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

NCT02960659 · Status: COMPLETED · Phase: PHASE1/PHASE2 · Type: INTERVENTIONAL · Enrollment: 24

Last updated 2023-08-01

Study results available
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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 12-25 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....

Conditions

Interventions

DRUG

Liraglutide

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

DRUG

Metformin

Metformin 500mg oral tablet

Sponsors & Collaborators

  • Children's National Research Institute

    collaborator OTHER

  • National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)

    lead NIH

Principal Investigators

  • Stephanie T Chung, MBBS · National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)

Study Design

Allocation
RANDOMIZED
Purpose
BASIC_SCIENCE
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
12 Years
Max Age
25 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2017-05-09
Primary Completion
2022-05-20
Completion
2022-05-20
FDA Drug
Yes

Countries

  • United States

Study Locations

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Entities

Drugs
Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02960659 on ClinicalTrials.gov