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

Obesity Clinical Trial

— ADIII  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01581099
• Other study ID #: USP - 0355/11
• Status: Completed
• Phase: N/A
• First received: April 17, 2012
• Last updated: May 1, 2017
• Start date: April 2013
• Est. completion date: April 20, 2017

Study information

• Verified date: May 2017
• Source: University of Sao Paulo
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 30
• Est. completion date: April 20, 2017
• Est. primary completion date: March 2016
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Male
• Age group: 18 Years to 65 Years

Eligibility

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.

Related Conditions & MeSH terms

• Atherosclerosis
• Diabetes Mellitus
• Metabolic Syndrome
• Metabolic Syndrome X
• Obesity

Intervention

Procedure:
• Digestive Adaptations III surgery

Locations

Country	Name	City	State
Brazil	Heart Institute - University of São Paulo	São Paulo

Sponsors (2)

Lead Sponsor	Collaborator
University of Sao Paulo	Fundação de Amparo à Pesquisa do Estado de São Paulo

Country where clinical trial is conducted

Brazil, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Improvement in Metabolic Profile	Modification in variables linked to cardiovascular diseases leading to an estimated reduction in cardiovascular risk.	two years