Heart Failure Clinical Trial
Official title:
Preventing Diabetic Cardiomyopathy and Heart Failure by Ketone Bodies
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).
Status | Not yet recruiting |
Enrollment | 40 |
Est. completion date | June 2026 |
Est. primary completion date | June 2026 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | All |
Age group | 18 Years to 70 Years |
Eligibility | Inclusion Criteria: -Diabetic subjects with high blood glucose levels Exclusion Criteria: - Comorbidities affecting glucose levels and cardiac function |
Country | Name | City | State |
---|---|---|---|
United States | University of Louisville School of Medicine | Louisville | Kentucky |
Lead Sponsor | Collaborator |
---|---|
Mahavir Singh, DVM, MS, PhD | National Institutes of Health (NIH) |
United States,
Mishra SP, Wang S, Nagpal R, Miller B, Singh R, Taraphder S, Yadav H. Probiotics and Prebiotics for the Amelioration of Type 1 Diabetes: Present and Future Perspectives. Microorganisms. 2019 Mar 2;7(3). pii: E67. doi: 10.3390/microorganisms7030067. Review — View Citation
Wang CH, Yen HR, Lu WL, Ho HH, Lin WY, Kuo YW, Huang YY, Tsai SY, Lin HC. Adjuvant Probiotics of Lactobacillus salivarius subsp. salicinius AP-32, L. johnsonii MH-68, and Bifidobacterium animalis subsp. lactis CP-9 Attenuate Glycemic Levels and Inflammato — View Citation
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Primary Outcome Measure-I | Levels of glucose in blood and urine | 4 years | |
Primary | Primary Outcome Measure-II | Cardiac function evaluation by electrocardiogram | 4 years | |
Secondary | Secondary Outcome Measure-I | Biochemical estimation of biomarkers from blood samples | 4 years |
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