Clinical trial NCT04141475: Evaluation of Alpha-Lipoic Acid in Diabetic Cardiomyopathy
Official title: Evaluation of Alpha-Lipoic Acid in Diabetic Cardiomyopathy
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: NA
Conditions: Diabetic Cardiomyopathies
Lead sponsor: Centre Hospitalier Universitaire de Nice
Sponsor class: OTHER
First posted: 2019-10-28
Enrollment: 13
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: OTHER

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.


Eligibility criteria: 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;

Primary outcomes:
measure: change of LVEF between before and after 12 weeks of treatment
timeFrame: 12 weeks
Secondary outcomes:
Other outcomes:
Locations:
city: Nice
country: France
facility: Nice Hospital
Study officials:
References: