Postpartum Semaglutide to Reduce Cardiometabolic Risk After Gestational Diabetes Mellitus

Phase 3Not Yet RecruitingNCT07797036

University of Massachusetts, Worcester226 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

PREVENTION

Masking

SINGLE

Enrollment

226

Conditions

Gestational Diabetes Mellitus (GDM)Metabolic Syndrome

Interventions

Eligibility

Sex: FEMALEMin age: 18 YearsMax age: 65 Years

Medical Language ↔ Plain English

Inclusion Criteria: * Age greater than or equal to 18 * Postpartum state (delivered within 6 weeks) * Ability and willingness to provide informed consent Exclusion Criteria: * 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

Outcomes

Primary Outcomes

Metabolic Syndrome

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.

Time frame: 6 months after randomization

Secondary Outcomes

Percent Weight Loss

Calculated from measured weight at baseline and from initial prenatal visit weight

Time frame: 3, 6, and 12 months after randomization

Body Mass Index

Calculated from the height and weight