Effect of Bariatric Surgery "Digestive Adaptations III" on Cardiovascular Risk (ADIII)
|ClinicalTrials.gov Identifier: NCT01581099|
Recruitment Status : Completed
First Posted : April 19, 2012
Last Update Posted : May 2, 2017
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.
|Condition or disease||Intervention/treatment|
|Diabetes Mellitus Metabolic Syndrome Obesity Atherosclerosis||Procedure: Digestive Adaptations III surgery|
|Study Type :||Observational|
|Actual Enrollment :||30 participants|
|Official Title:||Effect of Bariatric Surgery "Digestive Adaptations III" on Clinical, Laboratory and Cardiovascular Risk Factors|
|Study Start Date :||April 2013|
|Actual Primary Completion Date :||March 2016|
|Actual Study Completion Date :||April 20, 2017|
Diabetic individuals refractory to medical treatment kept under clinical treatment guidelines and lifestyle
Diabetic individuals refractory to conservative clinical treatment subject to Digestive Adaptations III Surgery.
Procedure: Digestive Adaptations III surgery
Other Name: Sleeve gastrectomy with transit bipartition
Healthy individuals (normal weight and no cardiovascular risk factors) will be used to evaluate the behavior incretin hormones in healthy individuals, serving as a benchmark to analyze the results obtained in other groups.
- Improvement in Metabolic Profile [ Time Frame: two years ]Modification in variables linked to cardiovascular diseases leading to an estimated reduction in cardiovascular risk.
Biospecimen Retention: Samples Without DNA
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01581099
|Heart Institute - University of São Paulo|
|São Paulo, Brazil, 05403-000|
|Study Chair:||Bruno Caramelli, Ph.D.||University of Sao Paulo|
|Principal Investigator:||Fernanda R Azevedo, Nutr||University of Sao Paulo|