Overview

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

Status:
Completed

Trial end date:
2021-07-15

Target enrollment:
0

Participant gender:
All

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...

Phase:

Phase 2

Accepts Healthy Volunteers?

Details

Lead Sponsor:

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

Treatments:

Hormones
Metformin

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