Type1diabetes
Conditions
Keywords
Butyrate
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 7 weeks of treatment and compared to baseline.
Interventions
DRUGBKR-017
BKR-017
Sponsors
Mayo Clinic
BioKier Inc.
Juvenile Diabetes Research Foundation
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Intervention model description
BKR-017: Delayed release butyrate which promotes endogenous incretin secretion to determine if this improves insulin action
Eligibility
Sex/Gender
ALL
Age
20 Years to 80 Years
Healthy volunteers
No
Inclusion criteria
1. Diagnosed with T1D and under the care of a healthcare professional for its management 2. HbA1c 6.4-8.9%, inclusive 3. Has given written informed consent to participate in this study 4. Willing to complete 28-day baseline period and 48 -day test period 5. Willing to maintain current diet and exercise routine for the duration of the study 6. Current use of a Dexcom Continuous Glucose Monitor (CGM)
Exclusion criteria
1. History of bariatric or intestinal surgery 2. Active gastrointestinal disease including but not limited to irritable bowel syndrome, inflammatory bowel disease (e.g., Crohn's disease and ulcerative colitis), diverticulitis, gastroparesis, or chronic/frequent diarrhea or chronic/frequent constipation 3. Active and clinically significant hepatic, pancreatic disease, or renal disease as determined by the investigator 4. History of significant heart disease, including congestive heart failure, prior MI, chronic atrial or ventricular fibrillation, coronary artery disease, cerebral vascular disease, or other cardiovascular disease, that in the opinion of the investigator should exclude the subject from the study 5. Severely uncontrolled hypertension at screening defined as a systolic blood pressure \> 180 mmHg or a diastolic blood pressure \> 110 mmHg on the average of two seated measurements after being at rest for at least 5 minutes 6. Uncontrolled hyperthyroidism or hypothyroidism, or other significant thyroid disease 7. Active significant infection as determined by the investigator 8. Known allergy to butyrate or any of the components of the tablets 9. Participation in a clinical trial and/or treatment with an investigational drug during the 30 days before screening, or within 5 half-lives of receipt of an investigational drug or twice the duration of the biological effect of any investigational drug (whichever is longer) 10. Pregnant, nursing, or trying to become pregnant 11. Presence of pitting edema on physical exam 12. High fiber diet 13. In the investigator's judgment, the subject is not suitable for the study for any other reason or cannot commit to the requirements of the study. 14. Subject is taking one or more of the excluded therapies.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Insulin Sensitivity | Day 0 to Day 48 | Change in Insulin sensitivity as measured by estimated glucose disposal rate (eGDR), a validated clinical tool for estimating insulin sensitivity in Type 1 Diabetes. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Glucose Variability | Day 0 to Day 48 | Change in glucose measured by Hemoglobin A1c (HbA1c) which is a blood test that measures blood glucose levels. |
| Change in Triglycerides | Day 0 to Day 28 | The change in triglycerides levels was measured through blood samples taken at Day 0 and Day 28. |
Countries
United States
Contacts
PRINCIPAL_INVESTIGATORAdrian Vella, MD
Mayo Clinic
Baseline characteristics
| Characteristic | — |
|---|---|
| Age, Categorical <=18 years | 0 Participants |
| Age, Categorical >=65 years | 3 Participants |
| Age, Categorical Between 18 and 65 years | 3 Participants |
| Ethnicity (NIH/OMB) Hispanic or Latino | 0 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 6 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 0 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants |
| Race (NIH/OMB) Asian | 0 Participants |
| Race (NIH/OMB) Black or African American | 0 Participants |
| Race (NIH/OMB) More than one race | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 0 Participants |
| Race (NIH/OMB) White | 6 Participants |
| Region of Enrollment United States | 6 participants |
| Sex: Female, Male Female | 2 Participants |
| Sex: Female, Male Male | 4 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | 0 / 6 |
| other Total, other adverse events | 2 / 6 |
| serious Total, serious adverse events | 0 / 6 |
Outcome results
None listed