An analysis of a subset of patients from the STAMPEDE trial provides new evidence detailing the quality of life improvements associated with undergoing bariatric surgery in patients with uncontrolled type 2 diabetes.
Through comparison of long-term, patient-reported data between those who received medical management and those who underwent weight loss surgery, investigators found undergoing surgery was associated with quality of life improvements across multiple domains, including health perception, fatigue, and the effects of diabetes on the day-to-day lives of patients compared to their counterparts who did not undergo surgery.
“Chronic diseases, such as severe obesity and diabetes, can negatively affect quality of life,” said lead investigator Ali Aminian, MD, Director of Bariatric & Metabolic Institute at the Cleveland Clinic, in a press release. “It is important to study the effects of different treatments on the well-being of patients in their daily lives.”
With so many patients finding weight loss a difficult proposition and the evidence base supporting surgical interventions continuing to grow, the popularity of bariatric surgery has exploded in the past decade. Due to the relative recency of this popularity surge, data related to long-term outcomes can prove to be invaluable when guiding treatment decisions.
Comparing surgical therapy against intensive medical therapy or intensive medical therapy plus Roux-en-Y gastric bypass (RYGB) or sleeve gastrectomy, the Surgical Treatment And Medications Potentially Eradicate Diabetes Efficiently (STAMPEDE) trial followed patients for up to 5 years and had a primary endpoint of glycated hemoglobin level of 6.0% or less with or without use of antidiabetes medications. In total, 150 patients were included in the trial with 50 randomized to each arm.
For the current study, investigators sought to assess potential differences in responses to a pair of health-related quality of life questionnaires and a diabetes-specific questionnaire at baseline and every year after through completion of the trial. For their analysis, investigators identified a subset of 104 STAMPEDE participants with data from questionnaires for inclusion in their analyses. Of these 104, 26 received medical therapy only, 41 received RYGB, and 37 underwent sleeve gastrectomy.
Of note, the specific health-related quality of life questionnaires used in the trial were the Rand 36-item Health Survey and European QoL 5-Dimensions.
Upon analysis, results suggested undergoing RYGB and sleeve gastrectomy was associated with significant improvements in multiple domains, including physical functioning, general health perception, energy/fatigue, and diabetes-related quality of life compared to their counterparts in the intensive medical therapy arm of the study. Investigators also noted no patients in the medical therapy arm experienced significant improvements in any of the quality of life components within the generic questionnaires.
Investigators pointed out no significant long-term differences were noted among study groups in measures of psychological and social aspects of quality of life. In multivariable analysis, results suggested baseline general health (P <.001), insulin independence at 5-years (P=.005), RYGB versus IMT (P=.005), and SG versus IMT (P=.034) were independent factors associated with improved general health perception.
“Our findings suggest that psychological well‐being needs may require more attention in metabolic surgical patients,” added Aminian. “As part of our multidisciplinary approach to weight management at Cleveland Clinic, our patients have appointments with psychologists before and after surgery. The study results highlight that we may need greater emphasis on that aspect of the treatment, such as identification of psychosocial and emotional factors before surgery that can predict outcomes of surgery, as well as continuous psychosocial support after surgery.”
This study, “Patient Reported Outcomes after Metabolic Surgery Versus Medical Therapy for Diabetes: Insights from the STAMPEDE Randomized Trial,” was published in the Annals of Surgery.