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Evaluation of Alpha-Lipoic Acid in Diabetic Cardiomyopathy

Rakstu tulkošanu var veikt tikai reģistrēti lietotāji
Ielogoties Reģistrēties
Saite tiek saglabāta starpliktuvē
StatussVēl nepieņem darbā
Sponsori
Centre Hospitalier Universitaire de Nice

Atslēgvārdi

Abstrakts

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.

Datumi

Pēdējoreiz pārbaudīts: 09/30/2019
Pirmais iesniegtais: 10/24/2019
Paredzētā reģistrācija iesniegta: 10/24/2019
Pirmais izlikts: 10/27/2019
Pēdējais atjauninājums iesniegts: 10/24/2019
Pēdējā atjaunināšana ievietota: 10/27/2019
Faktiskais studiju sākuma datums: 12/31/2019
Paredzamais primārās pabeigšanas datums: 12/31/2021
Paredzamais pētījuma pabeigšanas datums: 08/31/2022

Stāvoklis vai slimība

Diabetic Cardiomyopathies

Iejaukšanās / ārstēšana

Dietary Supplement: Alpha-Lipoic Acid group

Dietary Supplement: placebo group

Fāze

-

Roku grupas

RokaIejaukšanās / ārstēšana
Active Comparator: Alpha-Lipoic Acid group
Dietary Supplement: Alpha-Lipoic Acid group
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 group
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

Atbilstības kritēriji

Vecums, kas piemērots studijām 18 Years Uz 18 Years
Dzimumi, kas ir piemēroti studijāmAll
Pieņem veselīgus brīvprātīgos
Kritēriji

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;

Rezultāts

Primārie rezultāti

1. change of LVEF between before and after 12 weeks of treatment [12 weeks]

percentage of blood ejection before and after 12 weeks of treatment

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