Prebiotics and Metformin Improve Gut and Hormones in Type 2 Diabetes in Youth (MIGHTY-fiber)
Condition: Diabetes
MeSH terms: Diabetes Mellitus; Diabetes Mellitus, Type 2
Intervention: Biomebliss; Metformin; Placebo
Intervention description: BiomeBliss is a commercially available powder containing prebiotic fiber (inulin and beta glucan), along with blueberry extract providing polyphenols.; 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.; Placebo Comparator
Intervention MeSH terms: Metformin
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Double (Participant, Investigator)
Enrollment: 6.0
Sex: All
Minimum age: 10 Years
Maximum age: 25 Years
Healthy volunteers: No
Keywords: Metformin; Type 2 Diabetes; Youth; Microbiome; Gastrointestinal Side Effects

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...
    

Eligibility criteria:

        -  INCLUSION CRITERIA:

               1. Age 10-25 years

               2. Pubertal or post-pubertal: Girls - Tanner stage IV-V breast; Boys - Testicular
                  volume >10cc

               3. Diagnosis of type 2 diabetes by American Diabetes Association (ADA) guidelines
                  [36] or with established diagnosis previously treated with metformin.

               4. 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.

               5. Hemoglobin A1C <8% at study initiation

        EXCLUSION CRITERIA:

          1. Pregnancy or breastfeeding

          2. Allergy to study medications

          3. Allergy or self-reported intolerance to blueberry, pomegranate, or oats, soy, gluten
             or dairy products.

          4. Chronic insulin therapy or insulin use within the last 3 months

          5. Treatment with other medications which are known to affect the parameters under study,
             including antibiotics within the last month, immunosuppressants, proton-pump
             inhibitors, supraphysiologic systemic steroids, probiotic or prebiotic supplements

          6. Heavy yogurt consumption (2 or more servings of >=6 oz per day)

          7. Chronic GI disease, gastric bypass surgery, cancer diagnosis or autoimmune disease

          8. Metabolic derangement such as metabolic acidosis, severe hyperglycemia (fasting blood
             glucose >= 200mg/dL), and/or liver enzymes > three times the upper limit of normal.

          9. 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.

         10. Body weight >= 450lbs

         11. Body weight <=58kg

         12. Hemoglobin concentration <10g/dL