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

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01863147
First Posted: May 27, 2013
Last Update Posted: August 18, 2015
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
Xiang Guang-da, Wuhan General Hospital of Guangzhou Military Command
  Purpose

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 .


Condition Intervention Phase
Newly Diagnosed Type 2 Diabetes Coronary Artery Disease Drug: Sitagliptin and acarbose Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Sitagliptin Reduces Left Ventricular Mass in Normotensive Type 2 Diabetic Patients With Coronary Artery Disease

Resource links provided by NLM:


Further study details as provided by Xiang Guang-da, Wuhan General Hospital of Guangzhou Military Command:

Primary Outcome Measures:
  • 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 Outcome Measures:
  • Endothelial function and augmentation index (AIx) [ Time Frame: 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.


Enrollment: 66
Study Start Date: July 2013
Study Completion Date: July 2015
Primary Completion Date: July 2015 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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.

  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   55 Years to 70 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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. -

  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01863147


Locations
China, Hubei
Guangda Xiang
Wuhan, Hubei, China, 430070
Wuhan General Hospital
Wuhan, Hubei, China, 430070
Sponsors and Collaborators
Wuhan General Hospital of Guangzhou Military Command
Investigators
Study Director: Xiang Guangda, MD,PhD Wuhan General Hospital of Guangzhou Command
  More Information

Responsible Party: Xiang Guang-da, director, Wuhan General Hospital of Guangzhou Military Command
ClinicalTrials.gov Identifier: NCT01863147     History of Changes
Other Study ID Numbers: 2010Wze052
First Submitted: May 21, 2013
First Posted: May 27, 2013
Last Update Posted: August 18, 2015
Last Verified: August 2015

Keywords provided by Xiang Guang-da, Wuhan General Hospital of Guangzhou Military Command:
Type 2 diabetes
left ventricular mass
inhibitor of dipeptidyl peptidase-4

Additional relevant MeSH terms:
Diabetes Mellitus, Type 2
Coronary Artery Disease
Myocardial Ischemia
Coronary Disease
Diabetes Mellitus
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases
Heart Diseases
Cardiovascular Diseases
Arteriosclerosis
Arterial Occlusive Diseases
Vascular Diseases
Sitagliptin Phosphate
Acarbose
Hypoglycemic Agents
Physiological Effects of Drugs
Incretins
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists
Dipeptidyl-Peptidase IV Inhibitors
Protease Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Glycoside Hydrolase Inhibitors