Atherosclerotic Cardiovascular Disease Clinical Trial
Official title:
Multicenter Randomized Prospective Trial on the Effects of Intensive Medical Treatment of Type 2 Diabetes With and Without Roux-in-Y Gastric Bypass Surgery on Carotid Intima Media Thickness in Grade I Obesity (BMI 30,0-34,9 kg/m2)
Background: Type 2 Diabetes Mellitus (T2DM) is associated with an increased burden for
cardiovascular disease (CVD). Multifactorial interventions are necessary to reduce the CV
risk in T2DM. Bariatric surgery appears to be an alternative for the multifactorial
intervention in T2DM associated with obesity. Data have shown, that clinical trial aiming at
the control of CVRF in T2DM may not translate in the reduction of CV events.
Hypothesis: Intensive medical treatment (IMM) including Roux-en-Y Gastric Bypass (RYGBP)
could be superior in the control of the progression of subclinical atherosclerotic disease,
as evaluated by carotid ultrasound, in subjects with T2DM and a BMI between 30.0 and 34.9
kg/m2.The primary aim of the study is To compare the effects of intensive medical treatment
(IMM) including Roux-en-Y Gastric Bypass (RYGBP) and IMM alone on the progression of the
carotid intima media thickness (CIMT) at 24 months after entry into the trial relative to
baseline.Methodology: Two-year Randomized Clinical Trial, including 240 patients
n/a
Primary Purpose: Treatment
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