ACTRN12620000453987已完成未知
A randomised controlled trial to compare time restricted eating with standard dietetic practices on glycaemic control in individuals with type 2 diabetes: a pilot study
Dr Evelyn Parr0 个研究点目标入组 52 人开始时间: 2020年4月8日最近更新:
试验速览
- 阶段
- 未知
- 状态
- 已完成
- 发起方
- 入组人数
- 52
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
- Randomised controlled trial
- 主要目的
- Treatment
- 盲法
- Blinded (masking 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% - 10%, 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
- •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);
- •Currently seeing or within 1 month of seeing a dietitian;
- •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.
研究者
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