Prebiotics and Metformin Improve Gut and Hormones in Type 2 Diabetes in Youth (MIGHTY-fiber)
Public ClinicalTrials.gov record NCT04209075. Field values are reproduced from the official study page; the official ClinicalTrials.gov record remains the source of truth for eligibility, enrollment, and contact information.
Data is sourced from official ClinicalTrials.gov public API records. Always review the official ClinicalTrials.gov record for the latest information.
Official title
Prebiotics and Metformin Influences Gut and Hormones in Type 2 Diabetes Youth (MIGHTY)
Brief summary
Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.
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...
Study identification
- NCT ID
- NCT04209075
- Recruitment status
- Completed
- Study type
- Interventional
- Phase
- Phase 2
- Enrollment
- 6 participants
Conditions and interventions
Conditions
Interventions
- Biomebliss Dietary Supplement
- Metformin Drug
- Placebo Dietary Supplement
Dietary Supplement · Drug
Eligibility (public fields only)
- Age range
- 10 Years to 25 Years
- Sex
- All
- Healthy volunteers
- Healthy volunteers not accepted
This page does not interpret eligibility. Detailed inclusion and exclusion criteria are on the official ClinicalTrials.gov record.
Study timeline
- Start date
- Mar 9, 2020
- Primary completion
- Jul 14, 2021
- Completion
- Jul 14, 2021
- Last update posted
- Aug 29, 2022
2020 – 2021
United States locations
- U.S. sites
- 1
- U.S. states
- 1
- U.S. cities
- 1
| Facility | City | State | ZIP | Site status |
|---|---|---|---|---|
| National Institutes of Health Clinical Center | Bethesda | Maryland | 20892 | — |
Site contact phone numbers, emails, and investigator names are intentionally not displayed here. Open the official ClinicalTrials.gov record for site contact information.
About this trial record page
- What this page shows
- Public field values for ClinicalTrials.gov record NCT04209075, including study identification, conditions, interventions, eligibility (age, sex, healthy volunteer), timeline, and U.S. site list.
- What this page does not do
- No medical advice, eligibility judgments, treatment recommendations, study quality scoring, or AI-generated medical summaries. No site contact phone numbers, emails, or investigator names.
- Where the data comes from
- Sourced from the official ClinicalTrials.gov public API. The official record is the source of truth.
- Last refresh
- Last update posted Aug 29, 2022 · Synced Sep 2, 2026
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Open the official record
The complete protocol, eligibility criteria, and contact information for NCT04209075 live on ClinicalTrials.gov.