NCT03999853CompletedPhase 1/2
Butyrate Adjuvant Therapy for Type 1 Diabetes
Colonic Delivery of Butyrate to Improve Insulin Sensitivity and Lower Triglycerides in Type 1 Diabetes Subjects
Source: ClinicalTrials.gov · Last updated 31 Mar 2026
Brief summary (registry, in English)
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.
- Status (registry)
- Completed
- Phase (registry)
- Phase 1/2
- Study type
- Interventional
- Enrollment
- 6 (actual)
- First submitted
- 25 Jun 2019
- Start date
- 28 Jul 2022
- Primary completion date
- 1 Apr 2025
- Lead sponsor
- Mayo Clinic
- Diseases
- Type 1 diabetes
- NCT number
- NCT03999853
What you commit to
- Study type: Interventional · Phase 1/2
- Participants enrolled: 6
- From 28 Jul 2022 to the primary completion date, 1 Apr 2025
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- 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
- Participation in a clinical trial and/or treatment with an investigational drug during the 30 days before screening, or within 5 half-lives of receipt of an investigational drug or twice the duration of the biological effect of any investigational drug (whichever is longer)
- Subject is taking one or more of the excluded therapies.
Other illness
- 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
- 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
Other
- Pregnant, nursing, or trying to become pregnant
- Presence of pitting edema on physical exam
- High fiber diet
- In the investigator's judgment, the subject is not suitable for the study for any other reason or cannot commit to the requirements of the study.
Who the study is looking for
- 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)
Age in the registry: 20 years to 80 years · Sex: All · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Mayo Clinic in Rochester Coordinator of this site? Confirm its status | Rochester | United States | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.