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Sitagliptin Reduces Left Ventricular Mass in Normotensive Type 2 Diabetic Patients With Coronary Artery Disease

Primary Purpose

Newly Diagnosed Type 2 Diabetes, Coronary Artery Disease

Status
Completed
Phase
Phase 4
Locations
China
Study Type
Interventional
Intervention
Sitagliptin and acarbose
Sponsored by
Wuhan General Hospital of Guangzhou Military Command
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Newly Diagnosed Type 2 Diabetes focused on measuring Type 2 diabetes, left ventricular mass, inhibitor of dipeptidyl peptidase-4

Eligibility Criteria

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

Inclusion Criteria:Patients had to have the levels of hemoglobin A1c (HbA1c) > 7.0 %. They also had to have either angiographically documented coronary artery disease or a previous history of myocardial infarction. In addition, they were also required to have an office BP < 135/85 mm Hg and the presence of LVH on echocardiography (American Society of Echocardiography criteria LVM index [LVMI] > 115 g/m2 for men and > 95 g/m2 for women) . -

Exclusion Criteria:Patients were excluded if they were currently prescribed glucagon-like peptide (GLP) -1 analogues or DPP-4 inhibitors or glucosidase inhibitor or anti-hypertensive drugs (including b-blockers), diabetes medications, estrogen supplements, thyroxine, diuretics, hypolipidemic drugs. They 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

  • Guangda Xiang
  • Wuhan General Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Sitagliptin

acarbose

Arm Description

Sitagliptin 0.1 daily for 1 year

acarbose 150mg daily for 1 year

Outcomes

Primary Outcome Measures

Left ventricular mass and left ventricular volume
Cardiac magnetic resonance (CMR) imaging was performed at baseline and at 12 months for left ventricular mass and left ventricular volume.

Secondary Outcome Measures

Endothelial function and augmentation index (AIx)
Endothelial function was assessed on three visits (baseline, month 6, and month 12) by measuring flow-mediated dilation (FMD) of the brachial artery in response to hyperemia according to our previous reports. Pulse wave analysis and pulse wave velocity (PWV) were measured at baseline, 6 months visit, and 12 months visit.

Full Information

First Posted
May 21, 2013
Last Updated
August 15, 2015
Sponsor
Wuhan General Hospital of Guangzhou Military Command
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1. Study Identification

Unique Protocol Identification Number
NCT01863147
Brief Title
Sitagliptin Reduces Left Ventricular Mass in Normotensive Type 2 Diabetic Patients With Coronary Artery Disease
Official Title
Sitagliptin 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
July 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).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 . Sitagliptin, an inhibitor of dipeptidyl peptidase-4 (DPP-4), may regress left ventricular mass (LVM) in newly diagnosed 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
Newly Diagnosed Type 2 Diabetes, Coronary Artery Disease
Keywords
Type 2 diabetes, left ventricular mass, inhibitor of dipeptidyl peptidase-4

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
66 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Sitagliptin
Arm Type
Experimental
Arm Description
Sitagliptin 0.1 daily for 1 year
Arm Title
acarbose
Arm Type
Active Comparator
Arm Description
acarbose 150mg daily for 1 year
Intervention Type
Drug
Intervention Name(s)
Sitagliptin and acarbose
Intervention Description
Sitagliptin group: The intervention drug is sitagliptin. Acarbose group: The intervention drug is acarbose.
Primary Outcome Measure Information:
Title
Left ventricular mass and left ventricular volume
Description
Cardiac magnetic resonance (CMR) imaging was performed at baseline and at 12 months for left ventricular mass and left ventricular volume.
Time Frame
2013~2014(follow up 1 year)
Secondary Outcome Measure Information:
Title
Endothelial function and augmentation index (AIx)
Description
Endothelial function was assessed on three visits (baseline, month 6, and month 12) by measuring flow-mediated dilation (FMD) of the brachial artery in response to hyperemia according to our previous reports. Pulse wave analysis and pulse wave velocity (PWV) were measured at baseline, 6 months visit, and 12 months visit.
Time Frame
2013~2014 (follow up 1 year)

10. Eligibility

Sex
All
Minimum Age & Unit of Time
55 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:Patients had to have the levels of hemoglobin A1c (HbA1c) > 7.0 %. They also had to have either angiographically documented coronary artery disease or a previous history of myocardial infarction. In addition, they were also required to have an office BP < 135/85 mm Hg and the presence of LVH on echocardiography (American Society of Echocardiography criteria LVM index [LVMI] > 115 g/m2 for men and > 95 g/m2 for women) . - Exclusion Criteria:Patients were excluded if they were currently prescribed glucagon-like peptide (GLP) -1 analogues or DPP-4 inhibitors or glucosidase inhibitor or anti-hypertensive drugs (including b-blockers), diabetes medications, estrogen supplements, thyroxine, diuretics, hypolipidemic drugs. They 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. -
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Xiang Guangda, MD,PhD
Organizational Affiliation
Wuhan General Hospital of Guangzhou Command
Official's Role
Study Director
Facility Information:
Facility Name
Guangda Xiang
City
Wuhan
State/Province
Hubei
ZIP/Postal Code
430070
Country
China
Facility Name
Wuhan General Hospital
City
Wuhan
State/Province
Hubei
ZIP/Postal Code
430070
Country
China

12. IPD Sharing Statement

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Sitagliptin Reduces Left Ventricular Mass in Normotensive Type 2 Diabetic Patients With Coronary Artery Disease

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