Obesity Clinical Trial - Effect of Bariatric Surgery "Digestive

Status Completed

Clinical Trial Summary

Introduction- Primary prevention is the main strategy to control the global burden of cardiovascular disease. In clinical practice, food restriction represents a valuable preventive resource. However, low adhesion rates and diet abandonment are considered important obstacles in treatment. Considering the discovery of new markers and mechanisms that relate food restriction and to all other cardiovascular risk factors, it is possible and necessary to seek for efficient alternatives to increase adherence and effectiveness of the preventive dietetic treatment. Surgical procedures can be used as a mechanism to promote food restriction. The bariatric surgery have gained importance not only for its potential application in obesity treatment but also in the control of cardiovascular risk factors refractory to medical treatment. Among bariatric operations, there is a group called digestive adaptations III that has specific characteristics.This surgical intervention modifies intestinal tract by reducing gastric volume and performing an anastomosis between ileum and stomach, creating a bipartition in the gut. This structural modification promotes satiety and increased insulin sensitivity more intensely than other surgical strategies. The effects of Digestive Adaptation III surgery on cardiovascular risk factors and on markers related to the development of atherosclerosis are not yet established.

Objectives - To investigate the effect of Digestive Adaptation III surgery on clinical and laboratory parameters and cardiovascular risk factors.

Methods - Twenty diabetics volunteers refractory to medical treatment and who have abdominal obesity will be included in the study. Of this group, half will be randomly selected to perform the Digestive Adaptations III surgery. All participants will undergo clinical and biochemical tests on the same occasions, up to thirty days before surgery, three twenty-four months after surgery. On these occasions besides the lipid profile and glucose, we will determine incretin hormones, adipokines and assess the amount of epicardial fat.

Clinical Trial Description

n/a

Study Design

Related Conditions & MeSH terms

Clinical Trial Details

NCT number	NCT01581099
Study type	Observational
Source	University of Sao Paulo
Contact
Status	Completed
Phase	N/A
Start date	April 2013
Completion date	April 20, 2017

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Clinical trials are conducted in a series of steps, called phases - each phase is designed to answer a separate research question.

Phase 1: Researchers test a new drug or treatment in a small group of people for the first time to evaluate its safety, determine a safe dosage range, and identify side effects.
Phase 2: The drug or treatment is given to a larger group of people to see if it is effective and to further evaluate its safety.
Phase 3: The drug or treatment is given to large groups of people to confirm its effectiveness, monitor side effects, compare it to commonly used treatments, and collect information that will allow the drug or treatment to be used safely.
Phase 4: Studies are done after the drug or treatment has been marketed to gather information on the drug's effect in various populations and any side effects associated with long-term use.

Effect of Bariatric Surgery "Digestive Adaptations III" on Cardiovascular Risk — ADIII

Clinical Trial Summary

Clinical Trial Description

Study Design

Related Conditions & MeSH terms