Alpha-lipoic Acid in Diabetic Patients With Ischemic Cardiomyopathy

Damanhour University

Status: Completed

Conditions: Diabetes Mellitus; Ischemic Cardiomyopathy

Treatments: Other: Placebo Tablet; Drug: Alpha Lipoic Acid 600 MG Oral Tablet

Study type: Interventional

Funder types: Other

Identifiers

NCT06056687

ALA in Ischemic Cardiomyopathy

Details and patient eligibility

About

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.

Full 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.

Enrollment: 60 patients

Sex: All

Ages: 20 to 75 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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60 participants in 2 patient groups, including a placebo group

Alpha Lipoic Acid Group

Experimental group

Description:

ALA 600 mg once daily

Treatment:

Drug: Alpha Lipoic Acid 600 MG Oral Tablet

Placebo Group

Placebo Comparator group

Description:

the second group on placebo once daily

Treatment:

Other: Placebo Tablet