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Butyrate Adjuvant Therapy for Type 1 Diabetes | Clinical Trials | Clareo Health

COMPLETEDPHASE1/PHASE2

Butyrate Adjuvant Therapy for Type 1 Diabetes

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

NCT03999853•Mayo Clinic

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.

Eligibility

Age

20 - 80 years

Sex

ALL

Healthy Volunteers

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

Key Dates

Start Date

July 28, 2022

Primary Completion Date

April 1, 2025

Completion Date

December 1, 2025

Last Updated

January 7, 2026

Enrollment

ACTUAL participants

Conditions

Type1diabetes

Interventions

BKR-017

DRUG

Crosstalk Between Mucosal-Associated Invariant T (MAIT) Cells and the Gut Microbiota and Mucosa in the Development of Type 1 Diabetes in Children

NCT05054361

Type1diabetes

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RECRUITINGPHASE1

Continuous Ketone Monitoring in People With Type 1 Diabetes Using SGLT2 Inhibitors

NCT06753994

DiabetesType1diabetes+1 more

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: January 7, 2026Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

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Butyrate Adjuvant Therapy for Type 1 Diabetes

Inclusion Criteria

Exclusion Criteria

Crosstalk Between Mucosal-Associated Invariant T (MAIT) Cells and the Gut Microbiota and Mucosa in the Development of Type 1 Diabetes in Children

Continuous Ketone Monitoring in People With Type 1 Diabetes Using SGLT2 Inhibitors

Mesenchymal Stromal Cells to Treat Type 1 Diabetes in Children and Adolescents

Screening for Islet Autoantibodies in the Israeli Paediatric General Population for Detection of Pre-symptomatic Type-1 Diabetes Mellitus

Effect of Fasting on Hypoglycemic Counterregulation in Type 1 Diabetes

Advanced Glycation Products and Vascular Complications in Type 1 Diabetes