Evaluation of Alpha-Lipoic Acid in Diabetic Cardiomyopathy

NCT ID: NCT04141475

Last Updated: 2024-02-05

Basic Information

• Recruitment Status: TERMINATED
• Clinical Phase: NA
• Total Enrollment: 13 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2020-11-24
• Study Completion Date: 2023-12-01

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.

Conditions

Diabetic Cardiomyopathies

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: OTHER
• Blinding Strategy: NONE

Study Groups

Alpha-Lipoic Acid group

Group Type: ACTIVE_COMPARATOR

Physiomance acide lipoïque gold

Intervention Type: DIETARY_SUPPLEMENT

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 group

Group Type: PLACEBO_COMPARATOR

Placebo - Physiomance acide lipoïque gold

Intervention Type: DIETARY_SUPPLEMENT

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

Interventions

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

Intervention Type: DIETARY_SUPPLEMENT

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

Intervention Type: DIETARY_SUPPLEMENT

Eligibility Criteria

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.

• 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;

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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Centre Hospitalier Universitaire de Nice

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

Nice Hospital

Nice, , France

Countries

France

Other Identifiers

19-PP-07

Identifier Type: -

Identifier Source: org_study_id