1987年至2022年2型糖尿病随机安慰剂对照试验中基线糖化血红蛋白和体重指数的趋势：一项系统评价和荟萃分析

Trends in baseline HbA1c and body-mass index in randomised placebo-controlled trials of type 2 diabetes from 1987 to 2022: a systematic review and meta-analysis.

作者信息

Hu Suiyuan, Lin Chu, Cai Xiaoling, Li Zonglin, Lv Fang, Yang Wenjia, Ji Linong

机构信息

Department of Endocrinology and Metabolism, Peking University People's Hospital, Beijing, China.

出版信息

EClinicalMedicine. 2023 Feb 16;57:101868. doi: 10.1016/j.eclinm.2023.101868. eCollection 2023 Mar.

DOI:10.1016/j.eclinm.2023.101868

PMID:36864984

原文链接:https://pmc.ncbi.nlm.nih.gov/articles/PMC9971277/

Abstract

BACKGROUND

Curbing or reversing high glycated hemoglobin (HbA1c) and body mass index (BMI) are two essential parts in the clinical management of type 2 diabetes (T2D). We delineated the changing patterns of the baseline HbA1c and BMI in patients with T2D from placebo-controlled randomised trials to reflect the unmet clinical needs.

METHODS

PubMed, Medline, Embase and Cochrane Central Register of Controlled Trials (CENTRAL) databases were searched from inception to December 19, 2022. Placebo-controlled trials of T2D with reports of baseline HbA1c and BMI were included, of which summary data from published reports were extracted. Pooled effect sizes of baseline HbA1c and BMI of from studies published in the same year were computed in Random-effects model due to the high level of heterogeneity among studies. The main outcome was correlations between the pooled baseline HbA1c, the pooled baseline BMI, and study years. This study was registered in PROSPERO as CRD42022350482.

FINDINGS

We identified 6102 studies, of which 427 placebo-controlled trials with 261, 462 participants were finally included in the study. Baseline HbA1c level declined with time (Rs = -0.665, P ＜ 0.0001, I = 99.4%). Baseline BMI increased over the past 35 years (R = 0.464, P = 0.0074, I = 99.4%), rising by around 0.70 kg/m per decade. Patients with BMI ≤25.0 kg/m dropped substantially from the half in 1996 to none in 2022. Patients with BMI ranging from 25 kg/m to 30 kg/m stabilized at 30-40% since 2000.

INTERPRETATION

A substantial decline in baseline HbA1c levels and a constant increase in baseline BMI levels was found in placebo-controlled trials through the past 35 years, which indicated the improvement in glycemic control and the urgency for the management of obesity in T2D.

FUNDING

National Natural Science Foundation of China (No.81970698), Beijing Natural Science Foundation (No.7202216) and National Natural Science Foundation of China (No.81970708).

摘要

背景

控制或逆转高糖化血红蛋白（HbA1c）和体重指数（BMI）是2型糖尿病（T2D）临床管理的两个重要方面。我们通过安慰剂对照随机试验描绘了T2D患者基线HbA1c和BMI的变化模式，以反映未满足的临床需求。

方法

检索了PubMed、Medline、Embase和Cochrane对照试验中央注册库（CENTRAL）数据库，检索时间从建库至2022年12月19日。纳入报告了基线HbA1c和BMI的T2D安慰剂对照试验，并从已发表报告中提取汇总数据。由于研究间异质性水平较高，采用随机效应模型计算同年发表研究的基线HbA1c和BMI的合并效应量。主要结局是合并基线HbA1c、合并基线BMI与研究年份之间的相关性。本研究已在国际前瞻性注册系统（PROSPERO）注册，注册号为CRD42022350482。

结果

我们识别出6102项研究，其中427项安慰剂对照试验、共261462名参与者最终纳入本研究。基线HbA1c水平随时间下降（Rs = -0.665，P ＜ 0.0001，I² = 99.4%）。在过去35年中，基线BMI有所增加（R = 0.464，P = 0.0074，I² = 99.4%），每十年上升约0.70 kg/m²。BMI≤25.0 kg/m²的患者比例从1996年的一半大幅下降至2022年的零。自2000年以来，BMI在25 kg/m²至30 kg/m²之间的患者比例稳定在30%-40%。