Alpha-lipoic Acid Reduces Left Ventricular Mass in Normotensive Type 2 Diabetic Patients With Coronary Artery Disease
Primary Purpose
Type 2 Diabetes, Coronary Artery Disease, Left Ventricular Mass
Status
Completed
Phase
Phase 4
Locations
China
Study Type
Interventional
Intervention
alpha-lipoic acid
Sponsored by
About this trial
This is an interventional prevention trial for Type 2 Diabetes
Eligibility Criteria
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.
Sites / Locations
- Wuhan General Hospital
Arms of the Study
Arm 1
Arm 2
Arm Type
Placebo Comparator
Experimental
Arm Label
placebo group
alpha-lipoic acid group
Arm Description
An identical placebo daily
alpha-lipoic acid 600 mg daily for one year.
Outcomes
Primary Outcome Measures
Alpha-lipoic acid regress the left ventricular mass
Alpha-lipoic acid 600 mg daily for one year.
Secondary Outcome Measures
The change of endothelial dysfunction before and after alpha-lipoic acid intervention.
Full Information
NCT ID
NCT01877590
First Posted
June 11, 2013
Last Updated
August 19, 2015
Sponsor
Wuhan General Hospital of Guangzhou Military Command
1. Study Identification
Unique Protocol Identification Number
NCT01877590
Brief Title
Alpha-lipoic Acid Reduces Left Ventricular Mass in Normotensive Type 2 Diabetic Patients With Coronary Artery Disease
Official Title
Alpha-lipoic Acid Reduces Left Ventricular Mass in Normotensive Type 2 Diabetic Patients With Coronary Artery Disease
Study Type
Interventional
2. Study Status
Record Verification Date
August 2015
Overall Recruitment Status
Completed
Study Start Date
November 2013 (undefined)
Primary Completion Date
July 2015 (Actual)
Study Completion Date
July 2015 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Wuhan General Hospital of Guangzhou Military Command
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Type 2 Diabetes, Coronary Artery Disease, Left Ventricular Mass
7. Study Design
Primary Purpose
Prevention
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
66 (Actual)
8. Arms, Groups, and Interventions
Arm Title
placebo group
Arm Type
Placebo Comparator
Arm Description
An identical placebo daily
Arm Title
alpha-lipoic acid group
Arm Type
Experimental
Arm Description
alpha-lipoic acid 600 mg daily for one year.
Intervention Type
Drug
Intervention Name(s)
alpha-lipoic acid
Primary Outcome Measure Information:
Title
Alpha-lipoic acid regress the left ventricular mass
Description
Alpha-lipoic acid 600 mg daily for one year.
Time Frame
one year
Secondary Outcome Measure Information:
Title
The change of endothelial dysfunction before and after alpha-lipoic acid intervention.
Time Frame
one year
10. Eligibility
Sex
All
Minimum Age & Unit of Time
40 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Facility Information:
Facility Name
Wuhan General Hospital
City
Wuhan
State/Province
Hubei
ZIP/Postal Code
430070
Country
China
12. IPD Sharing Statement
Learn more about this trial
Alpha-lipoic Acid Reduces Left Ventricular Mass in Normotensive Type 2 Diabetic Patients With Coronary Artery Disease
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