Description Module
The Description Module contains narrative descriptions of the clinical trial, including a brief summary and detailed description. These descriptions provide important information about the study's purpose, methodology, and key details in language accessible to both researchers and the general public.
Description Module path is as follows:
Study -> Protocol Section -> Description Module
Description Module
Ignite Creation Date:
2025-12-24 @ 4:31 PM
Ignite Modification Date:
2025-12-24 @ 4:31 PM
NCT ID:
NCT01353066
Brief Summary:
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
Study:
NCT01353066
Study Brief:
Protocol Section:
NCT01353066