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
-
-
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
|
Alpha Lipoic Acid 600 MG Oral Tablet once daily
Other Names:
|
|
Placebo Comparator: Placebo Group
the second group on placebo once daily
|
Placebo Tablet once daily
Other Names:
|
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
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.