CARDIALA: Evaluation of Alpha-Lipoic Acid in Diabetic Cardiomyopathy
Study Details
Study Description
Brief Summary
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.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
N/A |
Study Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Active Comparator: Alpha-Lipoic Acid group
|
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
|
| Placebo Comparator: placebo group
|
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
|
Outcome Measures
Primary Outcome Measures
- change of LVEF between before and after 12 weeks of treatment [12 weeks]
percentage of blood ejection before and after 12 weeks of treatment
Eligibility Criteria
Criteria
Inclusion Criteria:
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Male or female adult age ≥ 18 years
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patient with diagnosed type 2 diabetes (history of pathological hyperglycemia according to WHO and HbA1c standards >7% or ongoing treatment with oral antidiabetic agents).
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Patients with stable cardiomyopathy (no hospitalization in cardiology in the month before inclusion) with a left ventricular ejection fraction (LVEF) <50%.
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patient who has signed an informed consent form
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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.
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affiliation to a social security scheme.
Exclusion Criteria:
subjects:
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With a coronary event in the year before inclusion.
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With symptoms of cardiac ischemia at inclusion.
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Pregnant or breastfeeding woman
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Severe renal insufficiency
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Using antioxidant molecules in the 6 months prior to inclusion.
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Using drugs that can activate PPARs (Fibrates, Telmisartan, Enalaprilat).
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Using anti-inflammatory drugs.
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Suffering from acute infectious diseases and inflammatory diseases.
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Hypersensitivity or a history of hypersensitivity reaction to gadoteric acid, meglumine or any drug containing gadolinium.
Non-inclusion criteria related to MRI:
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with an implanted vascular stent less than 6 weeks before the examination;
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carrier of an implanted biomedical device deemed "not safe" or "unsafe" in the list: http://www.mrisafety.com/TheList_search.asp;
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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;
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carrier of a ferromagnetic intraocular or intracranial foreign body close to the nerve structures;
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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;
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Nice Hospital | Nice | France | 06000 |
Sponsors and Collaborators
- Centre Hospitalier Universitaire de Nice
Investigators
None specified.Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- 19-PP-07