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

Phase 4

Completed

• Conditions: Newly Diagnosed Type 2 Diabetes; Coronary Artery Disease
• Interventions: Drug: Sitagliptin and acarbose

• Registration Number: NCT01863147
• Lead Sponsor: Wuhan General Hospital of Guangzhou Military Command

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 .

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2013-05-21
• Study First Submitted QC: 2013-05-22
• Study First Posted: 2013-05-27
• Study Start: 2013-07
• Primary Completion: 2015-07
• Study Completion: 2015-07
• Status Verified: 2015-08
• Last Update Submitted: 2015-08-15
• Last Update Posted: 2015-08-18

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 66

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. -

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
acarbose	Sitagliptin and acarbose	acarbose 150mg daily for 1 year
Sitagliptin	Sitagliptin and acarbose	Sitagliptin 0.1 daily for 1 year

Primary Outcome Measures

Name	Time	Method
Left ventricular mass and left ventricular volume	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 Outcome Measures

Name	Time	Method
Endothelial function and augmentation index (AIx)	2013~2014 (follow up 1 year)	1. 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.; 2. Pulse wave analysis and pulse wave velocity (PWV) were measured at baseline, 6 months visit, and 12 months visit.

Trial Locations

Locations (2)

Wuhan General Hospital; 🇨🇳 Wuhan, Hubei, China

Guangda Xiang; 🇨🇳 Wuhan, Hubei, China