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
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