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A Prospective Randomized Controlled Trial of the Metabolic Effects of Sleeve Gastrectomy with Transit Bipartition

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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.

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Funding

Fundação de Apoio à Pesquisa do Estado de São Paulo (FAPESP), Conselho Nacional de Desenvolvimento Científico e Tecnológico (CNPq).

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Authors and Affiliations

  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

    Fernanda R. Azevedo, Daniela Calderaro, Danielle M. Gualandro, Pai C. Yu & Bruno Caramelli

  2. Hospital Israelita Albert Einstein, São Paulo, Brazil

    Sergio Santoro

  3. Laboratorio de Carboidratos e Radioimunoinsaio, LIM 18, Hospital das Clinicas HCFMUSP, Faculdade de Medicina da Universidade de Sao Paulo, São Paulo, Brazil

    Maria L. Correa-Giannella

  4. Programa de Pós-Graduação em Medicina, Universidade Nove de Julho (UNINOVE), São Paulo, Brazil

    Maria L. Correa-Giannella & Daniel Giannella-Neto

  5. Serviço de Onco-Endocrinologia, ICESP, HCFMUSP Universidade de Sao Paulo, Sao Paulo, Brazil

    Marcos T. Toyoshima

Authors
  1. Fernanda R. Azevedo
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  2. Sergio Santoro
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  3. Maria L. Correa-Giannella
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  4. Marcos T. Toyoshima
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  5. Daniel Giannella-Neto
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  6. Daniela Calderaro
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  7. Danielle M. Gualandro
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  8. Pai C. Yu
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  9. Bruno Caramelli
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Corresponding author

Correspondence to Bruno Caramelli.

Ethics declarations

The study was approved by the Institutional Ethics Committee (CAPPesq 0355/11) and registered with ClinicalTrials.gov (NCT01581099).

Conflict of Interest

The authors declare that they have no conflict of interest.

Additional information

Daniel Giannella-Neto Deceased

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Azevedo, F.R., Santoro, S., Correa-Giannella, M.L. et al. A Prospective Randomized Controlled Trial of the Metabolic Effects of Sleeve Gastrectomy with Transit Bipartition. OBES SURG 28, 3012–3019 (2018). https://doi.org/10.1007/s11695-018-3239-3

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  • DOI: https://doi.org/10.1007/s11695-018-3239-3

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