Diabetic CardiomyopathiesCARDIALANCT04141475
Evaluation of Alpha-Lipoic Acid in Diabetic Cardiomyopathy
A study testing Physiomance acide lipoïque gold in people with Diabetic Cardiomyopathies, run by Centre Hospitalier Universitaire de Nice at 1 site in France.
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). Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Diabetic Cardiomyopathies
- What is being tested?
- Physiomance acide lipoïque gold
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 13 participants
- Where
- 1 siteFrance
- Study dates
- 24 Nov 2020to 1 Dec 2023
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
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- 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;
Trial locations and contacts
1 site in 1 country.
About this study
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
- Being tested
- Physiomance acide lipoïque gold, Placebo - Physiomance acide lipoïque gold
- Medical subject headings
- Diabetic Cardiomyopathies
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Physiomance acide lipoïque goldDietary 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 - Physiomance acide lipoïque goldDietary 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
| Study group | Role | What they receive |
|---|---|---|
| Alpha-Lipoic Acid group | Active comparator | Not described Receives: Dietary Supplement: Physiomance acide lipoïque gold |
| placebo group | Placebo comparator | Not described Receives: Dietary Supplement: Placebo - Physiomance acide lipoïque gold |
What is being measured
The primary outcome is the main question the study is designed to answer.
change of LVEF between before and after 12 weeks of treatment
percentage of blood ejection before and after 12 weeks of treatment
Measured: 12 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Oct 2019
- Study start24 Nov 2020
- Primary completion1 Nov 2023
- Study completion1 Dec 2023
Why it stopped: no patient recruitment
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Diabetic CardiomyopathiesStudies of the same condition, open and under way.
- More trials run by Centre Hospitalier Universitaire de NiceThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 13 participants (actual)
Sponsor and investigators
- Lead sponsor
- Centre Hospitalier Universitaire de Nice
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04141475
- Sponsor's protocol ID
- 19-PP-07
- Acronym
- CARDIALA
- Status last verified
- Feb 2024
- First submitted
- 25 Oct 2019
- Last updated
- 5 Feb 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 5 Feb 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of Alpha-Lipoic Acid in Diabetic Cardiomyopathy
- ClinicalTrials.gov ID
- NCT04141475
- Acronym / sponsor ID
- CARDIALA / 19-PP-07
- Conditions
- Diabetic Cardiomyopathies
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: no patient recruitment
- Enrolment
- 13 participants (actual)
- Lead sponsor
- Centre Hospitalier Universitaire de NiceUniversity, hospital or other
- Study start
- 24 Nov 2020 (actual)
- Primary completion
- 1 Nov 2023 (actual)
- Study completion
- 1 Dec 2023 (actual)
- First posted
- 28 Oct 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Alpha-Lipoic Acid group | Active comparator | Dietary Supplement: Physiomance acide lipoïque gold |
| placebo group | Placebo comparator | Dietary Supplement: Placebo - Physiomance acide lipoïque gold |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 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.
Key exclusion criteria (16 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Physiomance acide lipoïque gold1 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 | Dietary supplement | Alpha-Lipoic Acid group |
| Placebo - Physiomance acide lipoïque gold1 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 | Dietary supplement | placebo group |
Primary outcome
change of LVEF between before and after 12 weeks of treatment
Time frame: 12 weeks
percentage of blood ejection before and after 12 weeks of treatment
Results and safety
The study was stopped early (reason given: no patient recruitment). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Feb 2024.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Physiomance acide lipoïque gold in people with Diabetic Cardiomyopathies, run by Centre Hospitalier Universitaire de Nice at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 16 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 5 Feb 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was stopped early (reason given: no patient recruitment). Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
change of LVEF between before and after 12 weeks of treatment (time frame: 12 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 Feb 2024.