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

This study is currently recruiting participants. (see Contacts and Locations)
Verified August 2014 by Wuhan General Hospital of Guangzhou Military Command
Sponsor:
Information provided by (Responsible Party):
Xiang Guang-da, Wuhan General Hospital of Guangzhou Military Command
ClinicalTrials.gov Identifier:
NCT01863147
First received: May 21, 2013
Last updated: November 4, 2014
Last verified: August 2014

May 21, 2013
November 4, 2014
July 2013
December 2014   (final data collection date for primary outcome measure)
Left ventricular mass and left ventricular volume [ Time Frame: 2013~2014(follow up 1 year) ] [ Designated as safety issue: Yes ]
Cardiac magnetic resonance (CMR) imaging was performed at baseline and at 12 months for left ventricular mass and left ventricular volume.
Left ventricular mass and left ventricular volume [ Time Frame: 2010~2013(follow up 1 year) ] [ Designated as safety issue: Yes ]
Cardiac magnetic resonance (CMR) imaging was performed at baseline and at 12 months for left ventricular mass and left ventricular volume.
Complete list of historical versions of study NCT01863147 on ClinicalTrials.gov Archive Site
Endothelial function and augmentation index (AIx) [ Time Frame: 2013~2014 (follow up 1 year) ] [ Designated as safety issue: Yes ]
  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.
Endothelial function and augmentation index (AIx) [ Time Frame: 2010~2013 (follow up 1 year) ] [ Designated as safety issue: Yes ]
  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.
Not Provided
Not Provided
 
Sitagliptin Reduces Left Ventricular Mass in Normotensive Type 2 Diabetic Patients With Coronary Artery Disease
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 .

Not Provided
Interventional
Phase 4
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
  • Newly Diagnosed Type 2 Diabetes
  • Coronary Artery Disease
Drug: Sitagliptin and acarbose
Sitagliptin group: The intervention drug is sitagliptin. Acarbose group: The intervention drug is acarbose.
  • Experimental: Sitagliptin
    Sitagliptin 0.1 daily for 1 year
    Intervention: Drug: Sitagliptin and acarbose
  • Active Comparator: acarbose
    acarbose 150mg daily for 1 year
    Intervention: Drug: Sitagliptin and acarbose
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
66
December 2014
December 2014   (final data collection date for primary outcome measure)

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. -

Both
55 Years to 70 Years
No
Contact: Xiang Guangda, MD,PhD 2768878410 ext +86 Guangda64@hotmail.com
China
 
NCT01863147
2010Wze052
Yes
Xiang Guang-da, Wuhan General Hospital of Guangzhou Military Command
Wuhan General Hospital of Guangzhou Military Command
Not Provided
Study Director: Xiang Guangda, MD,PhD Wuhan General Hospital of Guangzhou Command
Wuhan General Hospital of Guangzhou Military Command
August 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP