Examining how exenatide works in pregnant women with gestational diabetes
Pilot Study of Exenatide Pharmacokinetics and Pharmacodynamics in Gestational Diabetes
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 |
| Enrollment | 13 (estimated) |
| Ages | 18 Years to 50 Years |
| Sex | Female |
| Sponsor | University of Pittsburgh Academic / other |
| Locations | 1 site (Pittsburgh, Pennsylvania) |
| Trial ID | NCT05482789 on ClinicalTrials.gov |
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.
Who should consider this trial
Good fit: Ideal candidates for this study are pregnant women aged 18 to 50 with gestational diabetes that does not require medical therapy.
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.
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 performed: While there are limited studies specifically on exenatide for gestational diabetes, the use of similar pharmacological approaches in other populations has shown promise.
Eligibility criteria
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 this trial is running
Pittsburgh, Pennsylvania
- 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
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.