DRINK-T1D 研究的原理和设计：限制 1 型糖尿病儿童食用低卡路里甜味剂的随机临床试验。
Rationale and design of DRINK-T1D: A randomized clinical trial of effects of low-calorie sweetener restriction in children with type 1 diabetes.
机构信息
Department of Exercise and Nutrition Sciences, Milken Institute School of Public Health, The George Washington University, 950 New Hampshire Avenue NW, Suite 200, Washington, DC 20052, USA.
Division of Psychology & Behavioral Health, Children's National Hospital, 111 Michigan Avenue NW, Washington, DC 20010, USA.
出版信息
Contemp Clin Trials. 2021 Jul;106:106431. doi: 10.1016/j.cct.2021.106431. Epub 2021 May 8.
BACKGROUND
Low-calorie sweeteners (LCSs) provide sweetness without sugar or calories and are used to replace added sugars by many children with type 1 diabetes (T1D). However, the role of LCSs in diabetes management and cardiometabolic health is unclear.
OBJECTIVE
The Diabetes Research in Kids Study (DRINK-T1D) aims to investigate effects of LCS restriction on glycemic variability, visceral adiposity, lipid profiles, and systemic inflammation among children 6-12 years old with T1D.
METHODS
Children with T1D, who report habitual consumption of foods and beverages containing LCSs, are recruited from the Washington Nationals Diabetes Care Complex (DCC) at Children's National Hospital (CNH) in Washington, DC. Following a phone screening and two-week run-in period involving continuation of usual LCS intake, children are randomized to 12 weeks of LCS restriction (replacement of diet beverages with still or sparkling water and avoidance of other sources of LCSs) or continued usual LCS intake (control). The primary outcome is the difference in change in glycemic variability in the LCS restriction group versus the control group. Change in glycemic variability will be assessed as the difference in daily average time-in-range (TIR), measured using continuous glucose monitoring (CGM) during two weeks at the end of the 12-week intervention, compared with during the two-week run-in period prior to randomization. Participants also complete a variety of anthropometric, metabolic, dietary, and behavioral assessments throughout the 14-week study.
CONCLUSIONS
DRINK-T1D is an innovative, randomized controlled trial, evaluating effects of LCS restriction on glycemic variability and cardiometabolic health in children with T1D. Findings of DRINK-T1D will support or challenge the common practice of recommending LCS use in this patient population and will have clinically relevant implications for pediatric T1D management.
TRIAL REGISTRATION
ClinicalTrials.gov Identifier NCT04385888.
背景
低卡路里甜味剂（LCS）提供甜味而不含糖或卡路里，并被许多 1 型糖尿病（T1D）儿童用于替代添加的糖。然而，LCS 在糖尿病管理和心脏代谢健康中的作用尚不清楚。
目的
糖尿病儿童研究（DRINK-T1D）旨在研究限制 LCS 摄入对 6-12 岁 T1D 儿童血糖变异性、内脏脂肪、血脂谱和全身炎症的影响。
方法
在华盛顿特区华盛顿国家糖尿病护理综合体（DCC）从儿童国家医院（CNH）招募报告习惯性食用含 LCS 的食物和饮料的 T1D 儿童。在电话筛查和两周的适应期（继续摄入常规 LCS）后，将儿童随机分为 12 周的 LCS 限制组（用纯水或碳酸水替代饮食饮料，并避免其他 LCS 来源）或继续常规 LCS 摄入组（对照组）。主要结局是 LCS 限制组与对照组之间血糖变异性变化的差异。血糖变异性的变化将通过在 12 周干预结束时使用连续血糖监测（CGM）测量的两周内的每日平均时间在范围内（TIR）的差异来评估，与随机分组前两周的适应期相比。参与者还在 14 周的研究期间完成各种人体测量、代谢、饮食和行为评估。
结论
DRINK-T1D 是一项创新性的随机对照试验，评估限制 LCS 摄入对 T1D 儿童血糖变异性和心脏代谢健康的影响。DRINK-T1D 的研究结果将支持或挑战在该患者群体中推荐使用 LCS 的常见做法，并将对儿科 T1D 管理具有临床相关意义。
试验注册
ClinicalTrials.gov 标识符 NCT04385888。
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