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| Sponsor: | Georgetown University |
|---|---|
| Collaborator: |
Washington Hospital Center |
| Information provided by (Responsible Party): | Kim W Hickey, Georgetown University |
| ClinicalTrials.gov Identifier: | NCT00572689 |
Purpose
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, we 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 your 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, we hope to find out if exenatide might also be helpful in gestational diabetes.
| Condition | Intervention | Phase |
|---|---|---|
|
Gestational Diabetes |
Drug: Exenatide Genetic: Buccal Sample Collection |
Phase IV |
| Study Type: | Interventional |
| Study Design: | Allocation: Non-Randomized Endpoint Classification: Pharmacokinetics/Dynamics Study Intervention Model: Single Group Assignment Masking: Open Label |
| Official Title: | Pilot Study of Exenatide Pharmacokinetics and Pharmacodynamics in Gestational Diabetes |
| Estimated Enrollment: | 13 |
| Study Start Date: | March 2011 |
| Estimated Study Completion Date: | December 2013 |
| Estimated Primary Completion Date: | June 2013 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Experimental: A
Subject receives injection of 10 micrograms of Exenatide sub-cutaneously the given mixed meal test and blood samples will be drawn for laboratory testing.
|
Drug: Exenatide
10 microgram injected sub-cutaneously once
Other Name: Byetta
Genetic: Buccal Sample Collection
Buccal Sample collection for TCF7L2 polymorphism genetic testing
|
|
No Intervention: B
Patients given mixed meal test and blood samples drawn for laboratory testing
|
Eligibility| Ages Eligible for Study: | 18 Years to 50 Years |
| Genders Eligible for Study: | Female |
| Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Contacts and Locations| Contact: Maisa N Feghali, MD | 202 801 4987 | maisafeghali@gmail.com |
| Contact: Jason G Umans, MD, PhD | 301 560 2959 | jason.umans@gmail.com |
| United States, District of Columbia | |
| Georgetown University Medical Center | Recruiting |
| Washington, District of Columbia, United States, 20007 | |
| Contact: Maisa N Feghali, MD 202-801-4987 maisafeghali@gmail.com | |
| Principal Investigator: Jason G Umans, MD, PhD | |
| Washington Hospital Center | Recruiting |
| Washington, District of Columbia, United States, 20010 | |
| Contact: Maisa N Feghali, MD 202-801-4987 maisafeghali@gmail.com | |
| Principal Investigator: Jason G Umans, MD, PhD | |
| Principal Investigator: | Jason G Umans, MD, PhD | Georgetown University Medical Center, Medstar Health Research Institute |
| Study Director: | Maisa N Feghali, MD | Washington Hospital Center |
More Information
| Responsible Party: | Kim W Hickey, Maternal Fetal Medicine specialist - Assistant professor, Georgetown University |
| ClinicalTrials.gov Identifier: | NCT00572689 History of Changes |
| Other Study ID Numbers: | Exenatide.GDM, 202 801 4987 |
| Study First Received: | December 12, 2007 |
| Last Updated: | November 1, 2011 |
| Health Authority: | United States: Institutional Review Board |
|
Exenatide TCF7L2 polymorphism Pharmacodynamics Pharmacokinetics |
|
Diabetes Mellitus Diabetes, Gestational Glucose Metabolism Disorders Metabolic Diseases Endocrine System Diseases |
Pregnancy Complications Exenatide Hypoglycemic Agents Physiological Effects of Drugs Pharmacologic Actions |