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Sponsors and Collaborators: |
Georgetown University Washington Hospital Center |
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Information provided by: | Georgetown University |
ClinicalTrials.gov Identifier: | NCT00572689 |
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: | Non-Randomized, Open Label, Single Group Assignment, Pharmacokinetics/Dynamics Study |
Official Title: | Pilot Study of Exenatide Pharmacokinetics and Pharmacodynamics in Gestational Diabetes |
Estimated Enrollment: | 13 |
Study Start Date: | December 2007 |
Estimated Study Completion Date: | June 2008 |
Estimated Primary Completion Date: | June 2008 (Final data collection date for primary outcome measure) |
Arms | Assigned Interventions |
---|---|
A: Experimental
Subject receives injection of 10 micrograms of Exenatide sub-cutaneously the given mixed meal test and blood samples will be drawn for laboratory testing.
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Drug: Exenatide
10 microgram injected sub-cutaneously once
Genetic: Buccal Sample Collection
Buccal Sample collection for TCF7L2 polymorphism genetic testing
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B: No Intervention
Patients given mixed meal test and blood samples drawn for laboratory testing
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Ages Eligible for Study: | 18 Years to 50 Years |
Genders Eligible for Study: | Female |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Contact: Maisa N Feghali, MD | 202 415 9162 | maisafeghali@gmail.com |
Contact: Kimberly W Hickey, MD | 202 444 8801 | kwhickey@hotmail.com |
United States, District of Columbia | |
Georgetown University Medical Center | Recruiting |
Washington, District of Columbia, United States, 20007 | |
Contact: Maisa N Feghali, MD 202-415-9162 maisafeghali@gmail.com | |
Principal Investigator: Kimberly W Hickey, MD | |
Sub-Investigator: Jason G Umans, MD | |
Washington Hospital Center | Recruiting |
Washington, District of Columbia, United States, 20001 | |
Contact: Maisa N Feghali, MD 202-415-9162 maisafeghali@gmail.com | |
Sub-Investigator: Jason G Umans, MD | |
Sub-Investigator: Robert Ratner, MD |
Principal Investigator: | Kimberly W Hickey, MD | Georgetown University |
Study Chair: | Jason G Umans, MD | Georgetown University |
Study Director: | Maisa N Feghali, MD | Georgetown University |
Study Chair: | Robert Ratner, MD | Washington Hospital Center |
Responsible Party: | Georgetown University Medical Center ( Kimberly W Hickey ) |
Study ID Numbers: | Exenatide.GDM, 202 444 1202 |
Study First Received: | December 12, 2007 |
Last Updated: | May 13, 2008 |
ClinicalTrials.gov Identifier: | NCT00572689 History of Changes |
Health Authority: | United States: Institutional Review Board |
Exenatide TCF7L2 polymorphism Pharmacodynamics Pharmacokinetics |
Hypoglycemic Agents Pregnancy Complications Metabolic Diseases Exenatide Diabetes Mellitus |
Endocrine System Diseases Diabetes, Gestational Endocrinopathy Glucose Metabolism Disorders Metabolic Disorder |
Hypoglycemic Agents Pregnancy Complications Metabolic Diseases Exenatide Physiological Effects of Drugs |
Diabetes Mellitus Endocrine System Diseases Diabetes, Gestational Glucose Metabolism Disorders Pharmacologic Actions |