Prebiotics and Metformin Improve Gut and Hormones in Type 2 Diabetes in Youth (MIGHTY-fiber)
Status:
Completed
Trial end date:
2021-07-15
Target enrollment:
Participant gender:
Summary
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.
Dual-energy x-ray absorptiometry (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...
Phase:
Phase 2
Details
Lead Sponsor:
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)