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Semaglutide 用于治疗既往妊娠糖尿病女性的葡萄糖不耐受 (SERENA)

2026年9月11日 更新者：Universitaire Ziekenhuizen KU Leuven

Semaglutide 用于治疗既往妊娠糖尿病女性的葡萄糖不耐受：一项双盲 RCT

妊娠糖尿病 (GDM) 是导致 2 型糖尿病 (T2DM) 患病率增加的重要因素。 产后早期糖耐量异常的女性是一个特别高危的人群，约 50% 的女性会在分娩后 5 年内发展为 T2DM。 此外，与血糖水平相似升高的女性相比，有 GDM 病史的女性进展为 T2DM 的速度更快。 因此，首次妊娠后的早期干预对于预防 T2DM 至关重要。 因此，通过 SERENA 项目，我们旨在使用长效 GLP-1 激动剂 semaglutide 降低近期有 GDM 病史和产后早期葡萄糖不耐受的女性患 T2DM 的风险。

研究概览

地位

招聘中

条件

干预/治疗

详细说明

患者人群：有妊娠糖尿病 (GDM) 近期病史和产后早期持续葡萄糖不耐受的女性是一个特别高的风险群体，约 50% 的女性在分娩后 5 年内发展为 2 型糖尿病 (T2DM)。 Semaglutide 是一种长效胰高血糖素样肽-1 (GLP-1) 激动剂，具有多种有益的代谢作用，包括降糖作用、减肥作用和心血管保护作用。 我们假设，对于既往患有 GDM 和产后早期葡萄糖不耐受的女性，与安慰剂相比，semaglutide 治疗将降低长期发展为 T2DM 的风险。

干预和比较：比利时 12 个中心的多中心双盲随机对照试验，比较 semaglutide（每周一次）与安慰剂在近期有 GDM 和葡萄糖不耐受 [空腹血糖受损 (IFG) 和/或葡萄糖耐量受损 (IGT) 病史的女性中的效果] 产后6-24周。 在生活方式测量的背景下，参与者将以 1/1 的比例随机分配至 semaglutide 或安慰剂。 Semaglutide 将在 8 周内增加至 1mg/周。 参与者将被随访 3 年。 参与者将在干预停止 3 个月后接受 75g 口服葡萄糖耐量试验 (OGTT)。 将根据产后早期访视时的 BMI 对随机化进行分层（

结果：主要终点是由 OGTT 和/或 HbA1c 定义的 T2DM 的发展。 重要的次要终点包括糖尿病抢救治疗的需要、血糖恢复正常、体重减轻、β细胞功能、胰岛素抵抗和代谢综合征。 为达到 80% 的功效，我们计划样本量为 206，以检测两组之间患 T2DM 的风险估计降低 50%，假设在研究期间有 30% 的失访。

研究类型

介入性

注册 (估计的)

252

阶段

  • 第三阶段

联系人和位置

本节提供了进行研究的人员的详细联系信息，以及有关进行该研究的地点的信息。

学习联系方式

学习地点

  • 比利时
      • Aalst、比利时
        • 招聘中
        • AZORG
        • 接触：
          • Katrien Wierckx
      • Antwerp、比利时
        • 招聘中
        • UZA
        • 接触：
          • Niels Bochanen
      • Antwerp、比利时
        • 招聘中
        • ZAS
        • 接触：
          • Ann Verhaegen
      • Bruges、比利时
      • Brussels、比利时
        • 招聘中
        • UZ Brussel
        • 接触：
          • Nancy Van Wilder
      • Brussels、比利时
        • 招聘中
        • Erasme
        • 接触：
          • Maria Lytrivi
      • Ieper、比利时
        • 招聘中
        • Jan Yperman
        • 接触：
      • Kortrijk、比利时
        • 招聘中
        • AZ Groeninge Kortrijk
        • 接触：
          • Gertjan Vereecke
      • Leuven、比利时
        • 招聘中
        • UZ Leuven
        • 接触：
          • Katrien Benhalima
      • Liège、比利时
        • 招聘中
        • CHU de Liege
        • 接触：
          • JC Philips
      • Mouscron、比利时
        • 招聘中
        • Centre Hospitalier Mouscron
        • 接触：
          • Philippe Oriot
      • Sint-Niklaas、比利时
        • 招聘中
        • Vitaz
        • 接触：
          • Peter Coremans
      • Turnhout、比利时

参与标准

研究人员寻找符合特定描述的人，称为资格标准。这些标准的一些例子是一个人的一般健康状况或先前的治疗。

资格标准

适合学习的年龄

18年 及以上 (成人、年长者)

接受健康志愿者

不

描述

纳入标准：

  1. 在任何筛选程序之前已获得参与者的自愿书面知情同意
  2. 使用高效的节育方法
  3. GDM 病史（根据 2013 年 WHO 标准在妊娠 24-32 周诊断）和产后 6-24 周葡萄糖不耐受（根据 ADA 标准）
  4. 需要能够理解和说荷兰语、法语或英语

排除标准：

  • 1.参与者有任何类型的糖尿病病史或1型糖尿病自身抗体、胰腺炎病史、甲状腺髓样癌或多发性内分泌肿瘤综合征2型家族或个人病史、过去一年有严重精神疾病、心力衰竭NYHA 4 级，终末期肾病 (eGFR

学习计划

本节提供研究计划的详细信息，包括研究的设计方式和研究的衡量标准。

研究是如何设计的？

设计细节

  • 主要用途：预防
  • 分配：随机化
  • 介入模型：并行分配
  • 屏蔽：三倍

武器和干预

参与者组/臂
干预/治疗
有源比较器：索马鲁肽
semaglutide SC 每周一次，在 2 个月内增加至 1mg/周（0.25mg 每周一次，4 周后 0.5mg 每周一次，8 周后维持剂量 1mg 每周一次），治疗持续时间最长。 3年
药品：Semaglutide笔式注射器
维持剂量 1mg SC 每周一次
其他名称：
  • 臭氧层
安慰剂比较：安慰剂
安慰剂 SC 每周一次，相同的剂量递增方案，使用匹配的注射，治疗持续时间最长。 3年
药品：索马鲁肽安慰剂
维持剂量 1mg SC 每周一次

研究衡量的是什么？

主要结果指标

结果测量
措施说明
大体时间
Development of T2DM
大体时间：by 160 weeks
Defined by FPG, OGTT, and/or HbA1c according to the ADA criteria
by 160 weeks

次要结果测量

结果测量
措施说明
大体时间
Need for glucose-lowering (rescue) therapy
大体时间：Assessed at 160 weeks (end of treatment) and at 172-184 weeks (3-6 months after discontinuation of study medication)
Percentage need for rescue therapy for diabetes
Assessed at 160 weeks (end of treatment) and at 172-184 weeks (3-6 months after discontinuation of study medication)
Frequency of prediabetes based on FPG, OGTT, and/or HbA1c
大体时间：Assessed at 160 weeks (end of treatment) and at 172-184 weeks (3-6 months after discontinuation of study medication)
Percentage of prediabetes based on FPG, OGTT, and/or HbA1c
Assessed at 160 weeks (end of treatment) and at 172-184 weeks (3-6 months after discontinuation of study medication)
Regression to normoglycaemia
大体时间：Assessed at 160 weeks (end of treatment) and at 172-184 weeks (3-6 months after discontinuation of study medication)
Percentage regression to normoglycaemia, based on fasting glycaemia, oral glucose tolerance test and/or HbA1c (ADA criteria)
Assessed at 160 weeks (end of treatment) and at 172-184 weeks (3-6 months after discontinuation of study medication)
Change in body weight
大体时间：Assessed at 160 weeks (end of treatment) and at 172-184 weeks (3-6 months after discontinuation of study medication)
Change in body weight (kg)
Assessed at 160 weeks (end of treatment) and at 172-184 weeks (3-6 months after discontinuation of study medication)
BMI
大体时间：Assessed at 160 weeks (end of treatment) and at 172-184 weeks (3-6 months after discontinuation of study medication)
Mean BMI (Kg/m2)
Assessed at 160 weeks (end of treatment) and at 172-184 weeks (3-6 months after discontinuation of study medication)
Waist circumference
大体时间：Assessed at 160 weeks (end of treatment) and at 172-184 weeks (3-6 months after discontinuation of study medication)
Mean waist circumference (cm)
Assessed at 160 weeks (end of treatment) and at 172-184 weeks (3-6 months after discontinuation of study medication)
Waist-to-hip ratio
大体时间：Assessed at 160 weeks (end of treatment) and at 172-184 weeks (3-6 months after discontinuation of study medication)
Waist/hip circumference ratio
Assessed at 160 weeks (end of treatment) and at 172-184 weeks (3-6 months after discontinuation of study medication)
Proportion of participants achieving ≥5% weight loss
大体时间：Assessed at 160 weeks (end of treatment) and at 172-184 weeks (3-6 months after discontinuation of study medication)
Percentage weight loss ≥5%
Assessed at 160 weeks (end of treatment) and at 172-184 weeks (3-6 months after discontinuation of study medication)
Proportion of participants achieving ≥10% weight loss
大体时间：Assessed at 160 weeks (end of treatment) and at 172-184 weeks (3-6 months after discontinuation of study medication)
Percentage weight loss ≥10%
Assessed at 160 weeks (end of treatment) and at 172-184 weeks (3-6 months after discontinuation of study medication)
Proportion of participants achieving ≥15% weight loss
大体时间：Assessed at 160 weeks (end of treatment) and at 172-184 weeks (3-6 months after discontinuation of study medication)
Percentage weight loss ≥15%
Assessed at 160 weeks (end of treatment) and at 172-184 weeks (3-6 months after discontinuation of study medication)
Body fat percentage assessed by bioelectrical impedance analysis (Bodystat 1500®)
大体时间：Assessed at 160 weeks (end of treatment) and at 172-184 weeks (3-6 months after discontinuation of study medication)
Percentage body fat measured by bioelectrical impedance analysis
Assessed at 160 weeks (end of treatment) and at 172-184 weeks (3-6 months after discontinuation of study medication)
β-cell function, assessed by HOMA-B
大体时间：Assessed at 160 weeks (end of treatment) and at 172-184 weeks (3-6 months after discontinuation of study medication)
Beta-cell function measured by the HOMA-B index
Assessed at 160 weeks (end of treatment) and at 172-184 weeks (3-6 months after discontinuation of study medication)
Insulinogenic index divided by HOMA-IR
大体时间：Assessed at 160 weeks (end of treatment) and at 172-184 weeks (3-6 months after discontinuation of study medication)
Beta-cell function measured by the by the insulinogenic index divided by HOMA-insulin resistance index
Assessed at 160 weeks (end of treatment) and at 172-184 weeks (3-6 months after discontinuation of study medication)
Insulin secretion-sensitivity index-2
大体时间：Assessed at 160 weeks (end of treatment) and at 172-184 weeks (3-6 months after discontinuation of study medication)
Beta-cell function measured by theby the insulin-secretion sensitivity-2 index
Assessed at 160 weeks (end of treatment) and at 172-184 weeks (3-6 months after discontinuation of study medication)
Stumvoll index
大体时间：Assessed at 160 weeks (end of treatment) and at 172-184 weeks (3-6 months after discontinuation of study medication)
Beta-cell function measured by the Stumvoll index
Assessed at 160 weeks (end of treatment) and at 172-184 weeks (3-6 months after discontinuation of study medication)
Insulin sensitivity, assessed by the Matsuda index (reflecting whole body insulin sensitivity)
大体时间：Assessed at 160 weeks (end of treatment) and at 172-184 weeks (3-6 months after discontinuation of study medication)
Whole body Insulin sensitivity measured by the insulin sensitivity index of Matsuda
Assessed at 160 weeks (end of treatment) and at 172-184 weeks (3-6 months after discontinuation of study medication)
1/HOMA-IR, reflecting primarily hepatic insulin sensitivity
大体时间：Assessed at 160 weeks (end of treatment) and at 172-184 weeks (3-6 months after discontinuation of study medication)
The reciprocal of the homeostasis model assessment of insulin resistance (1/HOMA-IR)
Assessed at 160 weeks (end of treatment) and at 172-184 weeks (3-6 months after discontinuation of study medication)
Prevalence of the metabolic syndrome
大体时间：Assessed at 160 weeks (end of treatment) and at 172-184 weeks (3-6 months after discontinuation of study medication)
Percentage of the metabolic syndrome based on the WHO criteria
Assessed at 160 weeks (end of treatment) and at 172-184 weeks (3-6 months after discontinuation of study medication)
Blood pressure (blood pressure ≥140/90 mmHg)
大体时间：Assessed at 160 weeks (end of treatment) and at 172-184 weeks (3-6 months after discontinuation of study medication)
Percentage blood pressure ≥140/90mmHg
Assessed at 160 weeks (end of treatment) and at 172-184 weeks (3-6 months after discontinuation of study medication)
Heart rate
大体时间：Assessed at 160 weeks (end of treatment) and at 172-184 weeks (3-6 months after discontinuation of study medication)
Mean heart rate
Assessed at 160 weeks (end of treatment) and at 172-184 weeks (3-6 months after discontinuation of study medication)
Lipid profile, including low density lipoprotein-cholesterol (LDL-cholesterol, ≥100 mg/dL or ≥2,6 mmol/L)
大体时间：Assessed at 160 weeks (end of treatment) and at 172-184 weeks (3-6 months after discontinuation of study medication)
Percentage LDL cholesterol ≥100mg/dl or ≥2,6 mmol/L
Assessed at 160 weeks (end of treatment) and at 172-184 weeks (3-6 months after discontinuation of study medication)
Lipid profile, including triglycerides (≥150 mg/dL or ≥1,7 mmol/L)
大体时间：Assessed at 160 weeks (end of treatment) and at 172-184 weeks (3-6 months after discontinuation of study medication)
Percentage triglycerides ≥150mg/dl or ≥1,7 mmol/L
Assessed at 160 weeks (end of treatment) and at 172-184 weeks (3-6 months after discontinuation of study medication)
Health-related quality of life assessed by SF-36
大体时间：Assessed at 160 weeks (end of treatment) and at 172-184 weeks (3-6 months after discontinuation of study medication)
Health-related quality of life assessed using the 36-Item Short Form Health Survey (SF-36). Scores range from 0 to 100, with higher scores indicating better health-related quality of life
Assessed at 160 weeks (end of treatment) and at 172-184 weeks (3-6 months after discontinuation of study medication)
Health-related quality of life assessed by EQ-5D-5L
大体时间：Assessed at 160 weeks (end of treatment) and at 172-184 weeks (3-6 months after discontinuation of study medication)
Health-related quality of life assessed using the EuroQol 5-Dimension 5-Level (EQ-5D-5L) Visual Analogue Scale (EQ VAS). Scores range from 0 to 100, with higher scores indicating better perceived health status
Assessed at 160 weeks (end of treatment) and at 172-184 weeks (3-6 months after discontinuation of study medication)
Symptoms of depression (CES-D)
大体时间：Assessed at 160 weeks (end of treatment) and at 172-184 weeks (3-6 months after discontinuation of study medication)
Depressive symptoms assessed using the 20-item Center for Epidemiologic Studies Depression Scale (CES-D). Total scores range from 0 to 60, with higher scores indicating more depressive symptoms
Assessed at 160 weeks (end of treatment) and at 172-184 weeks (3-6 months after discontinuation of study medication)
Symptoms of anxiety (short-form STAI)
大体时间：Assessed at 160 weeks (end of treatment) and at 172-184 weeks (3-6 months after discontinuation of study medication)
Symptoms of anxiety assessed using the 6-item short-form State-Trait Anxiety Inventory (STAI). Total scores range from 20 to 80 after score transformation, with higher scores indicating greater anxiety symptoms
Assessed at 160 weeks (end of treatment) and at 172-184 weeks (3-6 months after discontinuation of study medication)
Treatment satisfaction assessed using a study-specific questionnaire based on the Diabetes Treatment Satisfaction Questionnaire
大体时间：Assessed at 160 weeks (end of treatment) and at 172-184 weeks (3-6 months after discontinuation of study medication)
Diabetes risk perception assessed using the Diabetes Risk Perception Questionnaire, a validated questionnaire that evaluates perceived risk of developing diabetes
Assessed at 160 weeks (end of treatment) and at 172-184 weeks (3-6 months after discontinuation of study medication)
Sleep quality (Pittsburgh Sleep Quality Index)
大体时间：Assessed at 160 weeks (end of treatment) and at 172-184 weeks (3-6 months after discontinuation of study medication)
Sleep quality assessed using the validated Pittsburgh Sleep Quality Index (PSQI)
Assessed at 160 weeks (end of treatment) and at 172-184 weeks (3-6 months after discontinuation of study medication)
Food security (short-form HFSSM)
大体时间：Assessed at 160 weeks (end of treatment) and at 172-184 weeks (3-6 months after discontinuation of study medication)
Food security assessed using the short-form Household Food Security Survey Module (HFSSM). Scores indicate the level of food security, with higher scores reflecting greater food insecurity
Assessed at 160 weeks (end of treatment) and at 172-184 weeks (3-6 months after discontinuation of study medication)
Plasma metabolite concentrations
大体时间：Assessed at 160 weeks (end of treatment) and at 172-184 weeks (3-6 months after discontinuation of study medication)
Changes in and associations of metabolomic profiles, with cardiometabolic risk and treatment response. Assessed using metabolomic profiling. Blood samples will be collected at baseline and every 6 months during a 3.5-year follow-up period (study visits).
Assessed at 160 weeks (end of treatment) and at 172-184 weeks (3-6 months after discontinuation of study medication)
Quality-adjusted life years (QALYs)
大体时间：Assessed at 160 weeks (end of treatment) and at 172-184 weeks (3-6 months after discontinuation of study medication)
Quality-adjusted life years (QALYs), calculated as the area under the curve of health-related quality of life utility values over time, where higher values indicate better health outcomes
Assessed at 160 weeks (end of treatment) and at 172-184 weeks (3-6 months after discontinuation of study medication)
Incremental costs and incremental cost-effectiveness ratio (ICER) of semaglutide compared with placebo
大体时间：Assessed at 160 weeks (end of treatment) and at 172-184 weeks (3-6 months after discontinuation of study medication)
Incremental costs and incremental cost-effectiveness ratio (ICER) of semaglutide versus placebo
Assessed at 160 weeks (end of treatment) and at 172-184 weeks (3-6 months after discontinuation of study medication)
Incremental healthcare costs
大体时间：Assessed at 160 weeks (end of treatment) and at 172-184 weeks (3-6 months after discontinuation of study medication)
Incremental healthcare costs associated with the intervention compared with control, calculated from collected healthcare resource utilization and unit cost data. Currency (e.g., EUR per participant)
Assessed at 160 weeks (end of treatment) and at 172-184 weeks (3-6 months after discontinuation of study medication)

合作者和调查者

在这里您可以找到参与这项研究的人员和组织。

赞助

Universitaire Ziekenhuizen KU Leuven

合作者

Universitair Ziekenhuis Brussel
University Hospital, Antwerp
Onze Lieve Vrouw Hospital
General Hospital Groeninge
AZ Turnhout
Erasme University Hospital
AZ Sint-Lucas Brugge
Centre Hospitalier Universitaire de Liege
Vitaz
Centre Hospitalier Mouscron
Jan Yperman Ziekenhuis
Ziekenhuis aan de Stroom

出版物和有用的链接

负责输入研究信息的人员自愿提供这些出版物。这些可能与研究有关。

一般刊物

有用的网址

研究记录日期

这些日期跟踪向 ClinicalTrials.gov 提交研究记录和摘要结果的进度。研究记录和报告的结果由国家医学图书馆 (NLM) 审查，以确保它们在发布到公共网站之前符合特定的质量控制标准。

研究主要日期

学习开始 (实际的)

2023年9月14日

初级完成 (估计的)

2030年3月1日

研究完成 (估计的)

2030年5月1日

研究注册日期

首次提交

2022年9月28日

首先提交符合 QC 标准的

2022年10月3日

首次发布 (实际的)

2022年10月6日

研究记录更新

最后更新发布 (实际的)

2026年9月15日

上次提交的符合 QC 标准的更新

2026年9月11日

最后验证

2026年9月1日

更多信息

与本研究相关的术语

关键字

其他相关的 MeSH 术语

其他研究编号

  • S66967
  • 2022-502082-22-00 (其他标识符：EU CT number)

计划个人参与者数据 (IPD)

计划共享个人参与者数据 (IPD)？

是的

IPD 计划说明

Individual participant data will be made available upon reasonable request after study completion, database lock, unblinding, and publication of the primary results, subject to applicable ethical, legal, and data protection requirements.

药物和器械信息、研究文件

研究美国 FDA 监管的药品

不

研究美国 FDA 监管的设备产品

不

在美国制造并从美国出口的产品

不

此信息直接从 clinicaltrials.gov 网站检索，没有任何更改。如果您有任何更改、删除或更新研究详细信息的请求，请联系 register@clinicaltrials.gov. clinicaltrials.gov 上实施更改，我们的网站上也会自动更新.

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