Butyrate Adjuvant Therapy for Type 1 Diabetes

Mayo Clinic6 enrolled

Overview

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.

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 Type

INTERVENTIONAL

Allocation

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

Type1diabetes

Interventions

BKR-017DRUG

BKR-017

Eligibility

Sex: ALLMin age: 20 YearsMax age: 80 Years

Medical Language ↔ Plain English

Inclusion Criteria: 1. 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; 2. Will also meet HbA1c level of 6.4-8.9% and BMI of \< 30 kg/m2 at week -4. Exclusion Criteria: 1. Except for the use of insulin, no other treatments for T1D will be permitted. 2. Pregnancy 3. Inability or unwillingness of individual or legal guardian/representative to give written informed consent.

Locations (1)

Mayo Clinic in Rochester

Rochester, Minnesota, United States

Outcomes

Primary Outcomes

Insulin sensitivity

Change in Insulin sensitivity

Time frame: (Day 0) to Day 28 and Day 56

Secondary Outcomes

Glucose Variability and Triglycerides

Changes in glucose measurements and triglycerides

Time frame: (Day 0) to Day 28 and Day 56

Data from ClinicalTrials.gov

This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.