Alpha-lipoic Acid in Diabetic Patients With Ischemic Cardiomyopathy

February 19, 2024 updated by: Rehab Werida, Damanhour University

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Actual)

60

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Egypt
    • Elbehairah
      • Damanhūr, Elbehairah, Egypt, 31527
        • Damanhour Teaching Hospital, General Organization for Teaching Hospitals and Institutes.

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Alpha Lipoic Acid Group
ALA 600 mg once daily
Drug: Alpha Lipoic Acid 600 MG Oral Tablet
Alpha Lipoic Acid 600 MG Oral Tablet once daily
Other Names:
  • Thiotacid 600 mg
Placebo Comparator: Placebo Group
the second group on placebo once daily
Other: Placebo Tablet
Placebo Tablet once daily
Other Names:
  • Placebo

What is the study measuring?

Primary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Damanhour University

Investigators

  • Study Chair: Rehab H Werida, Ass Prof., Damanhour University
  • Study Director: Noha El bassiouny, Lecturer, Damanhour University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

March 1, 2023

Primary Completion (Actual)

January 31, 2024

Study Completion (Actual)

February 1, 2024

Study Registration Dates

First Submitted

September 21, 2023

First Submitted That Met QC Criteria

September 21, 2023

First Posted (Actual)

September 28, 2023

Study Record Updates

Last Update Posted (Actual)

February 21, 2024

Last Update Submitted That Met QC Criteria

February 19, 2024

Last Verified

February 1, 2024

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • ALA in Ischemic Cardiomyopathy

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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