The Roux-en-Y gastric bypass is effective in achieving established diabetes treatment targets, but durability is unknown.
Dr Sayeed Ikramuddin and colleagues compared durability of Roux-en-Y gastric bypass added to intensive lifestyle and medical management in achieving diabetes control targets.
Observational follow-up of a randomized clinical trial at 4 sites in the United States and Taiwan, involving 120 participants who had a hemoglobin A1c (HbA1c) level of 8% or higher and a body mass index between 30.0 and 39.9 were followed up for 5 years, ending in 2016.
Lifestyle-intensive medical management intervention based on the Diabetes Prevention Program and LookAHEAD trials for 2 years, with and without Roux-en-Y gastric bypass surgery followed by observation to year 5.
|23% of participants in the gastric bypass group|
|Journal of the American Medical Association|
The American Diabetes Association composite triple end point of hemoglobin A1c less than 7%, low-density lipoprotein cholesterol less than 100 mg/dL, and systolic blood pressure less than 130 mm Hg at 5 years.
The research team reported that of 120 participants who were initially randomized, 82% completed 5 years of follow-up.
The research team observed baseline characteristics were similar between groups, with a mean body mass index 34.4 for the lifestyle–medical management group and 34.9 for the gastric bypass group and had hemoglobin A1c levels of 9.6% and 9.6%, respectively.
At 5 years, the team found that 23% of participants in the gastric bypass group, and 4% in the lifestyle-intensive medical management group had achieved the composite triple end point.
In the fifth year, the researchers noted that 55% of patients in the gastric bypass group vs 14% in the lifestyle–medical management group achieved an HbA1c level of less than 7%.
The researchers reported that gastric bypass had more serious adverse events than did the lifestyle–medical management intervention, 66 events vs 38 events, most frequently gastrointestinal events and surgical complications such as strictures, small bowel obstructions, and leaks.
Gastric bypass had more parathyroid hormone elevation but no difference in B12 deficiency.
Dr Ikramuddin's team concludes, "In extended follow-up of obese adults with type 2 diabetes randomized to adding gastric bypass compared with lifestyle and intensive medical management alone, there remained a significantly better composite triple end point in the surgical group at 5 years."
"However, because the effect size diminished over 5 years, further follow-up is needed to understand the durability of the improvement."