Exenatide Pharmacokinetics and Pharmacodynamics in Gestational Diabetes

Description

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.

Conditions

Gestational Diabetes

Study Overview

Study Details

Study overview

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.

Pilot Study of Exenatide Pharmacokinetics and Pharmacodynamics in Gestational Diabetes

Exenatide Pharmacokinetics and Pharmacodynamics in Gestational Diabetes

Condition
Gestational Diabetes
Intervention / Treatment

-

Contacts and Locations

Pittsburgh

Magee Womens Hospital of UPMC, Pittsburgh, Pennsylvania, United States, 15213

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

For general information about clinical research, read Learn About Studies.

Eligibility Criteria

  • * Pregnant women (singleton)
  • * Gestational diabetes not requiring medical therapy
  • * Between 18 and 50 years of age
  • * Able to give written informed consent
  • * 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)

Ages Eligible for Study

18 Years to 50 Years

Sexes Eligible for Study

FEMALE

Accepts Healthy Volunteers

No

Collaborators and Investigators

Maisa N. Feghali, MD,

Maisa Feghali, MD, PRINCIPAL_INVESTIGATOR, University of Pittsburgh

Study Record Dates

2024-12-31