Clinical trial NCT06056687: Alpha-lipoic Acid in Diabetic Patients With Ischemic Cardiomyopathy
Official title: Effect of Alpha-lipoic Acid on Inflammatory and Cardiac Fibrosis Markers in Diabetic Patients With Ischemic Cardiomyopathy
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Ischemic Cardiomyopathy
Diabetes Mellitus
Lead sponsor: Damanhour University
Sponsor class: OTHER
First posted: 2023-09-28
Enrollment: 60
Sex: ALL
Minimum age (years): 20
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention 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.
Primary purpose: TREATMENT

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.

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.

Primary outcomes:
measure: C-reactive protein (CRP)
timeFrame: 3 month
measure: Tumor necrosis factor alpha (TNFα)]
timeFrame: 3 Months
measure: Transforming growth factor beta (TGFβ)
timeFrame: 3 Months
measure: Matrix metalloproteinase 2 (MMP-2)
timeFrame: 3 Months
Secondary outcomes:
Other outcomes:
Locations:
city: Damanhūr
country: Egypt
facility: Damanhour Teaching Hospital, General Organization for Teaching Hospitals and Institutes.
state: Elbehairah
Study officials:
affiliation: Damanhour University
name: Rehab H Werida, Ass Prof.
role: STUDY_CHAIR
affiliation: Damanhour University
name: Noha El bassiouny, Lecturer
role: STUDY_DIRECTOR
References: