Diabetic Cardiomyopathy and Heart Failure

NCT05571865 | Withdrawn DMC

• 2 other identifiers: 00002PA-20-190
• Study Type: interventional
• Target: N/A
• Locations: 1 country
• Sites: 1

Brief Summary

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).

Conditions

Diabetic Cardiomyopathies; Heart Failure

Keywords

Diabetic Cardiomyopathy, Metabolic Dysregulation, and Heart Failure.

Outcome Measures

Primary Outcomes (2)

• Primary Outcome Measure-I

  Levels of glucose in blood and urine

  4 years

• Primary Outcome Measure-II

  Cardiac function evaluation by electrocardiogram

  4 years

Secondary Outcomes (1)

• Secondary Outcome Measure-I

  4 years

Study Arms (2)

Control subjects (non-diabetic).

OTHER

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

Dietary Supplement: Probiotic

Diabetic Subjects

OTHER

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

Dietary Supplement: Probiotic

Interventions

Probiotic DIETARY_SUPPLEMENT

Oral administration of a probiotic

Control subjects (non-diabetic).; Diabetic Subjects

Eligibility Criteria

• Age: 18 Years - 70 Years
• Gender Eligibility Details: Both male and female representing race/ethnicity
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Diabetic subjects with high blood glucose levels

You may not qualify if:

• \- Comorbidities affecting glucose levels and cardiac function

Sponsors & Collaborators

• University of Louisville: lead
• National Institutes of Health (NIH): collaborator

Study Sites (1)

University of Louisville School of Medicine

Louisville, Kentucky, 40202, United States

Location

Related Publications (2)

• 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):67. doi: 10.3390/microorganisms7030067.

  PMID: 30832381 RESULT

• 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 Inflammatory Cytokines in Patients With Type 1 Diabetes Mellitus. Front Endocrinol (Lausanne). 2022 Mar 1;13:754401. doi: 10.3389/fendo.2022.754401. eCollection 2022.

  PMID: 35299968 RESULT

MeSH Terms

Conditions

Diabetic Cardiomyopathies; Heart Failure

Interventions

Probiotics

Condition Hierarchy (Ancestors)

Cardiomyopathies; Heart Diseases; Cardiovascular Diseases; Diabetes Complications; Diabetes Mellitus; Endocrine System Diseases

Intervention Hierarchy (Ancestors)

Dietary Supplements; Food; Diet, Food, and Nutrition; Physiological Phenomena; Food and Beverages

Study Officials

• Mahavir Singh, DVM, MS, PhD

  University of Louisville School of Medicine

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Diabetic, and non-diabetic subjects.

Study Record Dates

• First Submitted: September 16, 2022
• First Posted: October 7, 2022
• Study Start: July 1, 2025
• Primary Completion (Estimated): June 1, 2026
• Study Completion (Estimated): June 1, 2026
• Last Updated: January 31, 2025

Record last verified: 2025-01

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF, CSR, ANALYTIC CODE
• Time Frame: As soon as the data is collected, and fully analyzed.
• Access Criteria: Via personal meetings, national and international conferences.

Locations

US (1)