Phase 2
Completed N=6
Prebiotics and Metformin Improve Gut and Hormones in Type 2 Diabetes in Youth (MIGHTY-fiber)
Source: ClinicalTrials.gov NCT04209075 ↗Enrolled (actual)
6
Serious AEs
0.0%
Results posted
Aug 2022
Primary outcomePrimary: Gastrointestinal (GI) Tolerability Score — 2.31; 2.63; 2.70; 2.71 score on a scale
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...
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Gastrointestinal (GI) Tolerability Score |
2.31; 2.63; 2.70; 2.71 | — |
| SECONDARY Stool Short Chain Fatty Acids (SCFA) |
— | — |
Eligibility Criteria
- INCLUSION CRITERIA:
- Age 10-25 years
- Pubertal or post-pubertal: Girls - Tanner stage IV-V breast; Boys - Testicular volume >10cc
- Diagnosis of type 2 diabetes by American Diabetes Association (ADA) guidelines [36] or with established diagnosis previously treated with metformin.
- Negative test for diabetes-related autoantibodies (glutamic acid decarboxylase 65 and tyrosine phosphatase-related islet antigen 2 (IA-2)) documented in NIH CRIS chart or via outside laboratory assessment within the last 10 years.
- Hemoglobin A1C =6 oz per day)
- Chronic GI disease, gastric bypass surgery, cancer diagnosis or autoimmune disease
- Metabolic derangement such as metabolic acidosis, severe hyperglycemia (fasting blood glucose >= 200mg/dL), and/or liver enzymes > three times the upper limit of normal.
- Any other condition that, in the opinion of the investigators, will increase risk to the subject, or impede the
accurate collection of study-related data.
- Body weight >= 450lbs
- Body weight <=58kg
- Hemoglobin concentration <10g/dL
Data sourced from ClinicalTrials.gov (NCT04209075). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.