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

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 .

Study Overview

• Status: Completed
• Conditions: Coronary Artery Disease; Newly Diagnosed Type 2 Diabetes
• Intervention / Treatment: Drug: Sitagliptin and acarbose

• Study Type: Interventional
• Enrollment (Actual): 66
• Phase: Phase 4

Contacts and Locations

Study Locations

• China
  • Hubei
    • Wuhan, Hubei, China, 430070
      • Wuhan General Hospital
    • Wuhan, Hubei, China, 430070
      • Guangda Xiang

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 55 years to 70 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Sitagliptin; Sitagliptin 0.1 daily for 1 year	Drug: Sitagliptin and acarbose; Sitagliptin group: The intervention drug is sitagliptin. Acarbose group: The intervention drug is acarbose.
Active Comparator: acarbose; acarbose 150mg daily for 1 year	Drug: Sitagliptin and acarbose; Sitagliptin group: The intervention drug is sitagliptin. Acarbose group: The intervention drug is acarbose.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	2013~2014(follow up 1 year)

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	2013~2014 (follow up 1 year)

Collaborators and Investigators

• Sponsor: Wuhan General Hospital of Guangzhou Military Command
• Investigators: Study Director: Xiang Guangda, MD,PhD, Wuhan General Hospital of Guangzhou Command

Study record dates

Study Major Dates

• Study Start: July 1, 2013
• Primary Completion (Actual): July 1, 2015
• Study Completion (Actual): July 1, 2015

Study Registration Dates

• First Submitted: May 21, 2013
• First Submitted That Met QC Criteria: May 22, 2013
• First Posted (Estimate): May 27, 2013

Study Record Updates

• Last Update Posted (Estimate): August 18, 2015
• Last Update Submitted That Met QC Criteria: August 15, 2015
• Last Verified: August 1, 2015

More Information

Terms related to this study

• Keywords: Type 2 diabetes; left ventricular mass; inhibitor of dipeptidyl peptidase-4
• Additional Relevant MeSH Terms: Heart Diseases; Cardiovascular Diseases; Vascular Diseases; Glucose Metabolism Disorders; Metabolic Diseases; Arteriosclerosis; Arterial Occlusive Diseases; Endocrine System Diseases; Diabetes Mellitus; Coronary Artery Disease; Myocardial Ischemia; Coronary Disease; Diabetes Mellitus, Type 2; Hypoglycemic Agents; Physiological Effects of Drugs; Molecular Mechanisms of Pharmacological Action; Enzyme Inhibitors; Hormones; Hormones, Hormone Substitutes, and Hormone Antagonists; Protease Inhibitors; Incretins; Dipeptidyl-Peptidase IV Inhibitors; Glycoside Hydrolase Inhibitors; Sitagliptin Phosphate; Acarbose
• Other Study ID Numbers: 2010Wze052