RECRUITING

Exenatide Pharmacokinetics and Pharmacodynamics in Gestational Diabetes

Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

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.

Official Title

Pilot Study of Exenatide Pharmacokinetics and Pharmacodynamics in Gestational Diabetes

Quick Facts

Study Start:2023-04-12
Study Completion:2024-12-31
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:RECRUITING

Study ID

NCT05482789

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.

Ages Eligible for Study:18 Years to 50 Years
Sexes Eligible for Study:FEMALE
Accepts Healthy Volunteers:No
Standard Ages:ADULT
Inclusion CriteriaExclusion Criteria
  1. * Pregnant women (singleton)
  2. * Gestational diabetes not requiring medical therapy
  3. * Between 18 and 50 years of age
  4. * Able to give written informed consent
  1. * Women in the first trimester of pregnancy
  2. * Hematocrit less than 30%
  3. * Current or past treatment with any hypoglycemic agent
  4. * Women with gastrointestinal disease or symptoms consistent with nausea, vomiting, abdominal pain or reflux requiring medical treatment.
  5. * Women with high triglyceride levels, history of gallbladder or pancreatic disease.
  6. * Clinical diagnosis or history of any renal insufficiency (or decreased creatinine clearance)

Contacts and Locations

Study Contact

Maisa Feghali, MD
CONTACT
412 647 1000
feghalim@upmc.edu

Principal Investigator

Maisa Feghali, MD
PRINCIPAL_INVESTIGATOR
University of Pittsburgh

Study Locations (Sites)

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

Collaborators and Investigators

Sponsor: Maisa N. Feghali, MD

  • Maisa Feghali, MD, PRINCIPAL_INVESTIGATOR, University of Pittsburgh

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2023-04-12
Study Completion Date2024-12-31

Study Record Updates

Study Start Date2023-04-12
Study Completion Date2024-12-31

Terms related to this study

Additional Relevant MeSH Terms

  • Gestational Diabetes