Butyrate Therapy for Type 1 Diabetes

Recruiting in Palo Alto (17 mi)

Overseen ByAdrian Vella, MD

Age: 18+

Sex: Any

Travel: May be covered

Time Reimbursement: Varies

Trial Phase: Phase 1 & 2

Waitlist Available

Sponsor: Mayo Clinic

Stay on your current meds

No Placebo Group

Trial Summary

What is the purpose of this trial?This trial is testing a new tablet called BKR-017, which delivers butyrate to the colon, in people with type 1 diabetes. The goal is to see if it helps improve blood sugar control and reduce triglycerides over a few months.

Eligibility Criteria

This trial is for adults aged 20-80 with Type 1 Diabetes, who are patients at the Mayo Clinic Endocrinology Clinic. They must have an HbA1c level of 6.4-8.9%, a BMI under 30, and low C-Peptide levels (<0.5 ng/mL). Participants cannot be on any T1D treatments other than insulin and must not be pregnant or unable to consent.

Inclusion Criteria

I am between 20 and 80 years old with type 1 diabetes and a C-Peptide level below 0.5 ng/mL.

My HbA1c is between 6.4-8.9% and my BMI is under 30.

Exclusion Criteria

I only use insulin to manage my Type 1 Diabetes.

Participant Groups

The trial is testing BKR-017, which are butyrate tablets aimed at the colon, as an additional treatment to improve metabolic control in people with Type 1 Diabetes.

1Treatment groups

Experimental Treatment

Group I: Conventional Therapy / ButyrateExperimental Treatment1 Intervention

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