Protocol Details
Prebiotics and Metformin Influences Gut and Hormones in Type 2 Diabetes Youth
This study is NOT currently recruiting participants.
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 Years
Max Age: 25 Years |
Referral Letter Required |
No |
Population Exclusion(s) |
Fetuses;
Adults who are or may become unable to consent;
Pregnant Women |
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
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
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.
Contacts:
Clinical Trials Number:
NCT04209075