Insulin Resistance Clinical Trial
Official title:
Metformin in the Diastolic Dysfunction of Metabolic Syndrome: MET-DIME Trial
Metabolic syndrome (MS) is a cluster of risk factors for cardiovascular disease with
increasing prevalence worldwide and insulin resistance is central to its pathophysiology and
multi-organ deleterious effects. One of the most affected organs, the heart, undergoes a
remodeling process with an increase in fibrous tissue that impairs global cardiac function.
Considering that myocardial fibrosis increases myocardial stiffness, one important
determinant of diastolic function, it probably contributes decisively to subclinical left
ventricular diastolic dysfunction (DD) and heart failure with preserved ejection fraction in
patients with MS.
Since insulin resistance is a dominant player in the pathophysiology of MS, improvement of
the metabolic profile of these patients with metformin might be associated with favorable
remodeling of myocardial structure and an improvement in myocardial function. Metformin is a
widely used drug to treat type 2 diabetes mellitus and is considered an option in the
treatment of high-risk non-diabetic patients with MS, in addition to lifestyle counseling
including a healthy diet and physical activity.
In this way, we aim to: i) assess if treating non-diabetic patients with MS and DD with
metformin in addition to lifestyle counseling decreases cardiac fibrosis and improves
diastolic function and assess its impact in functional capacity and health-related quality of
life (HRQoL); ii) evaluate if biomarkers of cardiac remodeling and inflammation are
predictive factors of response to metformin treatment in these patients.
This is a prospective, randomized, open-label, blinded-endpoint (PROBE) trial (scheduled
follow-up of 24 months) with 2 arms: lifestyle counseling only and lifestyle counseling plus
metformin (maximum dose of 1000mg twice daily).
The primary endpoint will be change in change in mean of septal and lateral early diastolic
mitral annular velocities (E') (at the end of the 24 months of follow-up).
The secondary endpoints will include a composite of major cardiovascular events; diastolic
function parameters at rest; plasma levels of insulin, glucose, insulin resistance index,
NTproBNP, high-sensitivity C-reactive protein, tumor necrosis factor-α (TNFα), tissue
inhibitor of matrix metalloproteinase type 1 (TIMP1) and growth differentiation factor-15
(GDF-15); functional capacity; epicardial, pericardial and abdominal adipose tissue volumes,
and coronary calcium score; HRQoL.
n/a
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