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
  Purpose

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 Intervention Phase
Diabetes Mellitus
Metabolic Syndrome
Obesity
Atherosclerosis
Procedure: Digestive Adaptations III surgery
Phase 2

Study Type: Observational
Study Design: Observational Model: Case Control
Time Perspective: Prospective
Official Title: Effect of Bariatric Surgery "Digestive Adaptations III" on Clinical, Laboratory and Cardiovascular Risk Factors

Resource links provided by NLM:


Further study details as provided by University of Sao Paulo:

Primary Outcome Measures:
  • 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.


Biospecimen Retention:   Samples Without DNA

Whole blood samples will be retained for future exams.


Estimated Enrollment: 30
Study Start Date: April 2013
Estimated Study Completion Date: April 2016
Estimated Primary Completion Date: April 2015 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
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.
Procedure: Digestive Adaptations III surgery
Other Name: Sleeve gastrectomy with transit bipartition
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.

  Eligibility

Ages Eligible for Study:   18 Years to 65 Years
Genders 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.

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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01581099

Contacts
Contact: Fernanda R Azevedo, Nutr +551126615376 freis@usp.br
Contact: Bruno Caramello, Ph.D. +551126615376 bcaramel@usp.br

Locations
Brazil
Heart Institute - University of São Paulo Recruiting
São Paulo, Brazil, 05403-000
Contact: Bruno Caramelli, Ph.D.    +551126615376    bcaramel@usp.br   
Contact: Fernanda R Azevedo, Nutr    +551126615376    freis@usp.br   
Principal Investigator: Bruno Caramelli, Ph.D.         
Principal Investigator: Fernanda R Azevedo, Nutr         
Sponsors and Collaborators
University of Sao Paulo
Fundação de Amparo à Pesquisa do Estado de São Paulo
Investigators
Study Chair: Bruno Caramelli, Ph.D. University of Sao Paulo
Principal Investigator: Fernanda R Azevedo, Nutr University of Sao Paulo
  More Information

No publications provided

Responsible Party: Bruno Caramelli, Director, Interdisciplinary Medicine in Cardiology Unit, Heart Institute, University of Sao Paulo
ClinicalTrials.gov Identifier: NCT01581099     History of Changes
Other Study ID Numbers: USP - 0355/11
Study First Received: April 17, 2012
Last Updated: November 9, 2013
Health Authority: Brazil: National Committee of Ethics in Research

Keywords provided by University of Sao Paulo:
Atherosclerosis
Cardiovascular risk factors
Calorie restriction
Bariatric Surgery

Additional relevant MeSH terms:
Atherosclerosis
Arteriosclerosis
Diabetes Mellitus
Obesity
Metabolic Syndrome X
Arterial Occlusive Diseases
Vascular Diseases
Cardiovascular Diseases
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases
Overnutrition
Nutrition Disorders
Overweight
Body Weight
Signs and Symptoms
Insulin Resistance
Hyperinsulinism

ClinicalTrials.gov processed this record on August 25, 2014