The goal of this study is to learn more about inflammation and how well the kidneys and blood vessels work in young adults with type 2 diabetes (T2D).
This study looks at how inflammation may affect kidney and blood vessel health in young adults with T2D. People with T2D often have higher levels of inflammation. Researchers want to find out if montelukast, a drug that lowers certain chemicals linked to inflammation, can help kidney and blood vessel function. At the first study visit, the study team will see if you qualify for the study. They will ask about your health history, check your vital signs, do a physical exam, and collect blood and urine samples. If you qualify, you will return for a study visit that will last about 5 to 6 hours. Before the visit, the study team will ask you to follow some instructions. You will then be randomly assigned, like flipping a coin, to get either montelukast or a placebo, which is a pill with no active drug. You will take one study tablet each day for 6 months. During this visit, the study team will collect blood and urine samples and do tests to check how well your blood vessels, heart, and kidneys are working. You will also answer questions about your sleep and any symptoms of anxiety or depression. You will return for study visits at 3 months and 6 months to do similar tests and questionnaires. About 2 weeks after your last study visit, the study team will call you for a follow-up visit. There will be 4 in-person study visits, and you will be in the study for about 8 months. There is no cost to take part in the study. You can earn up to $400 if you complete all study visits.
You may be able to join this study if you are 14 to 24 years old, have a history of T2D, and have been taking the same medications for at least 1 month. You cannot join if you have had diabetic ketoacidosis or severe high blood sugar in the past 60 days, uncontrolled high blood pressure, or serious kidney disease. You also cannot join if you are pregnant, plan to become pregnant, are breastfeeding, or are taking part in another research study. Some health problems, allergies, or medicines may also prevent you from joining. The study team will review all requirements with you.
Protocol Number: 25-2690
Principal Investigator