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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

Status
Completed
Phases
Phase 4
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT01863147
Enrollment
66
Registered
2013-05-27
Start date
2013-07-31
Completion date
2015-07-31
Last updated
2015-08-18

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Coronary Artery Disease, Newly Diagnosed Type 2 Diabetes

Keywords

Type 2 diabetes, left ventricular mass, inhibitor of dipeptidyl peptidase-4

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 .

Interventions

Sitagliptin group: The intervention drug is sitagliptin. Acarbose group: The intervention drug is acarbose.

Sponsors

Wuhan General Hospital of Guangzhou Military Command
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
55 Years to 70 Years
Healthy volunteers
No

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. -

Design outcomes

Primary

MeasureTime frameDescription
Left ventricular mass and left ventricular volume2013~2014(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

MeasureTime frameDescription
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.

Countries

China

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026