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Dietary Supplement

Probiotics for Diabetic Cardiomyopathy and Heart Failure

N/A

Waitlist Available

Research Sponsored by Mahavir Singh, DVM, MS, PhD

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Diabetic subjects with high blood glucose levels

Be older than 18 years old

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 4 years

Awards & highlights

Study Summary

This trial will show that ketone bodies can help Type 1 Diabetes patients and prevent cardiac problems that may arise from the condition.

Who is the study for?

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.Check my eligibility

What is being tested?

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.See study design

What are the potential side effects?

While specific side effects aren't listed, probiotics generally may cause digestive discomfort such as gas or bloating, especially when first starting them. They're usually considered safe but can pose risks for those with weakened immune systems.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

Select...

I am diabetic with high blood sugar levels.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 4 years

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~4 years

This trial's timeline: 3 weeks for screening, Varies for treatment, and 4 years for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Measure-I

Measure-II

Secondary outcome measures

Measure-I

Trial Design

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)

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Probiotic

2013

Completed Phase 4

~3570

0 / 1Eligibility criteria met

Find a Location

Who is running the clinical trial?

Mahavir Singh, DVM, MS, PhDLead Sponsor

National Institutes of Health (NIH)NIH

2,696 Previous Clinical Trials

6,952,539 Total Patients Enrolled

4 Trials studying Cardiomyopathy

1,505 Patients Enrolled for Cardiomyopathy

Media Library

Probiotic (Dietary Supplement) Clinical Trial Eligibility Overview. Trial Name: NCT05571865 — N/A

Cardiomyopathy Research Study Groups: Control subjects (non-diabetic)., Diabetic Subjects

Cardiomyopathy Clinical Trial 2023: Probiotic Highlights & Side Effects. Trial Name: NCT05571865 — N/A

Probiotic (Dietary Supplement) 2023 Treatment Timeline for Medical Study. Trial Name: NCT05571865 — N/A

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Does the trial enrollment accept individuals below fifty-five years of age?

"This trial is looking for patients over the age of consent and below 70 years old."

Answered by AI

Are there still opportunities to participate in this research endeavor?

"Verifying the information on clinicaltrials.gov, it appears that this medical study is not accepting new candidates at present. Initially posted on July 1st 2023 and last updated October 5th 2022, there are presently 830 more trials actively seeking applicants instead."

Answered by AI

Am I eligible to join the research study?

"This research is currently enrolling 40 individuals with diabetic cardiomyopathy aged 18 to 70. Furthermore, interested parties must meet the following prerequisites: having a history of elevated blood sugar levels."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

Diabetic Cardiomyopathy and Heart Failure

Mahavir Singh, DVM, MS, PhD 2023. "Diabetic Cardiomyopathy and Heart Failure". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT05571865.

All > Cardiomyopathy