RecruitingPhase 4NCT05482789

Exenatide Pharmacokinetics and Pharmacodynamics in Gestational Diabetes

Pilot Study of Exenatide Pharmacokinetics and Pharmacodynamics in Gestational Diabetes


Sponsor

Maisa N. Feghali, MD

Enrollment

13 participants

Start Date

Apr 12, 2023

Study Type

INTERVENTIONAL

Conditions

Summary

This study is being done to study how exenatide, an FDA-approved drug that lowers blood sugar in non-pregnant patients with type II diabetes, works in pregnant women. To do this, the investigators will study the drug's pharmacokinetics (what the body does to the drug; specifically, how quickly your body breaks down and excretes exenatide) and pharmacodynamics (what the drug does to the body; specifically, how effectively exenatide helps the participants' pancreas secrete insulin and how well it controls blood sugar after a meal). There are only two main drug therapies (insulin injections and glyburide pills) currently used for gestational diabetes and not all women achieve good enough blood sugar control without side effects. Therefore, the investigators hope to find out if exenatide might also be helpful in gestational diabetes.


Eligibility

Sex: FEMALEMin Age: 18 YearsMax Age: 50 Years

Plain Language Summary

Simplified for easier understanding

This study investigates how exenatide — an FDA-approved blood sugar medication used in non-pregnant type 2 diabetes patients — works in pregnant women with gestational diabetes. Researchers want to understand how quickly the body processes exenatide and how effectively it helps control blood sugar after meals, since current options (insulin and glyburide) don't work well for all women. Eligible participants are pregnant women aged 18–50 with gestational diabetes not yet requiring medication, who are carrying a single baby and have no history of blood sugar treatment or significant gastrointestinal, kidney, or pancreatic conditions. Participation involves pharmacokinetic and pharmacodynamic testing to measure how the drug moves through the body and affects insulin secretion. This summary was prepared as patient-facing educational content using AI assistance.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DRUGExenatide

10 microgram injected sub-cutaneously once


Locations(1)

Magee Womens Hospital of UPMC

Pittsburgh, Pennsylvania, United States

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NCT05482789


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