Fernanda R Azevedo1, Sergio Santoro2, Maria L Correa-Giannella3,4, Marcos T Toyoshima5, Daniel Giannella-Neto4, Daniela Calderaro1, Danielle M Gualandro1, Pai C Yu1, Bruno Caramelli6. 1. Unidade de Medicina Interdisciplinar em Cardiologia, InCor, Hospital das Clínicas HCFMUSP, Faculdade de Medicina da Universidade de São Paulo, Av. Dr Eneas de Carvalho Aguiar 44-Cerqueira Cesar, São Paulo, SP, Brazil. 2. Hospital Israelita Albert Einstein, São Paulo, Brazil. 3. Laboratorio de Carboidratos e Radioimunoinsaio, LIM 18, Hospital das Clinicas HCFMUSP, Faculdade de Medicina da Universidade de Sao Paulo, São Paulo, Brazil. 4. Programa de Pós-Graduação em Medicina, Universidade Nove de Julho (UNINOVE), São Paulo, Brazil. 5. Serviço de Onco-Endocrinologia, ICESP, HCFMUSP Universidade de Sao Paulo, Sao Paulo, Brazil. 6. Unidade de Medicina Interdisciplinar em Cardiologia, InCor, Hospital das Clínicas HCFMUSP, Faculdade de Medicina da Universidade de São Paulo, Av. Dr Eneas de Carvalho Aguiar 44-Cerqueira Cesar, São Paulo, SP, Brazil. bcaramel@usp.br.
Abstract
PURPOSE: To compare the effects of the sleeve gastrectomy with transit bipartition (SG + TB) procedure with standard medical therapy (SMT) in mildly obese patients with type II diabetes (T2D). METHODS: This is a prospective, randomized, controlled trial. Twenty male adults, ≤ 65 years old, with T2D, body mass index (BMI) > 28 kg/m2 and < 35 kg/m2, and HbA1c level > 8% were randomized to SG + TB or to SMT. Outcomes were the remission in the metabolic and cardiovascular risk variables up to 24 months. RESULTS: At 24 months, SG + TB group showed a significant decrease in HbaA1c values (9.3 ± 2.1 versus 5.5 ± 1.1%, P = < 0.05) whereas SMT group maintained similar levels from baseline (8.0 ± 1.5 versus 8.3 ± 1.1%, P = NS). BMI values were lower in the SG + TB group (25.3 ± 2.8 kg/m2 versus 30.9 ± 2.5 kg/m2; P = < 0.001). At 24 months, none patient in SG + TB group needed medications for hyperlipidemia/hypertension. HDL-cholesterol levels increased in the SG + TB group (33 ± 8 to 45 ± 15 mg/dL, P < 0.001). After 24 months, the area under the curve (AUC) of GLP1 increased and in the SG + TB group and the AUC of the GIP concentrations was lower in the SG + TB group than in the SMT. At 3 months, SG + TB group showed a marked increase in FGF19 levels (74.1 ± 45.8 to 237.3 ± 234 pg/mL; P = 0.001). CONCLUSIONS: SG + TB is superior to SMT and was associated with a better metabolic and cardiovascular profile.
RCT Entities:
PURPOSE: To compare the effects of the sleeve gastrectomy with transit bipartition (SG + TB) procedure with standard medical therapy (SMT) in mildly obesepatients with type II diabetes (T2D). METHODS: This is a prospective, randomized, controlled trial. Twenty male adults, ≤ 65 years old, with T2D, body mass index (BMI) > 28 kg/m2 and < 35 kg/m2, and HbA1c level > 8% were randomized to SG + TB or to SMT. Outcomes were the remission in the metabolic and cardiovascular risk variables up to 24 months. RESULTS: At 24 months, SG + TB group showed a significant decrease in HbaA1c values (9.3 ± 2.1 versus 5.5 ± 1.1%, P = < 0.05) whereas SMT group maintained similar levels from baseline (8.0 ± 1.5 versus 8.3 ± 1.1%, P = NS). BMI values were lower in the SG + TB group (25.3 ± 2.8 kg/m2 versus 30.9 ± 2.5 kg/m2; P = < 0.001). At 24 months, none patient in SG + TB group needed medications for hyperlipidemia/hypertension. HDL-cholesterol levels increased in the SG + TB group (33 ± 8 to 45 ± 15 mg/dL, P < 0.001). After 24 months, the area under the curve (AUC) of GLP1 increased and in the SG + TB group and the AUC of the GIP concentrations was lower in the SG + TB group than in the SMT. At 3 months, SG + TB group showed a marked increase in FGF19 levels (74.1 ± 45.8 to 237.3 ± 234 pg/mL; P = 0.001). CONCLUSIONS: SG + TB is superior to SMT and was associated with a better metabolic and cardiovascular profile.
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