Prebiotics in Patients With Type 1 Diabetes (NCT04963777)
Effect of Prebiotic Fibre on Glycemic Control, Gut Microbiota, and Intestinal Permeability in Type 1 Diabetes
๐ฉบ Plain-English Summary (8th-Grade Level)
Evidence suggests that prebiotic fibre can correct dysbiosis, reduce intestinal permeability and improve glycemic control. The investigators hypothesize that microbial changes induced by prebiotics contribute to gut and endocrine adaptations that reduce glucose fluctuations, including less hyper- and hypoglycemia in type 1 diabetes (T1D). The primary objective is to compare the change in frequency of hypoglycemia from baseline to 6 months in n=144 individuals with T1D treated with a 6-month course of prebiotic or placebo as an adjunct to insulin. Secondary objectives will be aimed at understanding the mechanisms by which the prebiotics could affect glycemic control.
Who can join: Review the eligibility criteria below.
Location: University of Calgary โ Calgary, Alberta
Age range: 7 Years
๐งช Interventions in This Study
๐ "Do I Qualify?" โ 1-Minute Self Screener
Instant ChecklistFull eligibility criteria are available on the official NIH protocol. View the criteria โ
๐ All Participating Trial Locations (3 Sites)
- University of Calgary โ Calgary, Alberta
- University of Alberta โ Edmonton, Alberta
- University of Saskatchewan โ Saskatoon, Saskatchewan
๐ Contact the Study Coordinator
Phone: (403) 220-8218
Email: reimer@ucalgary.ca
Coordinator details come directly from the registered NIH protocol. Confirm the study is still recruiting before traveling.
๐ฐ Cost, Insurance & Patient Rights
- 100% Free Items: The investigational treatment and protocol-required procedures are supplied at zero cost by the sponsor.
- Routine Patient Care: Under federal law (ACA ยง 2709) and many state statutes, routine care costs are covered during participation.
- Voluntary Participation: You may withdraw at any time without affecting your standard medical care.
More studies in Type 1 Diabetes
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- Remedy to Diabetes Distress (R2D2): A Scalable Screen to Treat Program for School-age Families โ Jacksonville, Florida
- Diabetes Inspired Culinary Education (DICE): Culinary Medicine Intervention for At-Risk Youth With Type 1 Diabetes โ Cleveland, Ohio
- GO TEAM: Glucose Optimization Through Technology Assisted Management โ Cleveland, Ohio
- REAL-Fam Feasibility Study for Youth Diabetes Management โ Chapel Hill, North Carolina
- Reducing Diabetes Distress Using Cognitive Behavioral Therapy in Young Adults With Type 1 Diabetes โ New York, New York
Explore by condition: All Type 1 Diabetes clinical trials
๐ก How to Participate
- Check the checklist above to see if you may qualify.
- Contact the study coordinator using the phone/email above.
- Ask about the visit schedule, what is covered at no cost, and any travel support.
- Confirm with your own doctor before making a decision.