发起方
入组人数
24

研究概览

简要总结

暂无简介。

研究设计

研究类型
Interventional
分配方式
Non-randomised trial
主要目的
Treatment
盲法
Open (masking not used)

入排标准

年龄范围
35 Years 至 65 Years(—)
性别
All

入选标准

  • Aged 35 to 65 years old
  • Diagnosed (by a GP/endocrinologist) with type 2 diabetes mellitus (T2D), with an HbA1c between 6.5% - 9%, either with diet-controlled or taking up to two oral hypoglycaemic agents (excluding sulphonylureas)
  • Body mass index (BMI) between 25 - 45 kg/m2 (but total mass not >200 kg due to DXA measures)
  • Currently consuming energy (i.e. dietary intake) over a period of 12 h or more, habitually (i.e. self-reported on 5/7 days per week)

排除标准

  • Not a regular breakfast consumer;
  • Does not have a smart phone or cannot operate the camera function on a smart phone;
  • Taking more than 2 oral hypoglycaemic agents (OHAs), taking sulphonylrueas, or other glucose lowering medications (i.e. GLP-1 angonists, or insulin), or unstable use of OHA (i.e. not taking them for at least a 3 month period).
  • Currently following a strict diet (i.e. vegan, coeliac/gluten free, ketogenic);
  • Participate in regular fasting (defined as fasting for greater than or equal to 16 h/day or having completed twelve 24-h fasts within the past year);
  • Participating in shift work (i.e. >3 h between 10 pm and 5 am for 1 day per week (>50 days per year))
  • Not weight stable (>5 kg change over last 3 months);
  • On prescribed medications required to be taken with food in the early morning or late evening or taking other prescribed medications for <3 months;
  • Current smoker (tobacco, nicotine or marijuana) or within 3 months of quitting;
  • Women who are pregnant, breastfeeding (within 24 wk);
  • History of psychotic disorder, current diagnosis of other major psychiatric illness (e.g. mood disorder, eating disorder, substance use disorder; does not include depression)
  • Psychopharmacological treatment that has not been stable for more than 3 months;
  • Medications known to promote weight gain, weight loss or interact with glucose metabolism (i.e. corticosteroids);
  • Diagnosed gastrointestinal conditions, surgery (i.e. bariatric) or impaired nutrient absorption;
  • Antibiotic use in previous 3 months.

研究者

发起方
Dr Evelyn Parr

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