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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01581099
Recruitment Status : Completed
First Posted : April 19, 2012
Last Update Posted : May 2, 2017
Fundação de Amparo à Pesquisa do Estado de São Paulo
Information provided by (Responsible Party):
Bruno Caramelli, University of Sao Paulo

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.

Condition or disease Intervention/treatment
Diabetes Mellitus Metabolic Syndrome Obesity Atherosclerosis Procedure: Digestive Adaptations III surgery

Study Type : Observational
Actual Enrollment : 30 participants
Observational Model: Case-Control
Time Perspective: Prospective
Official Title: Effect of Bariatric Surgery "Digestive Adaptations III" on Clinical, Laboratory and Cardiovascular Risk Factors
Study Start Date : April 2013
Actual Primary Completion Date : March 2016
Actual Study Completion Date : April 20, 2017

Resource links provided by the National Library of Medicine

Group/Cohort Intervention/treatment
Clinical treatment
Diabetic individuals refractory to medical treatment kept under clinical treatment guidelines and lifestyle
Diabetic individuals refractory to conservative clinical treatment subject to Digestive Adaptations III Surgery.
Procedure: Digestive Adaptations III surgery
Other Name: Sleeve gastrectomy with transit bipartition

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.

Primary Outcome Measures :
  1. Improvement in Metabolic Profile [ Time Frame: two years ]
    Modification in variables linked to cardiovascular diseases leading to an estimated reduction in cardiovascular risk.

Biospecimen Retention:   Samples Without DNA
Whole blood samples will be retained for future exams.

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Ages Eligible for Study:   18 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   Male
Accepts Healthy Volunteers:   Yes
Sampling Method:   Non-Probability Sample
Study Population
The population will be selected in a primary care clinic.

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT01581099

Heart Institute - University of São Paulo
São Paulo, Brazil, 05403-000
Sponsors and Collaborators
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

Responsible Party: Bruno Caramelli, Director, Interdisciplinary Medicine in Cardiology Unit, Heart Institute, University of Sao Paulo Identifier: NCT01581099     History of Changes
Other Study ID Numbers: USP - 0355/11
First Posted: April 19, 2012    Key Record Dates
Last Update Posted: May 2, 2017
Last Verified: May 2017

Keywords provided by Bruno Caramelli, University of Sao Paulo:
Cardiovascular risk factors
Calorie restriction
Bariatric Surgery

Additional relevant MeSH terms:
Diabetes Mellitus
Metabolic Syndrome X
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases
Insulin Resistance
Arterial Occlusive Diseases
Vascular Diseases
Cardiovascular Diseases