Butyrate Adjuvant Therapy for Type 1 Diabetes
- Registration Number
- NCT03999853
- Lead Sponsor
- Mayo Clinic
- Brief 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.
- Detailed Description
This study will test effect of BKR-017 (colon-targeted 500 mg butyrate tablets) as adjuvant therapy in type 1 diabetes (TID) Subjects on metabolic control in this population. Insulin sensitivity, glucose control (variability) and triglycerides will be measured after 8 weeks of treatment and compared to baseline.
Recruitment & Eligibility
- Status
- ACTIVE_NOT_RECRUITING
- Sex
- All
- Target Recruitment
- 20
Inclusion Criteria
- All type 1 diabetes with C-Peptide (CPR) less than 0.5 ng/mL subjects who are > 20 and <80 years of age recruited from the Mayo Clinic Endocrinology Clinic;
- Will also meet HbA1c level of 6.4-8.9% and BMI of < 30 kg/m2 at week -4.
Exclusion Criteria
- Except for the use of insulin, no other treatments for T1D will be permitted.
- Pregnancy
- Inability or unwillingness of individual or legal guardian/representative to give written informed consent.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description Conventional Therapy / Butyrate BKR-017 Subjects will be receiving usual therapy for the first study period (approx 1 month) then 500 mg Butyrate tablets to be taken at a dose of 1.5 g (3 tablets) twice daily (BID) for approx 2 months
- Primary Outcome Measures
Name Time Method Insulin sensitivity (Day 0) to Day 28 and Day 56 Change in Insulin sensitivity
- Secondary Outcome Measures
Name Time Method Glucose Variability and Triglycerides (Day 0) to Day 28 and Day 56 Changes in glucose measurements and triglycerides
Trial Locations
- Locations (1)
Mayo Clinic in Rochester
🇺🇸Rochester, Minnesota, United States