Postpartum Semaglutide to Reduce Cardiometabolic Risk After Gestational Diabetes: An Effectiveness-Implementation Hybrid Type 1 Randomized Trial
试验速览
- 阶段
- 2 期
- 状态
- 尚未招募
- 发起方
- 入组人数
- 226
- 试验地点
- 1
- 主要终点
- Metabolic Syndrome
研究概览
简要总结
This is an effectiveness-implementation Hybrid Type 1 study using a randomized clinical trial design to evaluate the effectiveness and potential real-world integration of immediate postpartum semaglutide following a pregnancy complicated by gestational diabetes mellitus (GDM). A total of 226 postpartum individuals with recent GDM will be randomized 1:1 to semaglutide or standard postpartum care for a 6-month active treatment phase. The primary effectiveness outcome, development of metabolic syndrome, will be assessed at 6 months postpartum. Participants will subsequently enter a 6-month maintenance phase, during which semaglutide continuation, discontinuation, or initiation will reflect patient preferences, clinical decision-making, medication access, and insurance coverage.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- Single (Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Age greater than or equal to 18
- •Postpartum state (delivered within 6 weeks)
- •Ability and willingness to provide informed consent
排除标准
- •a history of acute or chronic pancreatitis
- •personal or first-degree relative(s) history of multiple endocrine neoplasia type 2 or medullary thyroid carcinoma
- •diagnosis of pre-gestational diabetes (type 1 or 2 diabetes mellitus)
- •body mass index <25 kg/m2
- •Plan to attempt pregnancy within next 12 months or confirmed pregnancy
- •Known allergy to semaglutide from prior exposure
- •Previous participation in this trial
- •History of suicidal ideation/attempt in the past 12 months
- •Current or recent diagnosis in the last 12 months of anorexia nervosa, bulimia nervosa, binge eating disorder, or other eating disorder
- •Actively breastfeeding or lactating
研究组 & 干预措施
Semaglutide
The intervention/active arm is semaglutide initiated within 6 weeks of delivery and administered once weekly for 6 months to postpartum individuals following a pregnancy complicated by gestational diabetes mellitus (GDM). Participants randomized to the intervention arm will receive semaglutide in addition to standard postpartum care. Treatment will be initiated using a standardized dose-escalation regimen consistent with the approved prescribing approach to improve tolerability, with dose adjustments or discontinuation based on tolerability and clinical safety.
干预措施: Semaglutide (Wegovy) weekly injection (Drug)
Standard of Care
Participants randomized to the control arm will receive standard postpartum care following a pregnancy complicated by gestational diabetes mellitus (GDM). Standard care will include educational materials addressing postpartum diabetes screening, healthy nutrition, physical activity, weight management, and long-term cardiometabolic risk following GDM. Participants will otherwise receive routine clinical care according to their treating providers and will not receive study-provided semaglutide during the 6-month randomized active phase.
结局指标
主要结局
Metabolic Syndrome
时间窗: 6 months after randomization
Metabolic syndrome will be treated as a binary variable. Metabolic syndrome is defined as a cluster of cardiovascular risk factors that is defined as having three or more of the following five criteria: waist circumference over 88 centimeters in women, blood pressure greater than or equal to 130/85 mmHg, fasting triglyceride (TG) level greater than or equal to 150 mg/dL, fasting high-density lipoprotein (HDL) cholesterol level less than 50 mg/dl and fasting blood sugar greater than or equal to 110 mg/dL.
次要结局
- Concentration of Fasting Blood Sugar(Baseline, 3, 6, and 12 months after randomization)
- Concentration of Triglycerides(Baseline, 3, 6, and 12 months after randomization)
- Concentration of High Density Lipoprotein (HDL) Cholesterol(Baseline, 3, 6, and 12 months after randomization)
- Concentration of High sensitivity troponin(Baseline, 3, 6, and 12 months after randomization)
- Percent Weight Loss(3, 6, and 12 months after randomization)
- Body Mass Index(Baseline, 3, 6, and 12 months after randomization)
- Waist Circumference(Baseline, 3, 6, and 12 months after randomization)
- Systolic and Diastolic Blood Pressure(Baseline, 3, 6, and 12 months after randomization)
- Fasting Blood Sugar(Baseline, 3, 6, and 12 months after randomization)
- Triglycerides(Baseline, 3, 6, and 12 months after randomization)
- HDL Cholesterol(Baseline, 3, 6, and 12 months after randomization)
- Type 2 Diabetes Mellitus(3, 6, and 12 months after randomization)
- High sensitivity troponin(Baseline, 3, 6, and 12 months after randomization)
研究者
Gianna Wilkie
Assistant Professor of Obstetrics and Gynecology
University of Massachusetts, Worcester