CompletedPhase 1/2

Butyrate Adjuvant Therapy for Type 1 Diabetes

United States6 participantsStarted 2022-07-28

Plain-language summary

The investigators are interested to evaluate the effect of BKR-017 (colon-targeted 500 mg butyrate tablets) as adjuvant therapy on metabolic control in type 1 diabetes (TID) subjects.

Who can participate

Age range20 Years – 80 Years

SexALL

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Inclusion criteria

✓. Diagnosed with T1D and under the care of a healthcare professional for its management
✓. HbA1c 6.4-8.9%, inclusive
✓. Has given written informed consent to participate in this study
✓. Willing to complete 28-day baseline period and 48 -day test period
✓. Willing to maintain current diet and exercise routine for the duration of the study
✓. Current use of a Dexcom Continuous Glucose Monitor (CGM)

Exclusion criteria

✕. History of bariatric or intestinal surgery
✕. Active gastrointestinal disease including but not limited to irritable bowel syndrome, inflammatory bowel disease (e.g., Crohn's disease and ulcerative colitis), diverticulitis, gastroparesis, or chronic/frequent diarrhea or chronic/frequent constipation
✕. Active and clinically significant hepatic, pancreatic disease, or renal disease as determined by the investigator
✕. History of significant heart disease, including congestive heart failure, prior MI, chronic atrial or ventricular fibrillation, coronary artery disease, cerebral vascular disease, or other cardiovascular disease, that in the opinion of the investigator should exclude the subject from the study
✕. Severely uncontrolled hypertension at screening defined as a systolic blood pressure \> 180 mmHg or a diastolic blood pressure \> 110 mmHg on the average of two seated measurements after being at rest for at least 5 minutes
✕. Uncontrolled hyperthyroidism or hypothyroidism, or other significant thyroid disease
✕. Active significant infection as determined by the investigator
✕. Known allergy to butyrate or any of the components of the tablets

What they're measuring

Insulin Sensitivity

Timeframe: Day 0 to Day 48

Trial details

NCT IDNCT03999853

SponsorMayo Clinic

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2025-04-01

Results submitted2026-02-20

View on ClinicalTrials.gov More Type1diabetes trials