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Набира участници Фаза 4 NCT05482789

Exenatide Pharmacokinetics and Pharmacodynamics in Gestational Diabetes

Фаза 4 – наблюдение след одобрението на пазара
Заболявания: Gestational Diabetes

Спонсор: Maisa N. Feghali, MD

Налично на: БГ
Обобщение
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.
Кой може да участва
Inclusion Criteria: * Pregnant women (singleton) * Gestational diabetes not requiring medical therapy * Between 18 and 50 years of age * Able to give written informed consent Exclusion Criteria: * 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)
Интервенции
Exenatide
DRUG
Места на провеждане 1
САЩ (1)
Magee Womens Hospital of UPMC
Pittsburgh , Pennsylvania
Технически детайли
Статус
Набира участници
Фаза
Фаза 4
Вид изследване
INTERVENTIONAL
Пол
Само жени
Минимална възраст
18 Years
Максимална възраст
50 Years
Здрави доброволци
Не
Начална дата
12.04.2023
Крайна дата
31.12.2026
Регистрационен номер
NCT05482789
Източник
clinicaltrials.gov
Запитване за медицински туризъм

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