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.
Studienübersicht
Status
Intervention / Behandlung
Studientyp
Einschreibung (Tatsächlich)
Kontakte und Standorte
Studienorte
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São Paulo, Brasilien, 05403-000
- Heart Institute - University of Sao Paulo
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Teilnahmekriterien
Zulassungskriterien
Studienberechtigtes Alter
Akzeptiert gesunde Freiwillige
Studienberechtigte Geschlechter
Probenahmeverfahren
Studienpopulation
Beschreibung
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.
Studienplan
Wie ist die Studie aufgebaut?
Designdetails
Kohorten und Interventionen
Gruppe / Kohorte |
Intervention / Behandlung |
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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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Andere Namen:
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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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Was misst die Studie?
Primäre Ergebnismessungen
Ergebnis Maßnahme |
Maßnahmenbeschreibung |
Zeitfenster |
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Improvement in Metabolic Profile
Zeitfenster: 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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Mitarbeiter und Ermittler
Sponsor
Ermittler
- Studienstuhl: Bruno Caramelli, Ph.D., University of Sao Paulo
- Hauptermittler: Fernanda R Azevedo, Nutr, University of Sao Paulo
Publikationen und hilfreiche Links
Studienaufzeichnungsdaten
Haupttermine studieren
Studienbeginn
Primärer Abschluss (Tatsächlich)
Studienabschluss (Tatsächlich)
Studienanmeldedaten
Zuerst eingereicht
Zuerst eingereicht, das die QC-Kriterien erfüllt hat
Zuerst gepostet (Schätzen)
Studienaufzeichnungsaktualisierungen
Letztes Update gepostet (Tatsächlich)
Letztes eingereichtes Update, das die QC-Kriterien erfüllt
Zuletzt verifiziert
Mehr Informationen
Begriffe im Zusammenhang mit dieser Studie
Schlüsselwörter
Zusätzliche relevante MeSH-Bedingungen
Andere Studien-ID-Nummern
- USP - 0355/11
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