Evaluation of Alpha-Lipoic Acid in Diabetic Cardiomyopathy
Märksõnad
Abstraktne
Kuupäevad
Viimati kinnitatud: | 09/30/2019 |
Esmalt esitatud: | 10/24/2019 |
Hinnanguline registreerumine on esitatud: | 10/24/2019 |
Esmalt postitatud: | 10/27/2019 |
Viimane värskendus on esitatud: | 10/24/2019 |
Viimati värskendus postitatud: | 10/27/2019 |
Õppe tegelik alguskuupäev: | 12/31/2019 |
Eeldatav esmane lõpetamise kuupäev: | 12/31/2021 |
Eeldatav uuringu lõpetamise kuupäev: | 08/31/2022 |
Seisund või haigus
Sekkumine / ravi
Dietary Supplement: Alpha-Lipoic Acid group
Dietary Supplement: placebo group
Faas
Käerühmad
Arm | Sekkumine / ravi |
---|---|
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 |
Abikõlblikkuse kriteeriumid
Õppimiseks sobivad vanused | 18 Years To 18 Years |
Uuringuks kõlblikud sood | All |
Võtab vastu tervislikke vabatahtlikke | Jah |
Kriteeriumid | 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; |
Tulemus
Esmased tulemusnäitajad
1. change of LVEF between before and after 12 weeks of treatment [12 weeks]