Back to resultsButyrate Adjuvant Therapy for Type 1 Diabetes
Primary Purpose
Type1diabetes
Status
Recruiting
Phase
Phase 1
Locations
United States
Study Type
Interventional
Intervention
BKR-017
Sponsored by
About this trial
This is an interventional treatment trial for Type1diabetes focused on measuring Butyrate
Eligibility Criteria
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.
Sites / Locations
- Mayo Clinic in RochesterRecruiting
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Conventional Therapy / Butyrate
Arm Description
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
Outcomes
Primary Outcome Measures
Insulin sensitivity
Change in Insulin sensitivity
Secondary Outcome Measures
Glucose Variability and Triglycerides
Changes in glucose measurements and triglycerides
Full Information
NCT ID
NCT03999853
First Posted
June 25, 2019
Last Updated
October 3, 2023
Sponsor
Mayo Clinic
Collaborators
BioKier Inc., Juvenile Diabetes Research Foundation
1. Study Identification
Unique Protocol Identification Number
NCT03999853
Brief Title
Butyrate Adjuvant Therapy for Type 1 Diabetes
Official Title
Colonic Delivery of Butyrate to Improve Insulin Sensitivity and Lower Triglycerides in Type 1 Diabetes Subjects
Study Type
Interventional
2. Study Status
Record Verification Date
October 2023
Overall Recruitment Status
Recruiting
Study Start Date
July 28, 2022 (Actual)
Primary Completion Date
April 2024 (Anticipated)
Study Completion Date
June 2024 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Mayo Clinic
Collaborators
BioKier Inc., Juvenile Diabetes Research Foundation
4. Oversight
Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes
5. Study Description
Brief 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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Type1diabetes
Keywords
Butyrate
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 1, Phase 2
Interventional Study Model
Single Group Assignment
Model Description
BKR-017: Delayed release butyrate which promotes endogenous incretin secretion to determine if this improves insulin action
Masking
None (Open Label)
Allocation
N/A
Enrollment
20 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Conventional Therapy / Butyrate
Arm Type
Experimental
Arm Description
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
Intervention Type
Drug
Intervention Name(s)
BKR-017
Other Intervention Name(s)
Butyrate tablets
Intervention Description
BKR-017
Primary Outcome Measure Information:
Title
Insulin sensitivity
Description
Change in Insulin sensitivity
Time Frame
(Day 0) to Day 28 and Day 56
Secondary Outcome Measure Information:
Title
Glucose Variability and Triglycerides
Description
Changes in glucose measurements and triglycerides
Time Frame
(Day 0) to Day 28 and Day 56
10. Eligibility
Sex
All
Minimum Age & Unit of Time
20 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Paula Giesler, BSN
Phone
507-255-8345
Email
Giesler.Paula@mayo.edu
First Name & Middle Initial & Last Name or Official Title & Degree
Amy Zipse
Phone
507-255-0907
Email
Zipse.Amy@mayo.edu
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Adrian Vella, MD
Organizational Affiliation
Mayo Clinic
Official's Role
Principal Investigator
Facility Information:
Facility Name
Mayo Clinic in Rochester
City
Rochester
State/Province
Minnesota
ZIP/Postal Code
55905
Country
United States
Individual Site Status
Recruiting
12. IPD Sharing Statement
Links:
URL
https://www.mayo.edu/research/clinical-trials
Description
Mayo Clinic Clinical Trials
Learn more about this trial
Butyrate Adjuvant Therapy for Type 1 Diabetes
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