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Alpha-lipoic Acid in Diabetic Patients With Ischemic Cardiomyopathy

Sponsor
Damanhour University (Other)
Overall Status
Recruiting
CT.gov ID
NCT06056687
Collaborator
(none)
60
Enrollment
1
Location
2
Arms
10.1
Anticipated Duration (Months)
6
Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase
  • Drug: Alpha Lipoic Acid 600 MG Oral Tablet
  • Other: Placebo Tablet
 N/A

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 Design

Study Type:
Interventional
Anticipated Enrollment :
60 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
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.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 (Participant, Investigator)
Masking Description:
Double Blind
Primary Purpose:
Treatment
Official Title:
Effect of Alpha-lipoic Acid on Inflammatory and Cardiac Fibrosis Markers in Diabetic Patients With Ischemic Cardiomyopathy
Actual Study Start Date :
Mar 1, 2023
Anticipated Primary Completion Date :
Dec 31, 2023
Anticipated Study Completion Date :
Jan 1, 2024

Arms and Interventions

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

    		•

    Outcome Measures

    Primary Outcome Measures

    1. C-reactive protein (CRP) [3 month]

      Serum Biomarker (mg/ml)

    2. Tumor necrosis factor alpha (TNFα)] [3 Months]

      Serum Biomarker (pg/ml)

    3. Transforming growth factor beta (TGFβ) [3 Months]

      fibrosis markers (ng/ml)

    4. Matrix metalloproteinase 2 (MMP-2) [3 Months]

      fibrosis markers (ng/ml)

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    20 Years to 75 Years
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    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.

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Damanhour Teaching Hospital, General Organization for Teaching Hospitals and Institutes. Damanhūr Elbehairah Egypt 31527

    Sponsors and Collaborators

    • Damanhour University

    Investigators

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

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Rehab Werida, Associate Professor, Damanhour University
    ClinicalTrials.gov Identifier:
    NCT06056687
    Other Study ID Numbers:
    • ALA in Ischemic Cardiomyopathy
    First Posted:
    Sep 28, 2023
    Last Update Posted:
    Sep 28, 2023
    Last Verified:
    Sep 1, 2023
    Studies a U.S. FDA-regulated Drug Product:
    No
    Studies a U.S. FDA-regulated Device Product:
    No
    Additional relevant MeSH terms:
    Cardiomyopathies
    Ischemia
    Thioctic Acid

    Study Results

    No Results Posted as of Sep 28, 2023