Generalizability of Randomized Clinical Trial Outcomes for Diabetes Control Resulting From Bariatric Surgery
Edward H. Livingston, Hila Zelicha, Erik P. Dutson, Zhaoping Li, Matthew L. Maciejewski, Yijun Chen- Pharmacology (medical)
- Complementary and alternative medicine
- Pharmaceutical Science
Objective:
To assess the external validity of randomized controlled trials (RCTs) of bariatric surgical treatment on diabetes control.
Background:
Multisite RCTs provide the strongest evidence supporting clinical treatments and have the greatest internal validity. However, characteristics of trial participants may not be representative of patients receiving treatment in the real world. There is a need to assess how the results of RCTs generalize to all contemporary patient populations undergoing treatments.
Methods:
All patients undergoing sleeve gastrectomy at University of California Los Angeles (UCLA) between January 8, 2018 and May 19, 2023 had their baseline characteristics, weight change, and diabetes control compared with those enrolled in the surgical treatment and medications potentially eradicate diabetes efficiently (STAMPEDE) and diabetes surgery study (DSS) RCTs of bariatric surgery’s effect on diabetes control. Weight loss and diabetes control were compared between UCLA patients who did and did not fit the entry criteria for these RCTs.
Results:
Only 65 (17%) of 387 patients with diabetes fulfilled the eligibility criteria for STAMPEDE, and 29 (7.5%) fulfilled the criteria for DSS due to being older, having higher body mass index, and lower HbA1c. UCLA patients experienced slightly less weight loss than patients in the RCTs but had similar diabetes control. The 313 (81%) patients not eligible for study entry into either RCT had similar long-term diabetes control as those who were eligible for the RCTs.
Conclusions:
Even though only a very small proportion of patients undergoing bariatric surgery met the eligibility criteria for the 2 major RCTs, most patients in this contemporary cohort had similar outcomes. Diabetes outcomes from STAMPEDE and DSS generalize to most patients undergoing bariatric surgery for diabetes control.