Type 2 Diabetes, Coronary Artery Disease, Left Ventricular Mass
Conditions
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.
Interventions
Sponsors
Wuhan General Hospital of Guangzhou Military Command
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
DOUBLE (Subject, Investigator)
Eligibility
Sex/Gender
ALL
Age
40 Years to 70 Years
Healthy volunteers
No
Inclusion criteria
* Type 2 diabetes * CAD * Left ventricular hypertrophy * HbA1c below 7.0% * blood pressure \<130/80 mmHg
Exclusion criteria
* 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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Alpha-lipoic acid regress the left ventricular mass | one year | Alpha-lipoic acid 600 mg daily for one year. |
Secondary
| Measure | Time frame |
|---|---|
| The change of endothelial dysfunction before and after alpha-lipoic acid intervention. | one year |
Countries
China
Outcome results
None listed