Ischemic CardiomyopathyNCT06056687
Alpha-lipoic Acid in Diabetic Patients With Ischemic Cardiomyopathy
A study testing Alpha Lipoic Acid 600 MG Oral Tablet in people with Ischemic Cardiomyopathy and Diabetes Mellitus, run by Damanhour University at 1 site in Egypt.
Trial 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. Read more about this study
- Who is it for?
- Ages 20 to 75 years
- Conditions the study is for
- Ischemic Cardiomyopathy, Diabetes Mellitus
- What is being tested?
- Alpha Lipoic Acid 600 MG Oral Tablet
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 60 participants
- Where
- 1 siteEgypt
- Study dates
- 1 Mar 2023to 1 Feb 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 20 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Type 2 diabetes with a history of CAD.
- LV ejection fraction (LVEF) ≤40%.
- Ischemic heart failure patients with NYHA grade II-IV.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
Egypt1 site
Damanhour Teaching Hospital, General Organization for Teaching Hospitals and Institutes.
Damanhūr, Elbehairah, 31527
About this study
Official title: 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.
Read the 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.
- Conditions
- Ischemic Cardiomyopathy, Diabetes Mellitus
- Being tested
- Alpha Lipoic Acid 600 MG Oral Tablet, Placebo Tablet
- Medical subject headings
- Diabetes Mellitus
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Alpha Lipoic Acid 600 MG Oral TabletDrug
Also called Thiotacid 600 mg
Alpha Lipoic Acid 600 MG Oral Tablet once daily
Placebo TabletOther
Also called Placebo
Placebo Tablet once daily
| Study group | Role | What they receive |
|---|---|---|
| Alpha Lipoic Acid Group | Experimental | ALA 600 mg once daily Receives: Drug: Alpha Lipoic Acid 600 MG Oral Tablet |
| Placebo Group | Placebo comparator | the second group on placebo once daily Receives: Other: Placebo Tablet |
What is being measured
The primary outcome is the main question the study is designed to answer.
C-reactive protein (CRP)
Serum Biomarker (mg/ml)
Measured: 3 month
Tumor necrosis factor alpha (TNFα)]
Serum Biomarker (pg/ml)
Measured: 3 Months
Transforming growth factor beta (TGFβ)
fibrosis markers (ng/ml)
Measured: 3 Months
Matrix metalloproteinase 2 (MMP-2)
fibrosis markers (ng/ml)
Measured: 3 Months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Sep 2023
- Study start1 Mar 2023
- Primary completion31 Jan 2024
- Study completion1 Feb 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Ischemic CardiomyopathyStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- 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.
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 60 participants (actual)
Sponsor and investigators
- Lead sponsor
- Damanhour University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Rehab Werida, Damanhour University
- Investigators
- Rehab H Werida, Ass Prof., Study chair, Damanhour UniversityNoha El bassiouny, Lecturer, Study director, Damanhour University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06056687
- Sponsor's protocol ID
- ALA in Ischemic Cardiomyopathy
- Status last verified
- Feb 2024
- First submitted
- 21 Sep 2023
- Last updated
- 21 Feb 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 21 Feb 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Alpha-lipoic Acid on Inflammatory and Cardiac Fibrosis Markers in Diabetic Patients With Ischemic Cardiomyopathy
- ClinicalTrials.gov ID
- NCT06056687
- Acronym / sponsor ID
- ALA in Ischemic Cardiomyopathy
- Conditions
- Ischemic Cardiomyopathy, Diabetes Mellitus
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- Damanhour UniversityUniversity, hospital or other
- Study start
- 1 Mar 2023 (actual)
- Primary completion
- 31 Jan 2024 (actual)
- Study completion
- 1 Feb 2024 (actual)
- First posted
- 28 Sep 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
- 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.
| Arm | Type | Receives |
|---|---|---|
| Alpha Lipoic Acid Group | Experimental | Drug: Alpha Lipoic Acid 600 MG Oral TabletALA 600 mg once daily |
| Placebo Group | Placebo comparator | Other: Placebo Tabletthe second group on placebo once daily |
Who may qualify
- Ages
- 20 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Type 2 diabetes with a history of CAD.
- LV ejection fraction (LVEF) ≤40%.
- Ischemic heart failure patients with NYHA grade II-IV.
Key exclusion criteria (6 listed)
- Type 1 diabetes.
- Severe CKD with GFR ≤ 15 ml/min/1.73m^2.
- Severe liver disease.
- Thyroid disorders.
- Acute febrile illness.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Alpha Lipoic Acid 600 MG Oral TabletAlso: Thiotacid 600 mgAlpha Lipoic Acid 600 MG Oral Tablet once daily | Drug | Alpha Lipoic Acid Group |
| Placebo TabletAlso: PlaceboPlacebo Tablet once daily | Other | Placebo Group |
Primary outcome
C-reactive protein (CRP)
Time frame: 3 month
Serum Biomarker (mg/ml)
Tumor necrosis factor alpha (TNFα)]
Time frame: 3 Months
Serum Biomarker (pg/ml)
Transforming growth factor beta (TGFβ)
Time frame: 3 Months
fibrosis markers (ng/ml)
Matrix metalloproteinase 2 (MMP-2)
Time frame: 3 Months
fibrosis markers (ng/ml)
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Feb 2024.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Rehab H Werida, Ass Prof. study chair
Damanhour University
Noha El bassiouny, Lecturer study director
Damanhour University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Alpha Lipoic Acid 600 MG Oral Tablet in people with Ischemic Cardiomyopathy and Diabetes Mellitus, run by Damanhour University at 1 site in Egypt.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 21 Feb 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Egypt. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
C-reactive protein (CRP) (time frame: 3 month). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 21 Feb 2024.