Effect of Bariatric Surgery "Digestive Adaptations III" on Cardiovascular Risk (ADIII)
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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.
| 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 |
- 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 2012 |
| Estimated Study Completion Date: | December 2015 |
| Estimated Primary Completion Date: | April 2015 (Final data collection date for primary outcome measure) |
| Groups/Cohorts |
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Diabetic Group - Clinical treatement
Diabetic individuals refractory to medical treatment kept under clinical treatment guidelines and lifestyle
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Diabetic Group - Digestive Adaptations III
Diabetic individuals refractory to conservative clinical treatment subject to Digestive Adaptations III Surgery.
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Healthy Individuals
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.
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Eligibility| Ages Eligible for Study: | 18 Years to 65 Years |
| Genders Eligible for Study: | Male |
| Accepts Healthy Volunteers: | Yes |
| Sampling Method: | Non-Probability Sample |
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.
Contacts and Locations| Contact: Fernanda R Azevedo, Nutr | +551126615376 | freis@usp.br |
| Contact: Bruno Caramello, Ph.D. | +551126615376 | bcaramel@usp.br |
| Brazil | |
| Heart Institute - University of São Paulo | Not yet 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 | |
| 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: | April 17, 2012 |
| Health Authority: | Brazil: National Committee of Ethics in Research |
Keywords provided by University of Sao Paulo:
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Atherosclerosis Cardiovascular risk factors Calorie restriction Bariatric Surgery |
Additional relevant MeSH terms:
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Atherosclerosis Diabetes Mellitus Obesity Metabolic Syndrome X Arteriosclerosis 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 June 17, 2013