Examining how exenatide works in pregnant women with gestational diabetes
Official title: Pilot Study of Exenatide Pharmacokinetics and Pharmacodynamics in Gestational Diabetes
Run by University of Pittsburgh · NCT05482789 · Data updated 2026-11-12
This study is testing how well the diabetes drug exenatide works in pregnant women with gestational diabetes to see if it can help control their blood sugar levels better.
Quick facts
| Phase | Phase 4 |
|---|---|
| Study type | Interventional |
| Ages | 18 Years to 50 Years |
| Sex | Women only |
| Enrollment | 13 (estimated) |
| Sponsor | University of Pittsburgh Academic / other |
| Locations | 1 site (Pittsburgh, Pennsylvania) |
| Status | Recruiting |
| Started | April 12, 2023 |
| Main results expected | December 31, 2025 |
| Study ends | December 31, 2026 |
| Registry record updated | April 20, 2026 |
| Trial ID | NCT05482789 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
Ideal candidates for this study are pregnant women aged 18 to 50 with gestational diabetes that does not require medical therapy.
✕Probably not a fit
Patients who are in their first trimester of pregnancy or have a history of gastrointestinal disease or renal insufficiency may not benefit from this study.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
What this trial studies
This study investigates the pharmacokinetics and pharmacodynamics of exenatide, a drug approved for type II diabetes, in pregnant women diagnosed with gestational diabetes. The research aims to understand how the body processes exenatide and its effectiveness in stimulating insulin secretion and controlling blood sugar levels after meals. Currently, there are limited treatment options for gestational diabetes, and this study seeks to explore a potential alternative therapy that may improve blood sugar management for affected women.
Why it matters
Potential benefit: If successful, this study could provide a new treatment option for managing blood sugar levels in pregnant women with gestational diabetes.
How similar studies have gone: While there are limited studies specifically on exenatide for gestational diabetes, the use of similar pharmacological approaches in other populations has shown promise.
Who can join: the full rules
Show full inclusion / exclusion criteria
Inclusion Criteria: * Pregnant women (singleton) * Gestational diabetes not requiring medical therapy * Between 18 and 50 years of age * Able to give written informed consent Exclusion Criteria: * Women in the first trimester of pregnancy * Hematocrit less than 30% * Current or past treatment with any hypoglycemic agent * Women with gastrointestinal disease or symptoms consistent with nausea, vomiting, abdominal pain or reflux requiring medical treatment. * Women with high triglyceride levels, history of gallbladder or pancreatic disease. * Clinical diagnosis or history of any renal insufficiency (or decreased creatinine clearance)
Where it's running
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Magee Womens Hospital of UPMC
Pittsburgh, Pennsylvania, United States Recruiting
Study contacts
- Principal investigator: Maisa Feghali, MD — University of Pittsburgh
- Study coordinator: Maisa Feghali, MD
- Email: feghalim@upmc.edu
- Phone: 412 647 1000
Similar studies
Other studies for the same condition or treatment. Recruiting studies are listed first.
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Early Glucose Patterns in Pregnant Women at Risk for GDM
This study tests whether continuous glucose monitoring in early pregnancy can detect dysglycemia before GDM is diagnosed, in women with and without known risk factors.
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Probiotic-augmented therapy for gestational diabetes
This trial tests whether adding multistrain probiotics to metformin, insulin, or their combination can improve blood sugar control and inflammation in pregnant women with gestational diabetes.
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Maternal insulin and fat metabolism in pregnancies at risk for preeclampsia and gestational diabetes
This project will try to see if insulin resistance and how the body burns fats early in pregnancy predict later preeclampsia or gestational diabetes in people at higher risk.
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How sleep, lifestyle, and metabolism relate to pregnancy outcomes in gestational diabetes
This project will see if sleep quality, anxiety, eating and activity habits, and metabolic markers relate to blood sugar control and birth outcomes in pregnant people with gestational diabetes.
-
Pre-eclampsia risk in pregnancies after oocyte donation
We will follow pregnant women who used donated eggs and women who used their own eggs to see if pregnancies after oocyte donation lead to a higher risk of pre-eclampsia.
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Mobile-based obstetric monitoring for hypertension and diabetes during pregnancy
A mobile app-based program lets pregnant people with high blood pressure or gestational diabetes track BP and glucose at home and share results with their care team to guide care.
How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.