Title: Therapeutic Targets in African-American Youth With Type 2 Diabetes

Part of paid clinical trials in Bethesda, Maryland.

Sponsor
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
Study ID
NCT02960659
Phase
PHASE1/PHASE2
Status
Completed

Conditions

Eligibility Criteria

Sex
ALL
Age
12 Years - 25 Years
Healthy Volunteers
Not accepted

Interventions

  • Liraglutide — DRUG
    Liraglutide (6mg/ml, 3ml ) solution for subcutaneous injection, pre-filled, multi-dose pen that delivers doses of 0.6mg, 1.2mg or 1.8mg.
  • Metformin — DRUG
    Metformin 500mg oral tablet

Study Details

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 12-25 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....

Key Dates

Start date
May 9, 2017
Status verified
Apr 2023
Primary completion
May 20, 2022
Completion
May 20, 2022

Study Design

Enrollment
24 participants (actual)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
BASIC_SCIENCE

Arms

  • Active Comparator: Metformin
    Standard release metformin (500 mg tablets) was initiated and titrated to maximum dose of metformin 1000 mg twice daily over 3 weeks and continued for 12 weeks
  • Experimental: Metformin and liraglutide
    Standard release metformin (500 mg tablets) and liraglutide (0.6mg) were initiated and titrated to maximum dose of metformin 1000 mg twice daily, and liraglutide 1.8 mg daily over 3 weeks and continued for 12 weeks

Primary Outcome Measure

Change in Absolute Gluconeogenesis From Baseline to 12 Weeks [ Time Frame: Baseline to 12 weeks ]

Locations (1)

FacilityCityStateZIPSite coordinators
National Institutes of Health Clinical CenterBethesdaMaryland20892-

Find similar trials in Bethesda, MD

By condition
Type 2 diabetes
By specialty
EndocrinologyMetabolic healthWeight loss
By research site
National Institutes of Health Clinical Center· Bethesda, MD

Related Studies