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| ID | Type | Description | Link |
|---|---|---|---|
| 202-801-2636 |
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| Name | Class |
|---|---|
| Medstar Health Research Institute | OTHER |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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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| B | No Intervention | Patients given mixed meal test and blood samples drawn for laboratory testing |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Exenatide | Drug | 10 microgram injected sub-cutaneously once |
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| Measure | Description | Time Frame |
|---|---|---|
| glycemic control through insulin, glucose, c-peptide and glucagon assays | duing testing days |
| Measure | Description | Time Frame |
|---|---|---|
| TCF7L2 polymorphism | During subject testing days | |
| Exenatide Pharmacodynamics and Pharmacokinetics | During testing days |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Jason G Umans, MD, PhD | Georgetown University Medical Center, Medstar Health Research Institute | Principal Investigator |
| Maisa N Feghali, MD | Medstar Health Research Institute | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Georgetown University Medical Center | Washington D.C. | District of Columbia | 20007 | United States | ||
| Washington Hospital Center |
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| ID | Term |
|---|---|
| D016640 | Diabetes, Gestational |
| ID | Term |
|---|---|
| D011248 | Pregnancy Complications |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
| D000091642 | Urogenital Diseases |
| D003920 | Diabetes Mellitus |
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| ID | Term |
|---|---|
| D000077270 | Exenatide |
| ID | Term |
|---|---|
| D010455 | Peptides |
| D000602 | Amino Acids, Peptides, and Proteins |
| D014688 | Venoms |
| D045424 | Complex Mixtures |
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| Buccal/blood Sample Collection | Genetic | Buccal/blood Sample collection for TCF7L2 polymorphism genetic testing |
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| Washington D.C. |
| District of Columbia |
| 20010 |
| United States |
| D044882 | Glucose Metabolism Disorders |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |
| D004700 | Endocrine System Diseases |
| D014118 |
| Toxins, Biological |
| D001685 | Biological Factors |