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Clinical trial

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

ID
Name
ALA in Ischemic Cardiomyopathy
Description
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.
Trial arms
Trial start
2023-03-01
Estimated PCD
2024-01-31
Trial end
2024-02-01
Status
Completed
Treatment
Alpha Lipoic Acid 600 MG Oral Tablet
Alpha Lipoic Acid 600 MG Oral Tablet once daily
Arms:
Alpha Lipoic Acid Group
Other names:
Thiotacid 600 mg
Placebo Tablet
Placebo Tablet once daily
Arms:
Placebo Group
Other names:
Placebo
Size
60
Primary endpoint
C-reactive protein (CRP)
3 month
Tumor necrosis factor alpha (TNFα)]
3 Months
Transforming growth factor beta (TGFβ)
3 Months
Matrix metalloproteinase 2 (MMP-2)
3 Months
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.
Protocol
{'studyType': 'INTERVENTIONAL', 'phases': ['NA'], 'designInfo': {'allocation': 'RANDOMIZED', 'interventionModel': 'PARALLEL', 'interventionModelDescription': '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.', 'primaryPurpose': 'TREATMENT', 'maskingInfo': {'masking': 'DOUBLE', 'maskingDescription': 'Double Blind', 'whoMasked': ['PARTICIPANT', 'INVESTIGATOR']}}, 'enrollmentInfo': {'count': 60, 'type': 'ACTUAL'}}
Updated at
2024-02-21

1 organization

1 product

2 indications

Organization
Damanhour University
Product
Alpha Lipoic Acid
Indication
Ischemic Cardiomyopathy
Indication
Diabetes Mellitus