Gestational Diabetes Mellitus (GDM), Metabolic Syndrome
Conditions
Keywords
postpartum, gestational diabetes mellitus, metabolic syndrome, GLP-1 receptor agonist, semaglutide
Brief summary
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.
Interventions
The intervention 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.
Sponsors
University of Massachusetts, Worcester
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
SINGLE (Outcomes Assessor)
Eligibility
Sex/Gender
FEMALE
Age
18 Years to 65 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Metabolic Syndrome | 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 (women) and fasting blood sugar greater than or equal to 110 mg/dL. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Percent Weight Loss | 3, 6, and 12 months after randomization | Calculated from measured weight at baseline and from initial prenatal visit weight |
| Body Mass Index | Baseline, 3, 6, and 12 months after randomization | Calculated from the height and weight |
| Waist Circumference | Baseline, 3, 6, and 12 months after randomization | Standardized anthropometric measurement in centimeters |
| Systolic and Diastolic Blood Pressure | Baseline, 3, 6, and 12 months after randomization | Mean blood pressure from 3 automated measurements taken after resting for 5 minutes |
| Fasting Blood Sugar | Baseline, 3, 6, and 12 months after randomization | Laboratory assay of fasting blood sugar |
| Triglycerides | Baseline, 3, 6, and 12 months after randomization | Laboratory assay |
| HDL Cholesterol | Baseline, 3, 6, and 12 months after randomization | Laboratory assay |
| Type 2 Diabetes Mellitus | 3, 6, and 12 months after randomization | Diagnosed by a hemoglobin A1c greater than 6.4% |
| High sensitivity troponin | Baseline, 3, 6, and 12 months after randomization | Laboratory assay assessing cardiac injury |
Countries
United States
Contacts
CONTACTGianna L Wilkie, MD, MSc
Outcome results
None listed