Colonic Delivery of Butyrate to Improve Insulin Sensitivity and Lower Triglycerides in Type 1 Diabetes Subjects

  • STATUS
    Recruiting
  • End date
    Sep 21, 2023
  • participants needed
    20
  • sponsor
    Mayo Clinic
Updated on 21 October 2022

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.

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.

Details
Condition Type1diabetes
Treatment Usual Care, BKR-017
Clinical Study IdentifierNCT03999853
SponsorMayo Clinic
Last Modified on21 October 2022

Eligibility

Yes No Not Sure

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
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