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: August 3, 2014
Last verified: August 2014
  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
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: 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 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) ] [ 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.


Secondary Outcome Measures:
  • 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.


Estimated Enrollment: 120
Study Start Date: July 2013
Estimated Study Completion Date: December 2014
Estimated Primary Completion Date: December 2014 (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

Ages Eligible for Study:   55 Years to 70 Years
Genders Eligible for Study:   Both
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01863147

Contacts
Contact: Xiang Guangda, MD,PhD 2768878410 ext +86 Guangda64@hotmail.com

Locations
China, Hubei
Guangda Xiang Completed
Wuhan, Hubei, China, 430070
Wuhan General Hospital Recruiting
Wuhan, Hubei, China, 430070
Contact: Xiang Guangda, MD         
Principal Investigator: Xiang Guangda, MD         
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

No publications provided

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
Study First Received: May 21, 2013
Last Updated: August 3, 2014
Health Authority: China: Ethics Committee

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

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

ClinicalTrials.gov processed this record on September 16, 2014