Evaluation of Alpha-Lipoic Acid in Diabetic Cardiomyopathy

Diabetic Cardiomyopathies Clinical Trial

— CARDIALA  

Official title:

Evaluation of Alpha-Lipoic Acid in Diabetic Cardiomyopathy

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT04141475
• Other study ID #: 19-PP-07
• Status: Terminated
• Phase: N/A
• Start date: November 24, 2020
• Est. completion date: December 1, 2023

Study information

• Verified date: February 2024
• Source: Centre Hospitalier Universitaire de Nice
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 13
• Est. completion date: December 1, 2023
• Est. primary completion date: November 1, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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;

Related Conditions & MeSH terms

• Cardiomyopathies
• Diabetic Cardiomyopathies

Intervention

Dietary Supplement:
• Physiomance acide lipoïque gold
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 - Physiomance acide lipoïque gold
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

Locations

Country	Name	City	State
France	Nice Hospital	Nice

Sponsors (1)

Lead Sponsor	Collaborator
Centre Hospitalier Universitaire de Nice

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	change of LVEF between before and after 12 weeks of treatment	percentage of blood ejection before and after 12 weeks of treatment	12 weeks