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

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...

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

Sponsors & Collaborators

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

  lead NIH

Principal Investigators

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

Study Design

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

DOUBLE

Model

CROSSOVER

Eligibility

Min Age

10 Years

Max Age

25 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2020-03-10

Primary Completion

2021-07-15

Completion

2021-07-15

FDA Drug

Yes

Countries

• United States

Study Locations