Effect of Bariatric Surgery "Digestive Adaptations III" on Cardiovascular Risk (ADIII)
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.
Panoramica dello studio
Stato
Condizioni
Intervento / Trattamento
Tipo di studio
Iscrizione (Effettivo)
Contatti e Sedi
Luoghi di studio
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São Paulo, Brasile, 05403-000
- Heart Institute - University of São Paulo
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Criteri di partecipazione
Criteri di ammissibilità
Età idonea allo studio
Accetta volontari sani
Sessi ammissibili allo studio
Metodo di campionamento
Popolazione di studio
Descrizione
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.
Piano di studio
Come è strutturato lo studio?
Dettagli di progettazione
Coorti e interventi
Gruppo / Coorte |
Intervento / Trattamento |
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Clinical treatment
Diabetic individuals refractory to medical treatment kept under clinical treatment guidelines and lifestyle
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Surgery
Diabetic individuals refractory to conservative clinical treatment subject to Digestive Adaptations III Surgery.
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Altri nomi:
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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.
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Cosa sta misurando lo studio?
Misure di risultato primarie
Misura del risultato |
Misura Descrizione |
Lasso di tempo |
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Improvement in Metabolic Profile
Lasso di tempo: two years
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Modification in variables linked to cardiovascular diseases leading to an estimated reduction in cardiovascular risk.
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two years
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Collaboratori e investigatori
Sponsor
Collaboratori
Investigatori
- Cattedra di studio: Bruno Caramelli, Ph.D., University of Sao Paulo
- Investigatore principale: Fernanda R Azevedo, Nutr, University of Sao Paulo
Pubblicazioni e link utili
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Inizio studio
Completamento primario (Effettivo)
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Date di iscrizione allo studio
Primo inviato
Primo inviato che soddisfa i criteri di controllo qualità
Primo Inserito (Stima)
Aggiornamenti dei record di studio
Ultimo aggiornamento pubblicato (Effettivo)
Ultimo aggiornamento inviato che soddisfa i criteri QC
Ultimo verificato
Maggiori informazioni
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Parole chiave
Termini MeSH pertinenti aggiuntivi
Altri numeri di identificazione dello studio
- USP - 0355/11
Queste informazioni sono state recuperate direttamente dal sito web clinicaltrials.gov senza alcuna modifica. In caso di richieste di modifica, rimozione o aggiornamento dei dettagli dello studio, contattare register@clinicaltrials.gov. Non appena verrà implementata una modifica su clinicaltrials.gov, questa verrà aggiornata automaticamente anche sul nostro sito web .