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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
Wuhan General Hospital of Guangzhou Military Command
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Type 2 Diabetes

Eligibility Criteria

40 Years - 70 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

First Posted
June 11, 2013
Last Updated
August 19, 2015
Sponsor
Wuhan General Hospital of Guangzhou Military Command
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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

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

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