Evaluation of Alpha-Lipoic Acid in Diabetic Cardiomyopathy
キーワード
概要
日付
| 最終確認済み: | 09/30/2019 |
| 最初に提出された: | 10/24/2019 |
| 提出された推定登録数: | 10/24/2019 |
| 最初の投稿: | 10/27/2019 |
| 最終更新が送信されました: | 10/24/2019 |
| 最終更新日: | 10/27/2019 |
| 実際の研究開始日: | 12/31/2019 |
| 一次完了予定日: | 12/31/2021 |
| 研究完了予定日: | 08/31/2022 |
状態または病気
介入/治療
Dietary Supplement: Alpha-Lipoic Acid group
Dietary Supplement: placebo group
段階
アームグループ
| 腕 | 介入/治療 |
|---|---|
| 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 |
適格基準
| 研究の対象となる年齢 | 18 Years に 18 Years |
| 研究に適格な性別 | All |
| 健康なボランティアを受け入れる | はい |
| 基準 | 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; |
結果
主な結果の測定
1. change of LVEF between before and after 12 weeks of treatment [12 weeks]
