Diabetic Cardiomyopathies Clinical Trial
— CARDIALAOfficial title:
Evaluation of Alpha-Lipoic Acid in Diabetic Cardiomyopathy
Verified date | February 2024 |
Source | Centre Hospitalier Universitaire de Nice |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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.
Status | Terminated |
Enrollment | 13 |
Est. completion date | December 1, 2023 |
Est. primary completion date | November 1, 2023 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years and older |
Eligibility | 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; |
Country | Name | City | State |
---|---|---|---|
France | Nice Hospital | Nice |
Lead Sponsor | Collaborator |
---|---|
Centre Hospitalier Universitaire de Nice |
France,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | change of LVEF between before and after 12 weeks of treatment | percentage of blood ejection before and after 12 weeks of treatment | 12 weeks |
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