Butyrate Adjuvant Therapy for Type 1 Diabetes

Type1diabetes Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03999853
• Other study ID #: 19-006035
• Status: Recruiting
• Phase: Phase 1/Phase 2
• Start date: July 28, 2022
• Est. completion date: January 2025

Study information

• Verified date: May 2024
• Source: Mayo Clinic
• Contact: Paula Giesler, BSN
• Phone: 507-255-8345
• Email: Giesler.Paula[@]mayo.edu
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 20
• Est. completion date: January 2025
• Est. primary completion date: October 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 20 Years to 80 Years

Eligibility

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.

Related Conditions & MeSH terms

• Diabetes Mellitus
• Diabetes Mellitus, Type 1
• Type1diabetes

Intervention

Drug:
• BKR-017
BKR-017

Locations

Country	Name	City	State
United States	Mayo Clinic in Rochester	Rochester	Minnesota

Sponsors (3)

Lead Sponsor	Collaborator
Mayo Clinic	BioKier Inc., Juvenile Diabetes Research Foundation

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Insulin sensitivity	Change in Insulin sensitivity	(Day 0) to Day 28 and Day 56
Secondary	Glucose Variability and Triglycerides	Changes in glucose measurements and triglycerides	(Day 0) to Day 28 and Day 56