Diabetic Cardiomyopathies
Conditions
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.
Interventions
DIETARY_SUPPLEMENTPhysiomance 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_SUPPLEMENTPlacebo - 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
Sponsors
Centre Hospitalier Universitaire de Nice
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
OTHER
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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;
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| change of LVEF between before and after 12 weeks of treatment | 12 weeks | percentage of blood ejection before and after 12 weeks of treatment |
Countries
France
Outcome results
None listed