Evaluation of Alpha-Lipoic Acid in Diabetic Cardiomyopathy

Study Overview
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Brief Summary
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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.

Official Title
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Evaluation of Alpha-Lipoic Acid in Diabetic Cardiomyopathy

Conditions
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Diabetic Cardiomyopathies

Intervention / Treatment
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* Dietary Supplement: Physiomance acide lipoïque gold
* Dietary Supplement: Placebo - Physiomance acide lipoïque gold


Participation Criteria
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Eligibility Criteria
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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. Non-inclusion 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;

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Other
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Alpha-Lipoic Acid group<br> | Dietary Supplement: Physiomance acide lipoïque gold<br>* 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<br>|
| Placebo Comparator: placebo group<br> | Dietary Supplement: Placebo - Physiomance acide lipoïque gold<br>* 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<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| change of LVEF between before and after 12 weeks of treatment | percentage of blood ejection before and after 12 weeks of treatment | 12 weeks |