Probiotics for Diabetic Cardiomyopathy and Heart Failure

Overseen By Mahavir Singh, DVM, MS, PhD

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: University of Louisville

Disqualifiers: Glucose, Cardiac, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Approved in 3 Jurisdictions This treatment is already approved in other countries

Compensation: Varies

Number of Visits: Unknown

Duration: 4 years

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

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.

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive either a placebo or probiotic intervention to assess the effects of ketone bodies on diabetic cardiomyopathy

4 years

Follow-up

Participants are monitored for safety and effectiveness after treatment, including biochemical estimation of biomarkers and cardiac function evaluation

4 weeks

Treatment Details

Interventions

• Probiotic

Trial Overview The 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

Group I: Diabetic Subjects Experimental Treatment 1 Intervention

Diabetic subjects: 10 subjects: No intervention (placebo). 10 subjects: Intervention (probiotic)

Group II: Control subjects (non-diabetic). Experimental Treatment 1 Intervention

Control subjects (non-diabetic): 10 subjects: No intervention (placebo). 10 subjects: Intervention (probiotic)

Probiotic is already approved in European Union, United States, Canada for the following indications:

Approved in European Union as Probiotics for:

• Supports gut health
• Reduces symptoms of irritable bowel syndrome (IBS)
• Supports immune system

Approved in United States as Probiotics for:

• Supports gut health
• Reduces symptoms of irritable bowel syndrome (IBS)
• Supports immune system

Approved in Canada as Probiotics for:

• Supports gut health
• Reduces symptoms of irritable bowel syndrome (IBS)
• Supports immune system

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+