Alpha-lipoic Acid in Diabetic Patients With Ischemic Cardiomyopathy

NCT ID: NCT06056687

Last Updated: 2024-02-21

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 60 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2023-03-01
• Study Completion Date: 2024-02-01

Brief Summary

The aim of this study is to investigate the effect of alpha-lipoic acid on inflammatory markers and cardiac fibrosis markers in diabetic patients with Ischemic Cardiomyopathy.

Detailed Description

• A 3-month, prospective double blind interventional study, which will include 60 patients with type II Diabetes Mellitus with Ischemic Cardiomyopathy on optimal standard medical therapy, who will be consecutively randomized into two groups, group on ALA 600 mg once daily and the second group on placebo once daily.
• Approval will be obtained from Research and Ethics Committee of Faculty of Pharmacy, Damanhour University. A written informed consent will be obtained from patients before begining of the study.
• All patients will undergo complete physical examination at baseline and after 3 months of treatment.
• Patients will be assessed using Echocardiography before and after the study focusing on:

Left atrial diameter (LAD), basic left ventricular dimensions (EDD and ESD) and both systolic and diastolic function.

-Measurements of inflammatory markers such as [C-reactive protein (CRP), Tumor necrosis factor alpha (TNFα)] and fibrosis markers such as [Transforming growth factor beta (TGFβ), Matrix metalloproteinase 2 (MMP-2)] at the beginning of the study and after 3 months of the study.

Study Outcomes: all patients will be followed up for 3 months for:

• 1ry outcomes: Change in inflammatory and fibrosis markers levels. LV Echocardiography improvements of any of basic Echo parameters.
• 2ry outcomes: Major Adverse Cardiovascular Events (MACE) such as MI, stroke or death. any side effects of the drug. Results The results of the study will be tabulated and statistical tests appropriate to the study will be conducted to evaluate significance of results.

conclusion Conclusion, and recommendations will be given.

Conditions

Ischemic Cardiomyopathy; Diabetes Mellitus

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Study Groups

Alpha Lipoic Acid Group

ALA 600 mg once daily

Group Type: EXPERIMENTAL

Alpha Lipoic Acid 600 MG Oral Tablet

Intervention Type: DRUG

Alpha Lipoic Acid 600 MG Oral Tablet once daily

Placebo Group

the second group on placebo once daily

Group Type: PLACEBO_COMPARATOR

Placebo Tablet

Intervention Type: OTHER

Placebo Tablet once daily

Interventions

Alpha Lipoic Acid 600 MG Oral Tablet

Alpha Lipoic Acid 600 MG Oral Tablet once daily

Intervention Type: DRUG

Placebo Tablet

Placebo Tablet once daily

Intervention Type: OTHER

Other Intervention Names

Thiotacid 600 mg; Placebo

Eligibility Criteria

Inclusion Criteria

• Type 2 diabetes with a history of CAD.
• LV ejection fraction (LVEF) ≤40%.
• Ischemic heart failure patients with NYHA grade II-IV.

Exclusion Criteria

• Type 1 diabetes.
• Severe CKD with GFR ≤ 15 ml/min/1.73m^2.
• Severe liver disease.
• Thyroid disorders.
• Acute febrile illness.
• Autoimmune disorders or connective tissue disorders.

• Minimum Eligible Age: 20 Years
• Maximum Eligible Age: 75 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Damanhour University

OTHER

Sponsor Role: lead

Responsible Party

Rehab Werida

Associate Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Rehab H Werida, Ass Prof.

Role: STUDY_CHAIR

Damanhour University

Noha El bassiouny, Lecturer

Role: STUDY_DIRECTOR

Damanhour University

Locations

Damanhour Teaching Hospital, General Organization for Teaching Hospitals and Institutes.

Damanhūr, Elbehairah, Egypt

Countries

Egypt

Other Identifiers

ALA in Ischemic Cardiomyopathy

Identifier Type: -

Identifier Source: org_study_id