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The Children's Research Institute

Therapeutic Targets in African-American Youth With Type 2 Diabetes

Trial Number: NCT02960659

Background:The pill metformin treats diabetes. But it does not work for all youth, especiallyAfrican-Americans. The injectable Liraglutide treats type 2 diabetes in adults. Researcherswant to understand how these drugs work and if they decrease excess sugar made by the liverin youth with type 2 diabetes.Objective:To test if using liraglutide and metformin are better than just metformin for decreasingexcess sugar produced by the liver in African-American youth with type 2 diabetes.Eligibility:African-Americans ages 12-21 with type 2 diabetesDesign:Visit 1: Participants will be screened with medical history, physical exam, and blood andurine tests.Participants will stop taking diabetes medicines for 1 week. They will learn how to checkblood 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 fatwith 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 justmetformin daily.Visits 3 4: Participants will bring their blood sugar records and have blood tests.Visit 5, after 3 months: Repeat of visit 2....

Eligibility

Ages Eligible for Study: 12 Years to 21 Years
Genders Eligible for Study: All
Accepts Healthy Volunteers: No
Phase: Phase 1
Expected Completion Date: 08/31/2019

Criteria

- INCLUSION CRITERIA:
1. Youth must self-identify as African-American and identify both parents as
African-American
2. Age 12-21 years
3. Pubertal or post-pubertal: Girls Tanner stage IV-V breast; Boys Testicular volume
11-25cc
4. Diagnosis of type 2 diabetes of <3 years duration
5. Hemoglobin A1C <9% at study initiation
6. Negative to mild ketonuria without acidosis (negative or 1+ ketones on
urinalysis)
7. Negative test for diabetes-related autoantibodies (glutamic acid decarboxylase 65
and tyrosine phosphataserelated islet antigen 2 (IA-2))
8. Willing and able to take daily medications and check blood glucose levels at
least twice per day
EXCLUSION CRITERIA:
1. Pregnancy or breastfeeding
2. Allergy to study medications
3. Allergy to milk protein
4. Chronic insulin therapy
5. Treatment with other medications which are known to affect the parameters under study
6. Metabolic derangement such as metabolic acidosis, severe hyperglycemia (fasting blood
glucose greater than or equal to 200mg/dL), and/or liver enzymes > three times the
upper limit of normal.
7. Personal or family history of medullary thyroid cancer or Multiple Endocrine Neoplasia
syndrome type 2
8. Any other condition that, in the opinion of the investigators, will increase risk to
the subject, or impede the accurate collection of study-related data.
9. Body weight greater than or equal to 450 lbs
10. Body weight less than or equal to 58kg
11. Serum triglyceride concentrations greater than or equal to 500mg/dl
12. Hemoglobin concentration <11g/dL

Full study details on ClinicalTrials.gov

Contact Information

Principal Investigator:
Stephanie T Chung, M.D. - National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)

Contact:
Stephanie T Chung, M.D.
Phone: (301) 402-2122