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Patient Recruitment

NIDDK Research of Prebiotic Fiber Supplements With Metformin in Youths With Type 2 Diabetes

"Mighty Fiber"— the Power of Prebiotics on Metformin Therapy in Type 2 Diabetics

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Metformin related gastro-intestinal (GI) side effects (bloating, diarrhea, cramping, nausea and vomiting) are common barriers to treatment in youths with type 2 diabetes, in whom there are no other oral FDA approved alternative. Therefore, identifying ways to reduce these GI side effects, especially in youths with type 2 diabetes, is of high clinical significance. Researchers at the National Institutes of Health National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK), want to do just that. They need your help in testing if prebiotic fiber supplements– containing prebiotic fibers and polyphenols – will reduce GI side effects of metformin.

Access to expert physicians, procedures, and study related drugs are at no cost; Compensation also provided.

Study Involves:

  • 2 phases and 6 outpatient visits at the NIH Clinical Center over the course of 10 weeks
    • Phase 1: A 5-week randomized double-blind cross-over trial with two 1-week intervention periods
      (metformin + prebiotic and metformin + placebo)
    • Phase 2: Immediately following phase 1 in which all participants will start an open-label 4-week
      intervention with metformin and the prebiotic MM
  • Blood and stool collections, questionnaires, blood glucose monitoring with state of the art device, activity and sleep monitoring with a small wrist device, body mass composition and food record

You may participate:

  • If you are 10 to 25 years of age
  • If you are diagnosed with type 2 diabetes, and not on insulin therapy
  • With the consent of a parent, guardian, or legally authorized representative if under 18 years of age

The NIH Clinical Center, America's Research Hospital, is located in Bethesda, Maryland, on the Metro Red line (Medical Center stop).

For more information:
NIH Clinical Center
Office of Patient Recruitment
800-411-1222 (TTY: 800-877-8339)
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Email: PRPL@cc.nih.gov

Or go online:
https://go.usa.gov/xdJ6k
Refer to NIH study # 20-DK-0018

Department of Health and Human Services
National Institutes of Health Clinical Center (CC)
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)

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This page last updated on 10/22/2021

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