Alpha-lipoic Acid in Diabetic Patients With Ischemic Cardiomyopathy

Not Applicable

Completed

• Conditions: Diabetes Mellitus; Ischemic Cardiomyopathy
• Interventions: Other: Placebo Tablet; Drug: Alpha Lipoic Acid 600 MG Oral Tablet

• Registration Number: NCT06056687
• Lead Sponsor: Damanhour University

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.

Study Timeline

• Study Start: 2023-03-01
• Study First Submitted: 2023-09-21
• Study First Submitted QC: 2023-09-21
• Study First Posted: 2023-09-28
• Primary Completion: 2024-01-31
• Status Verified: 2024-02
• Study Completion: 2024-02-01
• Last Update Submitted: 2024-02-19
• Last Update Posted: 2024-02-21

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 60

Inclusion Criteria

Not provided

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Exclusion Criteria

Not provided

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Placebo Group	Placebo Tablet	the second group on placebo once daily
Alpha Lipoic Acid Group	Alpha Lipoic Acid 600 MG Oral Tablet	ALA 600 mg once daily

Primary Outcome Measures

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

Trial Locations

Locations (1)

Damanhour Teaching Hospital, General Organization for Teaching Hospitals and Institutes.; 🇪🇬 Damanhūr, Elbehairah, Egypt