Alpha-lipoic Acid in Diabetic Patients With Ischemic Cardiomyopathy

NCT06056687 | Completed

• 1 other identifier: ALA in Ischemic Cardiomyopathy
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

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.

Conditions

Ischemic Cardiomyopathy; Diabetes Mellitus

Outcome Measures

Primary Outcomes (4)

• 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

Study Arms (2)

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

Alpha Lipoic Acid 600 MG Oral Tablet DRUG

Alpha Lipoic Acid 600 MG Oral Tablet once daily

Also known as: Thiotacid 600 mg

Alpha Lipoic Acid Group

Placebo Tablet OTHER

Placebo Tablet once daily

Also known as: Placebo

Placebo Group

Eligibility Criteria

• Age: 20 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Type 2 diabetes with a history of CAD.
• LV ejection fraction (LVEF) ≤40%.
• Ischemic heart failure patients with NYHA grade II-IV.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Damanhour University: lead

Study Sites (1)

Damanhour Teaching Hospital, General Organization for Teaching Hospitals and Institutes.

Damanhūr, Elbehairah, 31527, Egypt

Location

MeSH Terms

Conditions

Diabetes Mellitus

Interventions

Thioctic Acid; Tablets

Condition Hierarchy (Ancestors)

Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases

Intervention Hierarchy (Ancestors)

Carboxylic Acids; Organic Chemicals; Thiophenes; Sulfur Compounds; Coenzymes; Enzymes and Coenzymes; Fatty Acids; Lipids; Dosage Forms; Pharmaceutical Preparations

Study Officials

• Rehab H Werida, Ass Prof.

  Damanhour University

  STUDY CHAIR

• Noha El bassiouny, Lecturer

  Damanhour University

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Masking Details: Double Blind
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor

Model Details: 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.

Study Record Dates

• First Submitted: September 21, 2023
• First Posted: September 28, 2023
• Study Start: March 1, 2023
• Primary Completion: January 31, 2024
• Study Completion: February 1, 2024
• Last Updated: February 21, 2024

Record last verified: 2024-02

Locations

EG (1)