Trial Summary
What is the purpose of this trial?
This study will demonstrate the beneficial effects of ketone bodies in type 1 diabetes (T1D) patients and will have significant translational applications to prevent serious metabolic conditions such as T1D induced diabetic cardiomyopathy (DCM).
Research Team
MS
Mahavir Singh, DVM, MS, PhD
Principal Investigator
University of Louisville School of Medicine
Eligibility Criteria
This trial is for people with type 1 diabetes who have high blood sugar levels and are at risk of developing heart problems like diabetic cardiomyopathy (DCM) and heart failure. It's not suitable for those with other health conditions that could affect their blood sugar or heart function.Inclusion Criteria
I am diabetic with high blood sugar levels.
Exclusion Criteria
I have health conditions that affect my blood sugar and heart.
Treatment Details
Interventions
- Probiotic (Dietary Supplement)
Trial OverviewThe study is testing the effects of a probiotic on preventing serious metabolic issues in type 1 diabetes, particularly focusing on how it might help avoid diabetic cardiomyopathy, which affects the heart muscle.
Participant Groups
2Treatment groups
Experimental Treatment
Group I: Diabetic SubjectsExperimental Treatment1 Intervention
Diabetic subjects:
10 subjects: No intervention (placebo). 10 subjects: Intervention (probiotic)
Group II: Control subjects (non-diabetic).Experimental Treatment1 Intervention
Control subjects (non-diabetic):
10 subjects: No intervention (placebo). 10 subjects: Intervention (probiotic)
Probiotic is already approved in Canada for the following indications:
Approved in Canada as Probiotics for:
- Supports gut health
- Reduces symptoms of irritable bowel syndrome (IBS)
- Supports immune system
Find a Clinic Near You
Who Is Running the Clinical Trial?
University of Louisville
Lead Sponsor
Trials
353
Recruited
76,400+
Mahavir Singh, DVM, MS, PhD
Lead Sponsor
Trials
1
National Institutes of Health (NIH)
Collaborator
Trials
2,896
Recruited
8,053,000+