Open studies conducted by NIDDK Principal Investigators appear below. Study statuses may include the following:
Open: Recruiting - Currently recruiting participants and open to everyone who meets eligibility criteria.
Open: Active, Not Recruiting - Participants are receiving an intervention or being examined, however new participants
are not being recruited or enrolled.
Open: Enrolling by Invitation - People in a particular population were selected in advance and invited to participate.
The study is not open to everyone who meets the eligibility criteria.
Open: Available for Expanded Access - Patients who are not participants in the clinical study may be able to
gain access to the drug, biologic, or medical device being studied.
Background:
Metformin is a pill youth with type 2 diabetes take. It can cause side effects like diarrhea
and upset stomach. Researchers want to see if a fiber supplement can help decrease these side
effects.
Objective:
To see if a prebiotic fiber supplement helps improve the gastrointestinal side effects of
people taking metformin and helps with their blood sugars.
Eligibility:
People ages 10-25 with type 2 diabetes who are taking or will take metformin
Design:
Participants will be screened with:
Physical exam
Medical history
Blood and urine tests
Meeting with a nutritionist
Participants will stop taking all diabetes medication for 1 week. They will then take
metformin by mouth for 1 week. They will be randomly assigned to take either a fiber
supplement or a placebo by mouth during the same week. They will then stop all study
treatments for 2-3 weeks. Then they will restart metformin for 1 week. The groups that
received the fiber versus the placebo will be reversed. All participants will then continue
taking metformin and take the fiber for 1 month.
Participants will have 6 visits over about 2 months. These will include:
Blood and urine tests
Meal tests: A plastic tube will be inserted in the participant s arm vein for blood draws.
They will drink a special meal.
DXA scan: Participants will lie on their back while the scan measures their body fat and
muscle.
While they are home, participants will:
Fill out daily surveys online
Wear daily activity and blood sugar monitors
Collect their stool
Eat only certain foods for two 1-week periods...
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....
