Colonic Delivery of Butyrate to Improve Insulin Sensitivity and Lower Triglycerides in Type 1 Diabetes Subjects
Trial Snapshot
- Phase
- Phase 1
- Status
- Completed
- Sponsor
- Mayo Clinic
- Enrollment
- 6
- Locations
- 1
- Primary Endpoint
- Insulin sensitivity
Study Overview
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.
Study Design
- Study Type
- Interventional
- Allocation
- Na
- Intervention Model
- Single Group
- Primary Purpose
- Treatment
- Masking
- None
Eligibility Criteria
- Ages
- 20 Years to 80 Years (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
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.
- •Inability or unwillingness of individual or legal guardian/representative to give written informed consent.
Arms & Interventions
Conventional Therapy / Butyrate
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
Intervention: BKR-017 (Drug)
Outcomes
Primary Outcomes
Insulin sensitivity
Time Frame: (Day 0) to Day 28 and Day 56
Change in Insulin sensitivity
Secondary Outcomes
- Glucose Variability and Triglycerides((Day 0) to Day 28 and Day 56)
Investigators
Adrian Vella
Consultant
Mayo Clinic