低碳水化合物饮食治疗 2 型糖尿病（LoCaT）：一项多中心、随机对照试验的研究方案。

Low-carbohydrate diet in the treatment of type 2 diabetes mellitus (LoCaT): study protocol for a multicenter, randomized controlled trial.

机构信息

Department of Endocrinology and Metabolism, Shanghai Sixth People's Hospital Affiliated to Shanghai Jiao Tong University School of Medicine, Shanghai Clinical Center for Diabetes, Shanghai Diabetes Institute, Shanghai Key Laboratory of Diabetes Mellitus, 600 Yishan Rd, Shanghai, 200233, China.

Department of Endocrinology and Metabolism, Ningbo First Hospital, 59 Liuting Street, Ningbo, 315000, Zhejiang Province, China.

出版信息

Trials. 2023 Jun 19;24(1):411. doi: 10.1186/s13063-023-07427-5.

DOI:10.1186/s13063-023-07427-5

PMID:37337229

原文链接:https://pmc.ncbi.nlm.nih.gov/articles/PMC10278275/

Abstract

BACKGROUND

Low-carbohydrate diet (LCD) is an emerging therapy for type 2 diabetes mellitus (T2DM). Although its effect on glucose control has been confirmed in previous clinical trials, most of those studies have focused on comparing calorie-restricted LCD to iso-caloric low-fat diets. In this study, we aim to compare the effects of LCD and canagliflozin, a sodium-glucose cotransporter 2 inhibitor, in patients with T2DM.

METHODS

This is a multicenter, randomized controlled trial. We will recruit 120 patients with poor-controlled T2DM. Participants will be randomly divided into canagliflozin and LCD groups in a 1:1 ratio. The primary outcome is the change in hemoglobin A1C levels after the 3-month intervention. The secondary outcomes are the time in range and cost of antihyperglycemic agents. Exploratory outcomes include physical examination, body composition, glucose variability, appetite, glycolipid metabolism, liver lipid content, and urine glucose threshold.

DISCUSSION

No previous study has compared an LCD with antihyperglycemic agents. In LoCaT, participants' metabolism will be assessed from multiple perspectives. It is believed that the finding obtained from this trial will optimize the treatments for patients with T2DM.

TRIAL REGISTRATION

Chinese Clinical Trial Registry ChiCTR1900027592. Registered on November 20, 2019.

摘要

背景

低碳水化合物饮食（LCD）是治疗 2 型糖尿病（T2DM）的一种新兴疗法。尽管之前的临床试验已经证实了它对血糖控制的影响，但这些研究大多集中在比较热量限制的 LCD 与等热量低脂饮食。在这项研究中，我们旨在比较 LCD 和卡格列净（一种钠-葡萄糖协同转运蛋白 2 抑制剂）在 T2DM 患者中的疗效。

方法

这是一项多中心、随机对照试验。我们将招募 120 名血糖控制不佳的 T2DM 患者。参与者将以 1:1 的比例随机分为卡格列净组和 LCD 组。主要结局是干预 3 个月后糖化血红蛋白水平的变化。次要结局是血糖达标时间和抗高血糖药物的成本。探索性结局包括体格检查、身体成分、血糖变异性、食欲、糖脂代谢、肝脂质含量和尿糖阈值。