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Clinical Trials/NCT01863147
NCT01863147
Completed
Phase 4

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

Wuhan General Hospital of Guangzhou Military Command2 sites in 1 country66 target enrollmentJuly 2013

Overview

Phase
Phase 4
Intervention
Sitagliptin and acarbose
Conditions
Newly Diagnosed Type 2 Diabetes
Sponsor
Wuhan General Hospital of Guangzhou Military Command
Enrollment
66
Locations
2
Primary Endpoint
Left ventricular mass and left ventricular volume
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).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 .

Registry
clinicaltrials.gov
Start Date
July 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

Wuhan General Hospital of Guangzhou Military Command

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. -

Arms & Interventions

Sitagliptin

Sitagliptin 0.1 daily for 1 year

Intervention: Sitagliptin and acarbose

acarbose

acarbose 150mg daily for 1 year

Intervention: Sitagliptin and acarbose

Outcomes

Primary Outcomes

Left ventricular mass and left ventricular volume

Time Frame: 2013~2014(follow up 1 year)

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

Secondary Outcomes

  • Endothelial function and augmentation index (AIx)(2013~2014 (follow up 1 year))

Study Sites (2)

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