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Effect of Bariatric Surgery "Digestive Adaptations III" on Cardiovascular Risk (ADIII)

This study is currently recruiting participants. (see Contacts and Locations)
Verified November 2013 by University of Sao Paulo
Sponsor:
Collaborator:
Fundação de Amparo à Pesquisa do Estado de São Paulo
Information provided by (Responsible Party):
Bruno Caramelli, University of Sao Paulo
ClinicalTrials.gov Identifier:
NCT01581099
First received: April 17, 2012
Last updated: November 9, 2013
Last verified: November 2013

April 17, 2012
November 9, 2013
April 2013
April 2015   (final data collection date for primary outcome measure)
Improvement in Metabolic Profile [ Time Frame: two years ] [ Designated as safety issue: No ]
Modification in variables linked to cardiovascular diseases leading to an estimated reduction in cardiovascular risk.
Same as current
Complete list of historical versions of study NCT01581099 on ClinicalTrials.gov Archive Site
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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

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.

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Observational
Observational Model: Case Control
Time Perspective: Prospective
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Retention:   Samples Without DNA
Description:

Whole blood samples will be retained for future exams.

Non-Probability Sample

The population will be selected in a primary care clinic.

  • Diabetes Mellitus
  • Metabolic Syndrome
  • Obesity
  • Atherosclerosis
Procedure: Digestive Adaptations III surgery
Other Name: Sleeve gastrectomy with transit bipartition
  • 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.
    Intervention: Procedure: 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.
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
30
April 2016
April 2015   (final data collection date for primary outcome measure)

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.
Male
18 Years to 65 Years
Yes
Contact: Fernanda R Azevedo, Nutr +551126615376 freis@usp.br
Contact: Bruno Caramello, Ph.D. +551126615376 bcaramel@usp.br
Brazil
 
NCT01581099
USP - 0355/11
No
Bruno Caramelli, University of Sao Paulo
University of Sao Paulo
Fundação de Amparo à Pesquisa do Estado de São Paulo
Study Chair: Bruno Caramelli, Ph.D. University of Sao Paulo
Principal Investigator: Fernanda R Azevedo, Nutr University of Sao Paulo
University of Sao Paulo
November 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP