Evaluation of Alpha-Lipoic Acid in Diabetic Cardiomyopathy (CARDIALA)

Centre Hospitalier Universitaire de Nice

Status

Terminated

Conditions

Diabetic Cardiomyopathies

Treatments

Dietary Supplement: Placebo - Physiomance acide lipoïque gold

Dietary Supplement: Physiomance acide lipoïque gold

Study type

Interventional

Funder types

Other

Identifiers

NCT04141475

19-PP-07

Details and patient eligibility

About

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.

Enrollment

13 patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

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;