Title: Therapeutic Targets in African-American Youth With Type 2 Diabetes
Status:
Recruiting
Trial end date:
2022-12-31
Target enrollment:
Participant gender:
Summary
Background:
The pill metformin treats diabetes. But it does not work for all youth, especially
African-Americans. The injectable Liraglutide treats type 2 diabetes in adults. Researchers
want to understand how these drugs work and if they decrease excess sugar made by the liver
in youth with type 2 diabetes.
Objective:
To test if using liraglutide and metformin are better than just metformin for decreasing
excess sugar produced by the liver in African-American youth with type 2 diabetes.
Eligibility:
African-Americans ages 12-21 with type 2 diabetes
Design:
Visit 1: Participants will be screened with medical history, physical exam, and blood and
urine tests.
Participants will stop taking diabetes medicines for 1 week. They will learn how to check
blood sugars at home twice a day.
Visit 2: Overnight at the clinic. Participants will have:
Vital signs taken.
Pregnancy test.
A thin plastic tube (IV catheter) be inserted in each forearm by needle.
Blood drawn several times after drinking a sweet drink.
X-ray of total body fat.
Urine and stool collected.
Breath tests while wearing a clear hood for up to 45 minutes.
For several hours, participants can have only water. At 4 a.m. they will get sugar and fat
with nonradioactive isotopes in one IV. Blood will be collected. Every 30 minutes from 9 a.m.
to 2 p.m., they will drink small amounts of a shake and have blood drawn.
Participants will be randomly assigned to take either both study drugs daily or just
metformin daily.
Visits 3-4: Participants will bring their blood sugar records and have blood tests.
Visit 5, after 3 months: Repeat of visit 2....
Phase:
Phase 1
Details
Lead Sponsor:
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)