NCT04141475

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.

Trial Health

57
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
13

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Nov 2020

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
terminated

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

October 25, 2019

Completed
3 days until next milestone

First Posted

Study publicly available on registry

October 28, 2019

Completed
1.1 years until next milestone

Study Start

First participant enrolled

November 24, 2020

Completed
2.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 1, 2023

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2023

Completed
Last Updated

February 5, 2024

Status Verified

February 1, 2024

Enrollment Period

2.9 years

First QC Date

October 25, 2019

Last Update Submit

February 2, 2024

Conditions

Diabetic Cardiomyopathies

Outcome Measures

Primary Outcomes (1)

  • change of LVEF between before and after 12 weeks of treatment

    percentage of blood ejection before and after 12 weeks of treatment

    12 weeks

Study Arms (2)

Alpha-Lipoic Acid group

ACTIVE COMPARATOR
Dietary Supplement: Physiomance acide lipoïque gold

placebo group

PLACEBO COMPARATOR
Dietary Supplement: Placebo - Physiomance acide lipoïque gold

Interventions

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

Alpha-Lipoic Acid group
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

placebo group

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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).
  • 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.

You may not qualify if:

  • subjects:
  • Pregnant or breastfeeding woman
  • Severe renal insufficiency
  • 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.
  • 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;

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Nice Hospital

Nice, 06000, France

Location

MeSH Terms

Conditions

Diabetic Cardiomyopathies

Condition Hierarchy (Ancestors)

CardiomyopathiesHeart DiseasesCardiovascular DiseasesDiabetes ComplicationsDiabetes MellitusEndocrine System Diseases

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
OTHER
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

October 25, 2019

First Posted

October 28, 2019

Study Start

November 24, 2020

Primary Completion

November 1, 2023

Study Completion

December 1, 2023

Last Updated

February 5, 2024

Record last verified: 2024-02

Data Sharing

IPD Sharing
Will not share

Locations

FR(1)