Evaluation of Alpha-Lipoic Acid in Diabetic Cardiomyopathy
试验速览
- 阶段
- 不适用
- 状态
- 终止
- 入组人数
- 13
- 试验地点
- 1
- 主要终点
- change of LVEF between before and after 12 weeks of treatment
研究概览
简要总结
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Other
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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.
排除标准
- •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;
研究组 & 干预措施
Alpha-Lipoic Acid group
干预措施: Physiomance acide lipoïque gold (Dietary Supplement)
placebo group
干预措施: Placebo - Physiomance acide lipoïque gold (Dietary Supplement)
结局指标
主要结局
change of LVEF between before and after 12 weeks of treatment
时间窗: 12 weeks
percentage of blood ejection before and after 12 weeks of treatment
次要结局
未报告次要终点