Evaluation of Alpha-Lipoic Acid in Diabetic Cardiomyopathy (NCT04141475) | Clinical Trial Compass
TerminatedNot Applicable
Evaluation of Alpha-Lipoic Acid in Diabetic Cardiomyopathy
Stopped: no patient recruitment
France13 participantsStarted 2020-11-24
Plain-language summary
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.
Who can participate
Age range
18 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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 …
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
change of LVEF between before and after 12 weeks of treatment