Alpha-lipoic Acid in Diabetic Patients With Ischemic Card... | NCT06056687

Studies
Alpha-lipoic Acid in Diabetic Patients With Ischemic Cardiomyopathy

NCT06056687

Sponsor

Damanhour University

Status

Completed

Last Update Posted

Feb 21, 2024Actual

Enrollment

60Actual

Phase

Not Applicable

Conditions

Ischemic Cardiomyopathy
Diabetes Mellitus

Interventions

Alpha Lipoic Acid 600 MG Oral Tablet
Placebo Tablet

Countries

Egypt

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Feb 2024

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Mar 1, 2023Actual

Primary Completion Date

Jan 31, 2024Actual

Completion Date

Feb 1, 2024Actual

First Submitted Date

Sep 21, 2023

First Submission Date that Met QC Criteria

Sep 21, 2023

First Posted Date

Sep 28, 2023Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Feb 19, 2024

Last Update Posted Date

Feb 21, 2024Actual

Sponsor/Collaborators Module

Responsible Party, by Official Title

Rehab Werida, Associate Professor, Damanhour UniversityPrincipal Investigator

Lead Sponsor

Damanhour UniversityOTHER

Collaborators

Not provided

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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.

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

60Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Alpha Lipoic Acid Group	Experimental	ALA 600 mg once daily	Drug: Alpha Lipoic Acid 600 MG Oral Tablet
Placebo Group	Placebo Comparator	the second group on placebo once daily	Other: Placebo Tablet

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Alpha Lipoic Acid 600 MG Oral Tablet	Drug	Alpha Lipoic Acid 600 MG Oral Tablet once daily	Alpha Lipoic Acid Group

Outcomes Module

Primary Outcomes

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

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

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.

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

20 Years

Maximum Age

75 Years

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Rehab H Werida, Ass Prof.	Damanhour University	Study Chair
Noha El bassiouny, Lecturer	Damanhour University	Study Director

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Damanhour Teaching Hospital, General Organization for Teaching Hospitals and Institutes.		Damanhūr	Elbehairah	31527	Egypt

Condition Browse Module

MeSH Terms

ID	Term
D003920	Diabetes Mellitus

Ancestor Terms

ID	Term
D044882	Glucose Metabolism Disorders
D008659	Metabolic Diseases
D009750	Nutritional and Metabolic Diseases
D004700	Endocrine System Diseases

Browse Leaves

Not provided

Browse Branches

Not provided

Intervention Browse Module

MeSH Terms

ID	Term
D008063	Thioctic Acid
D013607	Tablets

Ancestor Terms

ID	Term
D002264	Carboxylic Acids
D009930	Organic Chemicals
D013876	Thiophenes
D013457	Sulfur Compounds

Browse Leaves

Not provided

Browse Branches

Not provided

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.