Clinical trial NCT01581099: Effect of Bariatric Surgery "Digestive Adaptations III" on Cardiovascular Risk
Official title: Effect of Bariatric Surgery "Digestive Adaptations III" on Clinical, Laboratory and Cardiovascular Risk Factors
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Diabetes Mellitus
Metabolic Syndrome
Obesity
Atherosclerosis
Keywords: Atherosclerosis
Cardiovascular risk factors
Calorie restriction
Bariatric Surgery
Lead sponsor: University of Sao Paulo
Sponsor class: OTHER
Collaborators: name: Fundação de Amparo à Pesquisa do Estado de São Paulo
First posted: 2012-04-19
Enrollment: 30
Sex: MALE
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: CASE_CONTROL
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: The population will be selected in a primary care clinic.

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.


Eligibility criteria: 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.

Primary outcomes:
measure: Improvement in Metabolic Profile
timeFrame: two years
Secondary outcomes:
Other outcomes:
Locations:
city: São Paulo
country: Brazil
facility: Heart Institute - University of São Paulo
Study officials:
affiliation: University of Sao Paulo
name: Bruno Caramelli, Ph.D.
role: STUDY_CHAIR
affiliation: University of Sao Paulo
name: Fernanda R Azevedo, Nutr
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.