Effect of Bariatric Surgery "Digestive Adaptations III" on Cardiovascular Risk
ADIII
1 other identifier
observational
30
1 country
1
Brief 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for all trials
Started Apr 2013
Longer than P75 for all trials
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
April 17, 2012
CompletedFirst Posted
Study publicly available on registry
April 19, 2012
CompletedStudy Start
First participant enrolled
April 1, 2013
CompletedPrimary Completion
Last participant's last visit for primary outcome
March 1, 2016
CompletedStudy Completion
Last participant's last visit for all outcomes
April 20, 2017
CompletedMay 2, 2017
May 1, 2017
2.9 years
April 17, 2012
May 1, 2017
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Improvement in Metabolic Profile
Modification in variables linked to cardiovascular diseases leading to an estimated reduction in cardiovascular risk.
two years
Study Arms (3)
Clinical treatment
Diabetic individuals refractory to medical treatment kept under clinical treatment guidelines and lifestyle
Surgery
Diabetic individuals refractory to conservative clinical treatment subject to Digestive Adaptations III Surgery.
Control
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.
Interventions
Eligibility Criteria
The population will be selected in a primary care clinic.
You may qualify if:
- Men.
- Adults (raging from 18 to 65 years).
- Ability to understand the procedure, risks and alternatives.
- Patients with BMI \> 28 Kg/m2 and \< 35 Kg/m2 presenting type 2 diabetes diagnosed for more than two years and less than 10 years.
- Glycated hemoglobin\> 8% despite dietary and medical treatment that already includes the use of exogenous insulin
- Waist circumference \> 102 cm.
You may not qualify if:
- Chronic diseases not related to severe obesity.
- Pregnancy.
- Peptide C \<1.5 ng / mL or a positive anti-islet antibodies, anti-GAD or anti-ICA512.
- Previous cancer, unless deemed cured (after 5 years of treatment, at least)
- Acute infection or chronic relevant.
- Alcohol addiction.
- Tobacco use.
- Drug addiction, except those recovered for more than three years.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Heart Institute - University of São Paulo
São Paulo, 05403-000, Brazil
Related Publications (1)
Azevedo FR, Santoro S, Correa-Giannella ML, Toyoshima MT, Giannella-Neto D, Calderaro D, Gualandro DM, Yu PC, Caramelli B. A Prospective Randomized Controlled Trial of the Metabolic Effects of Sleeve Gastrectomy with Transit Bipartition. Obes Surg. 2018 Oct;28(10):3012-3019. doi: 10.1007/s11695-018-3239-3.
PMID: 29704228DERIVED
Biospecimen
Whole blood samples will be retained for future exams.
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- STUDY CHAIR
Bruno Caramelli, Ph.D.
University of Sao Paulo
- PRINCIPAL INVESTIGATOR
Fernanda R Azevedo, Nutr
University of Sao Paulo
Study Design
- Study Type
- observational
- Observational Model
- CASE CONTROL
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Director, Interdisciplinary Medicine in Cardiology Unit, Heart Institute
Study Record Dates
First Submitted
April 17, 2012
First Posted
April 19, 2012
Study Start
April 1, 2013
Primary Completion
March 1, 2016
Study Completion
April 20, 2017
Last Updated
May 2, 2017
Record last verified: 2017-05