Rasha Charrouf , Evelyn B. Parr , Amy T. Hutchison , Steve A. Flint , Xiao Tong Teong , Gary Wittert , Andrew D. Vincent , Leah Brennan , Brooke L. Devlin , John A. Hawley , Leonie K. Heilbronn
{"title":"限时进食与现行营养学实践对 2 型糖尿病高危人群血糖控制和心血管代谢结果的影响：多中心、平行分组、非劣效随机对照试验方案","authors":"Rasha Charrouf , Evelyn B. Parr , Amy T. Hutchison , Steve A. Flint , Xiao Tong Teong , Gary Wittert , Andrew D. Vincent , Leah Brennan , Brooke L. Devlin , John A. Hawley , Leonie K. Heilbronn","doi":"10.1016/j.cct.2024.107696","DOIUrl":null,"url":null,"abstract":"<div><h3>Background</h3><p>Time restricted eating (TRE) is a dietary strategy that may improve metabolic health. However, no studies have compared TRE with current practice (CP) in dietetics.</p></div><div><h3>Hypothesis</h3><p>TRE will not be inferior to CP to improve glycaemic control in individuals at risk of type 2 diabetes (T2D).</p></div><div><h3>Methods</h3><p>This parallel group, randomised, non-inferiority, controlled trial randomised 247 participants by site and glycated haemoglobin (HbA1c) into TRE or CP (1:1) for 12 months. Participants were aged 35–70 years, with a body mass index (BMI) >25 but <45 kg/m<sup>2</sup>, and score ≥15 on the Australian type 2 diabetes risk (AUSDRISK) assessment, without a diagnosis of T2D. Study visits were balanced between groups and all participants received five consultations at 0, 0.5, 1, 2 and 3 months. TRE followed a self-selected 9 h eating window (≥0600 and ≤1900), whereas CP followed Australian dietary guidelines.</p></div><div><h3>Outcomes</h3><p>The primary endpoint is the estimate of group mean difference (TRE vs CP) of HbA1c at 4 months in a covariate linear regression adjusting for stratification factors and sex. Secondary efficacy outcomes at 4 and 12 months are changes in fasting glucose, fasting insulin, HOMA-IR and nocturnal glucose by continuous glucose monitor incremental area under the curve and change in HbA1c at 12 months. Other endpoints are exploratory and will not be adjusted for multiplicity.</p></div><div><h3>Conclusions</h3><p>We will determine whether TRE is an alternate strategy to current practice in dietetics to improve glucose control.</p><p><strong>Trial registration:</strong> <span><span>NCT04762251</span><svg><path></path></svg></span>; 21 Feb 2021.</p></div>","PeriodicalId":10636,"journal":{"name":"Contemporary clinical trials","volume":"146 ","pages":"Article 107696"},"PeriodicalIF":2.0000,"publicationDate":"2024-09-17","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.sciencedirect.com/science/article/pii/S1551714424002799/pdfft?md5=acd72838f482adbb9b38430b3eb361a6&pid=1-s2.0-S1551714424002799-main.pdf","citationCount":"0","resultStr":"{\"title\":\"Effect of time restricted eating versus current practice in dietetics on glycaemic control and cardio-metabolic outcomes in individuals at risk of developing type 2 diabetes: Protocol for a multi-centre, parallel group, non-inferiority, randomised controlled trial\",\"authors\":\"Rasha Charrouf , Evelyn B. Parr , Amy T. Hutchison , Steve A. Flint , Xiao Tong Teong , Gary Wittert , Andrew D. Vincent , Leah Brennan , Brooke L. Devlin , John A. Hawley , Leonie K. Heilbronn\",\"doi\":\"10.1016/j.cct.2024.107696\",\"DOIUrl\":null,\"url\":null,\"abstract\":\"<div><h3>Background</h3><p>Time restricted eating (TRE) is a dietary strategy that may improve metabolic health. However, no studies have compared TRE with current practice (CP) in dietetics.</p></div><div><h3>Hypothesis</h3><p>TRE will not be inferior to CP to improve glycaemic control in individuals at risk of type 2 diabetes (T2D).</p></div><div><h3>Methods</h3><p>This parallel group, randomised, non-inferiority, controlled trial randomised 247 participants by site and glycated haemoglobin (HbA1c) into TRE or CP (1:1) for 12 months. Participants were aged 35–70 years, with a body mass index (BMI) >25 but <45 kg/m<sup>2</sup>, and score ≥15 on the Australian type 2 diabetes risk (AUSDRISK) assessment, without a diagnosis of T2D. Study visits were balanced between groups and all participants received five consultations at 0, 0.5, 1, 2 and 3 months. TRE followed a self-selected 9 h eating window (≥0600 and ≤1900), whereas CP followed Australian dietary guidelines.</p></div><div><h3>Outcomes</h3><p>The primary endpoint is the estimate of group mean difference (TRE vs CP) of HbA1c at 4 months in a covariate linear regression adjusting for stratification factors and sex. Secondary efficacy outcomes at 4 and 12 months are changes in fasting glucose, fasting insulin, HOMA-IR and nocturnal glucose by continuous glucose monitor incremental area under the curve and change in HbA1c at 12 months. 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Effect of time restricted eating versus current practice in dietetics on glycaemic control and cardio-metabolic outcomes in individuals at risk of developing type 2 diabetes: Protocol for a multi-centre, parallel group, non-inferiority, randomised controlled trial
Background
Time restricted eating (TRE) is a dietary strategy that may improve metabolic health. However, no studies have compared TRE with current practice (CP) in dietetics.
Hypothesis
TRE will not be inferior to CP to improve glycaemic control in individuals at risk of type 2 diabetes (T2D).
Methods
This parallel group, randomised, non-inferiority, controlled trial randomised 247 participants by site and glycated haemoglobin (HbA1c) into TRE or CP (1:1) for 12 months. Participants were aged 35–70 years, with a body mass index (BMI) >25 but <45 kg/m2, and score ≥15 on the Australian type 2 diabetes risk (AUSDRISK) assessment, without a diagnosis of T2D. Study visits were balanced between groups and all participants received five consultations at 0, 0.5, 1, 2 and 3 months. TRE followed a self-selected 9 h eating window (≥0600 and ≤1900), whereas CP followed Australian dietary guidelines.
Outcomes
The primary endpoint is the estimate of group mean difference (TRE vs CP) of HbA1c at 4 months in a covariate linear regression adjusting for stratification factors and sex. Secondary efficacy outcomes at 4 and 12 months are changes in fasting glucose, fasting insulin, HOMA-IR and nocturnal glucose by continuous glucose monitor incremental area under the curve and change in HbA1c at 12 months. Other endpoints are exploratory and will not be adjusted for multiplicity.
Conclusions
We will determine whether TRE is an alternate strategy to current practice in dietetics to improve glucose control.
期刊介绍：
Contemporary Clinical Trials is an international peer reviewed journal that publishes manuscripts pertaining to all aspects of clinical trials, including, but not limited to, design, conduct, analysis, regulation and ethics. Manuscripts submitted should appeal to a readership drawn from disciplines including medicine, biostatistics, epidemiology, computer science, management science, behavioural science, pharmaceutical science, and bioethics. Full-length papers and short communications not exceeding 1,500 words, as well as systemic reviews of clinical trials and methodologies will be published. Perspectives/commentaries on current issues and the impact of clinical trials on the practice of medicine and health policy are also welcome.
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