Effects of Duodenal-Jejunal Bypass Liner (EndoBarrier®) on Gastric Emptying in Obese and Type 2 Diabetic Patients.

INTRODUCTION: The duodenal-jejunal bypass liner (DJBL) is a promising technique for treating obesity and type 2 diabetes mellitus (T2DM). However, despite promising results, its mechanism of action has not been elucidated. It is thought to promote changes in gastric emptying owing to the neuro-endocrine axis. OBJECTIVE: The aim of this paper was to study DJBL-induced changes in gastric emptying and the relationship of those changes with weight loss and T2DM. METHODS: Twenty-five patients with obesity and T2DM met inclusion criteria. Scintigraphic gastric emptying testing was performed prior to implantation, 16 weeks after implantation, and 4 weeks after removal. The average gastric retention was compared between tests, to examine the relationship between gastric emptying and those who lost more than 10 % of total body weight. Similarly, we compared average gastric retention between those who achieved a glycated hemoglobin target lower than 7 %. RESULTS: Average gastric retention was greater after DJBL implantation compared with the baseline (first hour, 74 ± 16.3 %, p = 0.001; second hour, 45 ± 25 %, p < 0.001; fourth hour, 15.8 ± 15 %, p < 0.001). There was no difference between the baseline and 4 weeks after device removal (fourth hour, p = 0.057). Gastric retention was similar between patients who achieved T2DM control and those who did not (p = 0.73). Additionally, no difference was seen between patients who lost more than 10 % of body weight and those who did not (p = 0.275). CONCLUSIONS: DJBL delays gastric emptying but is reversible after withdrawal. The changes in gastric emptying have no relationship to weight loss and T2DM control.

Efeitos do dispositivo temporário de exclusão duodenojejunal sobre o esvaziamento gástrico de pacientes obesos e diabéticos tipo 2 / Effects of temporary duodenojejunal exclusion device on Gastric Emptying of obese and type 2 diabetic patients

INTRODUÇÃO: Obesidade é, hoje, considerada uma pandemia, com cerca de 500 milhões de obesos no mundo, com cerca de 2,8 milhões de mortes por ano. A cirurgia de bypass gástrico é um importante tratamento para obesidade, porém, não é isenta de riscos. O dispositivo temporário de exclusão duodeno jejunal - DTED (EndoBarrier Gastrointestinal Liner® GIDynamics, Inc. Lexington, MA), apresenta-se como uma nova forma de tratamento endoscópico da obesidade. Apesar dos bons resultados, os mecanismos de ação do DTED ainda não foram estudados, podendo as alterações humorais e do esvaziamento gástrico promovidas, ser os principais responsáveis pelos resultados obtidos. OBJETIVO: Estudar as alterações promovidas pelo DTED no esvaziamento gástrico, e a relação destas alterações com os resultados clínicos de perda de peso e controle do diabetes tipo 2. MÉTODOS: Vinte e cinco obesos e com diabetes tipo 2, que fizeram uso do DTED por período mínimo de 16 semanas e máximo de 24 semanas, realizaram teste de esvaziamento gástrico cintilográfico, antes, durante a 16ª semana de uso e após 4 semanas de retirada do DTED. Foram obtidas medidas de peso e hemoglobina glicada. As médias e desvio-padrão de retenção gástricas foram obtidas e comparadas entre os três exames realizados, e, após, comparados entre os pacientes que obtiveram e os que não obtiveram melhora no parâmetro clínico selecionado (perda de peso maior que 10%, e hemoglobina glicada menor que 7%). Também se avaliou subjetivamente a sensação de saciedade e quantidade de alimento ingerido durante a 16ª semana de uso do dispositivo. RESULTADOS: Quando avaliadas médias de retenção, nota-se que, na 16ª semana de uso, há maior retenção para a primeira, segunda e quarta horas quando comparados ao baseline (1ª h 74 ± 16,3 % p=0,001, 2ª h 45 ± 25% p < 0,001; 4ª 15 ± 15,8% p < 0,001). Não há diferença estatística entre as retenções na 16ª semanas entre os pacientes que atingiram e os que não atingiram...

INTRODUCTION: Obesity is now considered a pandemic, with about 500 million obese worldwide, with about 2.8 million deaths per year. The gastric bypass surgery is an important treatment for obesity, however, not without risks. The temporary duodenal jejunal exclusion device - DTED (EndoBarrier ® Gastrointestinal Liner GIDynamics, Inc. Lexington, MA), presents itself as a new form of endoscopic treatment of obesity. Despite the good results, the mechanisms of action of DTED have not been studied, and the humoral changes and changes in gastric emptying promoted by the device maybe are the main mechanisms of action of the device. OBJECTIVE: To study the changes introduced by DTED in gastric emptying, and the relationship of these changes with clinical outcomes of weight loss and control of type 2 diabetes. METHODS: Twenty five obese patients with type 2 diabetes who used the DTED for a minimum of 16 weeks and maximum 24 weeks underwent a scintigraphic gastric emptying test, before, during the 16th week of treatment and after 4 weeks of withdrawal the DTED. Measurements of weight, glycated hemoglobin were obtained. The mean and standard deviation of gastric retention were obtained and compared between the three tests, and after, compared between patients who were and those who showed no improvement in selected clinical parameters (weight loss greater than 10%, and lower glycated hemoglobin 7%). Also, a subjective evaluation of the feeling of satiety and amount of food ingested during the 16 weeks of device use was done. RESULTS: When evaluated average retention , we note that in the 16th week of use there is greater retention for the first, second and fourth hour compared to baseline (1st h 74 ± 16.3 % p = 0.001, 2nd h 45 ± 25 % p < 0.001 4th 15.8 ± 15 %, p < 0.001). There is no statistical difference among patients who achieved and those who have not reached the control of diabetes (p = 0.73) or among those who lost more than 10 % by weight and not lost...

Improvement of insulin resistance and reduction of cardiovascular risk among obese patients with type 2 diabetes with the duodenojejunal bypass liner.

BACKGROUND: This study aims to evaluate the effectiveness of the duodenojejunal bypass liner (DJBL) in the improvement of insulin resistance and reduction of cardiovascular risk among morbidly obese patients with type 2 diabetes mellitus, using the triglyceride/high-density lipoprotein (HDL) cholesterol ratio, percentage of weight loss, and glycemic control. METHODS: We used the TG/HDL ratio with a cutoff value of 3.5 to identify patients with insulin resistance. The value of the initial ratio was compared with the ratio obtained 6 months after implantation to evaluate whether an improvement in insulin resistance occurred. We also evaluated the improvement of glycated hemoglobin levels and the weight loss resulted from the use of the device and correlated that with the improvement of the TG/HDL ratio. RESULTS: All patients implanted with the device presented a statistically significant reduction of the HbA1c levels, with most patients (70.3%) obtaining diabetes control with HbA1c levels lower than 7% at the end of the study. All patients also presented a significant weight reduction, with an average loss of 12.6% of their initial weight. We observed an important improvement in insulin resistance and metabolic syndrome, with a significant reduction of the TG/HDL ratio from 5.75 to 4.36 (p < 0.001) and 42.6% of the patients presenting a TG/HDL ratio lower than 3.5 at the end of the study. CONCLUSIONS: The DJBL, when used for a period of 6 months, is effective in the control of diabetes, weight loss, improvement of insulin resistance, and decrease of cardiovascular risk among morbidly obese patients with type 2 diabetes mellitus.