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Evaluation of Alpha-Lipoic Acid in Diabetic Cardiomyopathy

Само регистрирани потребители могат да превеждат статии
Вход / Регистрация
Линкът е запазен в клипборда
СъстояниеВсе още не набира
Спонсори
Centre Hospitalier Universitaire de Nice

Ключови думи

Резюме

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.

Дати

Последна проверка: 09/30/2019
Първо изпратено: 10/24/2019
Очаквано записване подадено: 10/24/2019
Първо публикувано: 10/27/2019
Изпратена последна актуализация: 10/24/2019
Последна актуализация публикувана: 10/27/2019
Действителна начална дата на проучването: 12/31/2019
Приблизителна дата на първично завършване: 12/31/2021
Очаквана дата на завършване на проучването: 08/31/2022

Състояние или заболяване

Diabetic Cardiomyopathies

Интервенция / лечение

Dietary Supplement: Alpha-Lipoic Acid group

Dietary Supplement: placebo group

Фаза

-

Групи за ръце

ArmИнтервенция / лечение
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

Критерии за допустимост

Възрасти, отговарящи на условията за проучване 18 Years Да се 18 Years
Полове, допустими за проучванеAll
Приема здрави доброволциДа
Критерии

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;

Резултат

Първични изходни мерки

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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