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NCT04209075 · ClinicalTrials.gov registry record · Phase 2
Prebiotics and Metformin Improve Gut and Hormones in Type 2 Diabetes in Youth (MIGHTY-fiber)
A Phase 2 study, sponsored by National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK).
- Completed
- Registry status
- Phase 2
- Development phase
- 6
- Enrollment target
NCT04209075: Completed Phase 2 study, sponsored by National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK).
NCT04209075 is a Phase 2 study that has completed, run by National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK). The registered enrollment target is 6 participants, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (95% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT04209075, a Phase 2 study, has completed, sponsored by National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK).
- COMPLETED
- Registry status
- Phase 2
- Development phase
- 6 participants
- Enrollment target
Study 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...
Primary Outcome
A composite tolerability score based on 4 GI side effect profile categories (stool consistency, urgency to evacuate, bloating sensation, and flatulence), assessed by daily survey, will be calculated using a principal components analysis. A scale range of GI tolerability score is (1.14, 3.3). A higher tolerability score indicates a lower side effect profile
Interventions
- DIETARY_SUPPLEMENT Placebo
- DRUG Metformin
- DIETARY_SUPPLEMENT Biomebliss
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 6 participants |
| Start Date | 2020-03-10 |
| Est. Completion | 2021-07-15 |
| Phase | Phase 2 |
What the finished NCT04209075 record still lists
NCT04209075 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 6 participants, a relatively small participant target, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (95% lower).
The record links to 0 conditions, and to 3 interventions - of which Placebo is the first listed.
NCT04209075 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT04209075 about?
NCT04209075 is a clinical study titled "Prebiotics and Metformin Improve Gut and Hormones in Type 2 Diabetes in Youth (MIGHTY-fiber)". 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...
What is the current status of trial NCT04209075?
This trial is currently completed. It is a Phase 2 study. The enrollment target is 6 participants. The study started on 2020-03-10. Estimated completion is 2021-07-15.
What interventions are being tested in trial NCT04209075?
The interventions under investigation include: Placebo (DIETARY_SUPPLEMENT), Metformin (DRUG), Biomebliss (DIETARY_SUPPLEMENT).
Who is sponsoring clinical trial NCT04209075?
This trial is sponsored by National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK), which has 490 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT04209075's enrollment target sits among peer trials
6 1996th of 2000 higher than 1 of 2,000 other Phase 2 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 2 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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