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

Coronary Artery Disease Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01877590
• Other study ID #: 2013Wze029
• Status: Completed
• Phase: Phase 4
• First received: June 11, 2013
• Last updated: August 19, 2015
• Start date: November 2013
• Est. completion date: July 2015

Study information

• Verified date: August 2015
• Source: Wuhan General Hospital of Guangzhou Military Command
• Contact: n/a
• Is FDA regulated: No
• Health authority: China: Ethics Committee
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 66
• Est. completion date: July 2015
• Est. primary completion date: July 2015
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 40 Years to 70 Years

Eligibility

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

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Prevention

Related Conditions & MeSH terms

• Coronary Artery Disease
• Coronary Disease
• Left Ventricular Mass
• Myocardial Ischemia
• Type 2 Diabetes

Intervention

Drug:
• alpha-lipoic acid

Locations

Country	Name	City	State
China	Wuhan General Hospital	Wuhan	Hubei

Sponsors (1)

Lead Sponsor	Collaborator
Wuhan General Hospital of Guangzhou Military Command

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Alpha-lipoic acid regress the left ventricular mass	Alpha-lipoic acid 600 mg daily for one year.	one year	Yes
Secondary	The change of endothelial dysfunction before and after alpha-lipoic acid intervention.		one year	Yes