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Evaluation of Alpha-Lipoic Acid in Diabetic Cardiomyopathy

Перакладаць артыкулы могуць толькі зарэгістраваныя карыстальнікі
Увайсці / Зарэгістравацца
Спасылка захоўваецца ў буферы абмену
СтатусЯшчэ не завербаваны
Спонсары
Centre Hospitalier Universitaire de Nice

Ключавыя словы

Рэферат

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.

Даты

Апошняя праверка: 09/30/2019
Упершыню прадстаўлена: 10/24/2019
Меркаваная колькасць заявак прадстаўлена: 10/24/2019
Першае паведамленне: 10/27/2019
Апошняе абнаўленне адпраўлена: 10/24/2019
Апошняе абнаўленне апублікавана: 10/27/2019
Фактычная дата пачатку даследавання: 12/31/2019
Разліковая дата першаснага завяршэння: 12/31/2021
Разліковая дата завяршэння даследавання: 08/31/2022

Стан альбо хвароба

Diabetic Cardiomyopathies

Ўмяшанне / лячэнне

Dietary Supplement: Alpha-Lipoic Acid group

Dietary Supplement: placebo group

Фаза

-

Групы ўзбраенняў

РукаЎмяшанне / лячэнне
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

Крытэрыі прыдатнасці

Узрост, які мае права на вучобу 18 Years Каб 18 Years
Пол, прыдатны для навучанняAll
Прымае здаровых валанцёраўТак
Крытэрыі

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;

Вынік

Першасныя вынікі

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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