Evaluation of Alpha-Lipoic Acid in Diabetic Cardiomyopathy
Ключови думи
Резюме
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
Интервенция / лечение
Dietary Supplement: Alpha-Lipoic Acid group
Dietary Supplement: placebo group
Фаза
Групи за ръце
Arm | Интервенция / 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 проучване | All |
Приема здрави доброволци | Да |
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]