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Evaluation of Alpha-Lipoic Acid in Diabetic Cardiomyopathy (CARDIALA)

Primary Purpose

Diabetic Cardiomyopathies

Status
Unknown status
Phase
Not Applicable
Locations
France
Study Type
Interventional
Intervention
Physiomance acide lipoïque gold
Placebo - Physiomance acide lipoïque gold
Sponsored by
Centre Hospitalier Universitaire de Nice
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional other trial for Diabetic Cardiomyopathies

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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;

Sites / Locations

  • Nice HospitalRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Placebo Comparator

Arm Label

Alpha-Lipoic Acid group

placebo group

Arm Description

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

Full Information

First Posted
October 25, 2019
Last Updated
December 7, 2020
Sponsor
Centre Hospitalier Universitaire de Nice
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1. Study Identification

Unique Protocol Identification Number
NCT04141475
Brief Title
Evaluation of Alpha-Lipoic Acid in Diabetic Cardiomyopathy
Acronym
CARDIALA
Official Title
Evaluation of Alpha-Lipoic Acid in Diabetic Cardiomyopathy
Study Type
Interventional

2. Study Status

Record Verification Date
December 2020
Overall Recruitment Status
Unknown status
Study Start Date
November 24, 2020 (Actual)
Primary Completion Date
November 1, 2022 (Anticipated)
Study Completion Date
December 1, 2022 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Centre Hospitalier Universitaire de Nice

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Diabetic Cardiomyopathies

7. Study Design

Primary Purpose
Other
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
100 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Alpha-Lipoic Acid group
Arm Type
Active Comparator
Arm Title
placebo group
Arm Type
Placebo Comparator
Intervention Type
Dietary Supplement
Intervention Name(s)
Physiomance acide lipoïque gold
Intervention Description
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
Intervention Name(s)
Placebo - Physiomance acide lipoïque gold
Intervention Description
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
Primary Outcome Measure Information:
Title
change of LVEF between before and after 12 weeks of treatment
Description
percentage of blood ejection before and after 12 weeks of treatment
Time Frame
12 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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. 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;
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Emile FERRARI, PUPH
Phone
33 4 92 03 77 35
Email
ferrari.e@chu-nice.fr
Facility Information:
Facility Name
Nice Hospital
City
Nice
ZIP/Postal Code
06000
Country
France
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Emile FERRARI, PUPH
Phone
33- 04 92 03 77 35
Email
ferrari.e@chu-nice.fr
First Name & Middle Initial & Last Name & Degree
emile FERRARI, PUPH
First Name & Middle Initial & Last Name & Degree
charlotte DAVID, PH

12. IPD Sharing Statement

Plan to Share IPD
No

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Evaluation of Alpha-Lipoic Acid in Diabetic Cardiomyopathy

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