Evaluation of Alpha-Lipoic Acid in Diabetic Cardiomyopathy

Not Applicable

Terminated

• Conditions: Diabetic Cardiomyopathies
• Interventions: Dietary Supplement: Placebo - Physiomance acide lipoïque gold; Dietary Supplement: Physiomance acide lipoïque gold

• Registration Number: NCT04141475
• Lead Sponsor: Centre Hospitalier Universitaire de Nice

Brief 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.

Detailed Description

Not available

Basic Information
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Recruitment & Eligibility
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Study & Design
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Trial Locations

Study Timeline

• Study First Submitted: 2019-10-25
• Study First Submitted QC: 2019-10-25
• Study First Posted: 2019-10-28
• Study Start: 2020-11-24
• Primary Completion: 2023-11-01
• Study Completion: 2023-12-01
• Status Verified: 2024-02
• Last Update Submitted: 2024-02-02
• Last Update Posted: 2024-02-05

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 13

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.

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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;

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
placebo group	Placebo - Physiomance acide lipoïque gold	-
Alpha-Lipoic Acid group	Physiomance acide lipoïque gold	-

Primary Outcome Measures

Name	Time	Method
change of LVEF between before and after 12 weeks of treatment	12 weeks	percentage of blood ejection before and after 12 weeks of treatment

Trial Locations

Locations (1)

Nice Hospital; 🇫🇷 Nice, France