Evaluation of Alpha-Lipoic Acid in Diabetic Cardiomyopathy

Overview

The heart has the ability to respond to different patho-physiological conditions by adapting its energy metabolism. In diabetic subjects, the myocardium uses only fatty acids as a substrate. This is the cause of diabetic cardiomyopathy (DCM). The activation of the transcription factor PPARβ/δ allows a good use of fatty acids. The staff have demonstrated that alpha lipoic acid (AαL), a molecule with antioxidant properties present in food supplements and in certain foods (broccoli, cabbage, offal…), induces the expression of PPARβ/δ in skeletal muscle and thus increases the activity of this transcription factor.

Study Type

  • Study Type: Interventional
  • Study Design
    • Allocation: Randomized
    • Intervention Model: Parallel Assignment
    • Primary Purpose: Other
    • Masking: None (Open Label)
  • Study Primary Completion Date: November 1, 2023

Interventions

  • Dietary Supplement: Physiomance acide lipoïque gold
    • 1 capsule of 300 mg in the morning outside a meal and 1 capsule of 300 mg in the evening outside a meal during 12 weeks
  • Dietary Supplement: Placebo – Physiomance acide lipoïque gold
    • 1 capsule of 300 mg in the morning outside a meal and 1 capsule of 300 mg in the evening outside a meal during 12 weeks

Arms, Groups and Cohorts

  • Active Comparator: Alpha-Lipoic Acid group
  • Placebo Comparator: placebo group

Clinical Trial Outcome Measures

Primary Measures

  • change of LVEF between before and after 12 weeks of treatment
    • Time Frame: 12 weeks
    • percentage of blood ejection before and after 12 weeks of treatment

Participating in This Clinical Trial

Inclusion Criteria

  • Male or female adult age ≥ 18 years – patient with diagnosed type 2 diabetes (history of pathological hyperglycemia according to WHO and HbA1c standards >7% or ongoing treatment with oral antidiabetic agents). – Patients with stable cardiomyopathy (no hospitalization in cardiology in the month before inclusion) with a left ventricular ejection fraction (LVEF) <50%. – patient who has signed an informed consent form – For women of childbearing age: effective contraception followed for at least 3 months before the start of the study and agreeing to keep it for the duration of the study. – affiliation to a social security scheme. Exclusion Criteria:

subjects:

  • With a coronary event in the year before inclusion. – With symptoms of cardiac ischemia at inclusion. – Pregnant or breastfeeding woman – Severe renal insufficiency – Using antioxidant molecules in the 6 months prior to inclusion. – Using drugs that can activate PPARs (Fibrates, Telmisartan, Enalaprilat). – Using anti-inflammatory drugs. – Suffering from acute infectious diseases and inflammatory diseases. – Hypersensitivity or a history of hypersensitivity reaction to gadoteric acid, meglumine or any drug containing gadolinium. Noninclusion criteria related to MRI: – with an implanted vascular stent less than 6 weeks before the examination; – carrier of an implanted biomedical device deemed "not safe" or "unsafe" in the list: http://www.mrisafety.com/TheList_search.asp; – Beneficiary of an acquisition procedure that does not respect the conditions required by "conditional" use in a subject carrying an implanted biomedical material considered "conditional" in the list: http://www.mrisafety.com/TheList_search.asp; – carrier of a ferromagnetic intraocular or intracranial foreign body close to the nerve structures; – carrying biomedical equipment such as a cardiac, neural or sensory pacemaker (cochlear implant) or a ventricular bypass valve without medical and paramedical supervision trained to perform MRI in these subjects;

Gender Eligibility: All

Minimum Age: 18 Years

Maximum Age: N/A

Are Healthy Volunteers Accepted: No

Investigator Details

  • Lead Sponsor
    • Centre Hospitalier Universitaire de Nice
  • Provider of Information About this Clinical Study
    • Sponsor

Clinical trials entries are delivered from the US National Institutes of Health and are not reviewed separately by this site. Please see the identifier information above for retrieving further details from the government database.

At TrialBulletin.com, we keep tabs on over 200,000 clinical trials in the US and abroad, using medical data supplied directly by the US National Institutes of Health. Please see the About and Contact page for details.