Alpha-lipoic Acid Reduces Left Ventricular Mass in Normotensive Type 2 Diabetic Patients With Coronary Artery Disease
1 other identifier
interventional
66
1 country
1
Brief Summary
Cardiovascular complications account for the highest mortality in type 2 diabetic patients, mainly due to coronary artery disease (CAD). Most of the attention in treating CAD in type 2 diabetes is understandably directed toward treating coronary artery conditions. However there are other treatable culprits in these patients. Left ventricular hypertrophy (LVH) is widespread in type 2 diabetic patients with CAD, even in the absence of hypertension. It is a strong predictor of cardiovascular events and all-cause mortality. Regression of LVH has been associated with an improved prognosis, independent of change in blood pressure (BP). Therefore, cardiovascular events and mortality in type 2 diabetes with CAD might will be reduced if the investigators can find novel therapies to regress LVH. Alpha-lipoic acid reduces oxidative stress which then regresses LVH. Alpha-lipoic acid can improve endothelial function in diabetic conditions. Hence, the main aim of this study was to assess whether alpha-lipoic acid could regress LVM in type 2 diabetic patients with CAD.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for phase_4 type-2-diabetes
Started Nov 2013
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
June 11, 2013
CompletedFirst Posted
Study publicly available on registry
June 13, 2013
CompletedStudy Start
First participant enrolled
November 1, 2013
CompletedPrimary Completion
Last participant's last visit for primary outcome
July 1, 2015
CompletedStudy Completion
Last participant's last visit for all outcomes
July 1, 2015
CompletedAugust 21, 2015
August 1, 2015
1.7 years
June 11, 2013
August 19, 2015
Conditions
Outcome Measures
Primary Outcomes (1)
Alpha-lipoic acid regress the left ventricular mass
Alpha-lipoic acid 600 mg daily for one year.
one year
Secondary Outcomes (1)
The change of endothelial dysfunction before and after alpha-lipoic acid intervention.
one year
Study Arms (2)
placebo group
PLACEBO COMPARATORAn identical placebo daily
alpha-lipoic acid group
EXPERIMENTALalpha-lipoic acid 600 mg daily for one year.
Interventions
Eligibility Criteria
You may qualify if:
- Type 2 diabetes
- CAD
- Left ventricular hypertrophy
- HbA1c below 7.0%
- blood pressure \<130/80 mmHg
You may not qualify if:
- Patients were excluded if they were currently alpha-lipoic acid for one year, had a previous adverse reaction to alpha-lipoic acid.
- hey were also excluded if they had renal and liver dysfunction, heart failure, or malignancy, or were unable to give informed consent.
- Patients with contraindications to cardiac magnetic resonance (CMR) (pacemakers, claustrophobia) were also excluded, as were pregnant or lactating women.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Wuhan General Hospital
Wuhan, Hubei, 430070, China
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Design
- Study Type
- interventional
- Phase
- phase 4
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Who Masked
- PARTICIPANT, INVESTIGATOR
- Purpose
- PREVENTION
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Director of Endocrinol Dept.
Study Record Dates
First Submitted
June 11, 2013
First Posted
June 13, 2013
Study Start
November 1, 2013
Primary Completion
July 1, 2015
Study Completion
July 1, 2015
Last Updated
August 21, 2015
Record last verified: 2015-08