Alpha-lipoic Acid in Diabetic Patients With Ischemic Cardiomyopathy

Study Overview
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Brief Summary
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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
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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.

Official Title
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Effect of Alpha-lipoic Acid on Inflammatory and Cardiac Fibrosis Markers in Diabetic Patients With Ischemic Cardiomyopathy

Conditions
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Ischemic Cardiomyopathy, Diabetes Mellitus

Intervention / Treatment
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* Drug: Alpha Lipoic Acid 600 MG Oral Tablet
* Other: Placebo Tablet


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 20 Years
Maximum Age: 75 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: 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.
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Alpha Lipoic Acid Group<br>ALA 600 mg once daily | Drug: Alpha Lipoic Acid 600 MG Oral Tablet<br>* Alpha Lipoic Acid 600 MG Oral Tablet once daily<br>* Other names: Thiotacid 600 mg;|
| Placebo Comparator: Placebo Group<br>the second group on placebo once daily | Other: Placebo Tablet<br>* Placebo Tablet once daily<br>* Other names: Placebo;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| C-reactive protein (CRP) | Serum Biomarker (mg/ml) | 3 month | 
| Tumor necrosis factor alpha (TNFα)] | Serum Biomarker (pg/ml) | 3 Months | 
| Transforming growth factor beta (TGFβ) | fibrosis markers (ng/ml) | 3 Months | 
| Matrix metalloproteinase 2 (MMP-2) | fibrosis markers (ng/ml) | 3 Months |