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Protocol Details

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

This study is NOT currently recruiting participants.

Summary | Eligibility | Citations | Contacts

Summary

Number

20-DK-0018

Sponsoring Institute

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

Recruitment Detail

Type: Completed Study; data analyses ongoing
Gender: Male & Female
Min Age: 10
Max Age: 25

Referral Letter Required

No

Population Exclusion(s)

Adults who are or may become unable to consent;
Pregnant Women and Fetuses

Special Instructions

Currently Not Provided

Keywords

Metformin;
Type 2 Diabetes;
Youth;
Microbiome;
Gastrointestinal Side Effects

Recruitment Keyword(s)

None

Condition(s)

Diabetes

Investigational Drug(s)

None

Investigational Device(s)

None

Intervention(s)

Dietary Supplement: Biomebliss
Drug: Metformin
Dietary Supplement: Placebo

Supporting Site

National Institute of Diabetes and Digestive and Kidney Diseases

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.

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

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Eligibility

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 ADA guidelines [36] or with established diagnosis previously treated with metformin.

4. Negative test for diabetes-related autoantibodies (glutamic acid decarboxylase 65 and tyrosine phosphataserelated 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


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Citations:

Burton JH, Johnson M, Johnson J, Hsia DS, Greenway FL, Heiman ML. Addition of a Gastrointestinal Microbiome Modulator to Metformin Improves Metformin Tolerance and Fasting Glucose Levels. J Diabetes Sci Technol. 2015 Jul;9(4):808-14. doi: 10.1177/1932296815577425. Epub 2015 Mar 23.

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Contacts:

Principal Investigator

Referral Contact

For more information:

Stephanie T. Chung, M.D.
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)



Lilian S. Mabundo
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
National Institutes of Health
Building 10
Room 5-5750
10 Center Drive
Bethesda, Maryland 20892
(240) 383-9379
lilian.mabundo@nih.gov

Office of Patient Recruitment
National Institutes of Health Clinical Center (CC)
Building 61, 10 Cloister Court
Bethesda, Maryland 20892
Toll Free: 1-800-411-1222
Local Phone: 301-451-4383
TTY: 1-866-411-1010
PRPL@cc.nih.gov

Clinical Trials Number:

NCT04209075

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