Cargando…

Gastric bypass versus best medical treatment for diabetic kidney disease: 5 years follow up of a single-centre open label randomised controlled trial

BACKGROUND: We compared the albuminuria-lowering effects of Roux-en-Y gastric bypass (RYGB) to best medical treatment in patients with diabetic kidney disease and obesity to determine which treatment is better. METHODS: A 5 year, open-label, single-centre, randomised trial studied patients with diab...

Descripción completa

Detalles Bibliográficos
Autores principales: Cohen, Ricardo V., Pereira, Tiago Veiga, Aboud, Cristina Mamédio, Zanata Petry, Tarissa Beatrice, Lopes Correa, José Luis, Schiavon, Carlos Aurélio, Pompílio, Carlos Eduardo, Quirino Pechy, Fernando Nogueira, Calmon da Costa Silva, Ana Carolina, Cunha da Silveira, Lívia Porto, Paulo de Paris Caravatto, Pedro, Halpern, Helio, de Lima Jacy Monteiro, Frederico, da Costa Martins, Bruno, Kuga, Rogerio, Sarian Palumbo, Thais Mantovani, Friedman, Allon N., le Roux, Carel W.
Formato: Online Artículo Texto
Lenguaje:English
Publicado: Elsevier 2022
Materias:
Acceso en línea:https://www.ncbi.nlm.nih.gov/pmc/articles/PMC9716325/
https://www.ncbi.nlm.nih.gov/pubmed/36467457
http://dx.doi.org/10.1016/j.eclinm.2022.101725
Descripción
Sumario:BACKGROUND: We compared the albuminuria-lowering effects of Roux-en-Y gastric bypass (RYGB) to best medical treatment in patients with diabetic kidney disease and obesity to determine which treatment is better. METHODS: A 5 year, open-label, single-centre, randomised trial studied patients with diabetic kidney disease and class I obesity after 1:1 randomization to best medical treatment (n = 49) or RYGB (n = 51). The primary outcome was the proportion of patients achieving remission of microalbuminuria after 5 years. Secondary outcomes included improvements in diabetic kidney disease, glycemic control, quality of life, and safety. For efficacy outcomes, we performed an intention-to-treat (ITT) analysis. This study was registered with ClinicalTrials.gov, NCT01821508. FINDINGS: 88% of patients (44 per arm) completed 5-year follow-up. Remission of albuminuria occurred in 59.6% (95% CI = 45.5–73.8) after best medical treatment and 69.7% (95% CI = 59.6–79.8) after RYGB (risk difference: 10%, 95% CI, −7 to 27, P = 0.25). Patients after RYGB were twice as likely to achieve an HbA1c ≤ 6.5% (60.2% versus 25.4%, risk difference, 34.9%; 95% CI = 15.8–53.9, P < 0.001). Quality of life after five years measured by the 36-Item Short Form Survey questionnaire (standardized to a 0-to-100 scale) was higher in the RYGB group than in the best medical treatment group for several domains. The mean differences were 13.5 (95% CI, 5.5–21.6, P = 0.001) for general health, 19.7 (95% CI, 9.1–30.3, P < 0.001) for pain, 6.1 (95% CI, −4.8 to 17.0, P = 0.27) for social functioning, 8.3 (95% CI, 0.23 to 16.3, P = 0.04) for emotional well-being, 12.2 (95% CI, 3.9–20.4, P = 0.004) for vitality, 16.8 (95% CI, −0.75 to 34.4, P = 0.06) for mental health, 21.8 (95% CI, 4.8–38.7, P = 0.01) for physical health and 11.1 (95% CI, 2.24–19.9, P = 0.01) for physical functioning. Serious adverse events were experienced in 7/46 (15.2%) after best medical treatment and 11/46 patients (24%) after RYGB (P = 0.80). INTERPRETATION: Albuminuria remission was not statistically different between best medical treatment and RYGB after 5 years in participants with diabetic kidney disease and class 1 obesity, with 6–7 in ten patients achieving remission of microalbuminuria (uACR <30 mg/g) in both groups. RYGB was superior in improving glycemia, diastolic blood pressure, lipids, body weight, and quality of life. FUNDING: The study was supported by research grants from Johnson & Johnson Brasil, Oswaldo Cruz German Hospital, and by grant 12/YI/B2480 from Science Foundation Ireland (Dr le Roux) and grant 2015-02733 from the Swedish Medical Research Council (Dr le Roux). Dr Pereira was funded by the Chevening Scholarship Programme (Foreign and Commonwealth Office, UK).