Prebiotics and Metformin Improve Gut and Hormones in Type 2 Diabetes in Youth (MIGHTY-fiber)

PHASE2CompletedINTERVENTIONAL
Enrollment

6

Participants

Timeline

Start Date

March 10, 2020

Primary Completion Date

July 15, 2021

Study Completion Date

July 15, 2021

Conditions
Diabetes
Interventions
DIETARY_SUPPLEMENT

Biomebliss

BiomeBliss is a commercially available powder containing prebiotic fiber (inulin and beta glucan), along with blueberry extract providing polyphenols.

DRUG

Metformin

Metformin is a commonly used antidiabetic medication, and the only oral medication approved for children and adolescents under 18 years old. Though reasonably effective, gastro-intestinal side effects are common (80% at initiation, and 10-30% after long term use). Metformin dosing at clinically recommended doses will be titrated per protocol during the study.

DIETARY_SUPPLEMENT

Placebo

Placebo Comparator

Trial Locations (1)

20892

National Institutes of Health Clinical Center, Bethesda

All Listed Sponsors
lead

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

NIH

NCT04209075 - Prebiotics and Metformin Improve Gut and Hormones in Type 2 Diabetes in Youth (MIGHTY-fiber) | Biotech Hunter | Biotech Hunter