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Clinical Trials/NCT01877590
NCT01877590
Completed
Phase 4

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

Wuhan General Hospital of Guangzhou Military Command1 site in 1 country66 target enrollmentNovember 2013

Overview

Phase
Phase 4
Intervention
alpha-lipoic acid
Conditions
Type 2 Diabetes
Sponsor
Wuhan General Hospital of Guangzhou Military Command
Enrollment
66
Locations
1
Primary Endpoint
Alpha-lipoic acid regress the left ventricular mass
Status
Completed
Last Updated
10 years ago

Overview

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.

Registry
clinicaltrials.gov
Start Date
November 2013
End Date
July 2015
Last Updated
10 years ago
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Sponsor
Wuhan General Hospital of Guangzhou Military Command
Responsible Party
Principal Investigator
Principal Investigator

Xiang Guang-da

Director of Endocrinol Dept.

Wuhan General Hospital of Guangzhou Military Command

Eligibility Criteria

Inclusion Criteria

  • Type 2 diabetes
  • 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.

Arms & Interventions

alpha-lipoic acid group

alpha-lipoic acid 600 mg daily for one year.

Intervention: alpha-lipoic acid

Outcomes

Primary Outcomes

Alpha-lipoic acid regress the left ventricular mass

Time Frame: one year

Alpha-lipoic acid 600 mg daily for one year.

Secondary Outcomes

  • The change of endothelial dysfunction before and after alpha-lipoic acid intervention.(one year)

Study Sites (1)

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