Alpha-lipoic Acid Reduces Left Ventricular Mass in Normotensive Type 2 Diabetic Patients With Coronary Artery Disease

Phase 4

Completed

• Conditions: Left Ventricular Mass; Type 2 Diabetes; Coronary Artery Disease
• Interventions: Drug: alpha-lipoic acid

• Registration Number: NCT01877590
• Lead Sponsor: Wuhan General Hospital of Guangzhou Military Command

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2013-06-11
• Study First Submitted QC: 2013-06-12
• Study First Posted: 2013-06-13
• Study Start: 2013-11
• Primary Completion: 2015-07
• Study Completion: 2015-07
• Status Verified: 2015-08
• Last Update Submitted: 2015-08-19
• Last Update Posted: 2015-08-21

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 66

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
alpha-lipoic acid group	alpha-lipoic acid	alpha-lipoic acid 600 mg daily for one year.

Primary Outcome Measures

Name	Time	Method
Alpha-lipoic acid regress the left ventricular mass	one year	Alpha-lipoic acid 600 mg daily for one year.

Secondary Outcome Measures

Name	Time	Method
The change of endothelial dysfunction before and after alpha-lipoic acid intervention.	one year

Trial Locations

Locations (1)

Wuhan General Hospital; 🇨🇳 Wuhan, Hubei, China