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Effect of Bariatric Surgery Digestive Adaptations III on Cardiovascular Risk

Effect of Bariatric Surgery Digestive Adaptations III on Clinical, Laboratory and Cardiovascular Risk Factors

Status
Completed
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT01581099
Acronym
ADIII
Enrollment
30
Registered
2012-04-19
Start date
2013-04-30
Completion date
2017-04-20
Last updated
2017-05-02

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Atherosclerosis, Diabetes Mellitus, Metabolic Syndrome, Obesity

Keywords

Atherosclerosis, Cardiovascular risk factors, Calorie restriction, Bariatric Surgery

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.

Interventions

PROCEDUREDigestive Adaptations III surgery

Sponsors

Fundação de Amparo à Pesquisa do Estado de São Paulo
CollaboratorOTHER_GOV
University of Sao Paulo
Lead SponsorOTHER

Study design

Observational model
CASE_CONTROL
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
MALE
Age
18 Years to 65 Years
Healthy volunteers
Yes

Inclusion criteria

* 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.

Exclusion criteria

* 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.

Design outcomes

Primary

MeasureTime frameDescription
Improvement in Metabolic Profiletwo yearsModification in variables linked to cardiovascular diseases leading to an estimated reduction in cardiovascular risk.

Countries

Brazil

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026