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STAMPEDE Trial: Surgery boosts patients’ long-term QoL compared with medical therapy alone

The latest analysis from the STAMPEDE (Surgical Therapy and Medications Potentially Eradicate Diabetes Efficiently) trial shows that over the course of five years, patients who had bariatric and metabolic surgery to treat uncontrolled type 2 diabetes reported greater physical health, more energy, less body pain, and less negative effects of diabetes in their daily lives, compared with patients who had medical therapy alone for their diabetes. Long-term changes in psychosocial and emotional quality of life measures were not significantly different between the surgical and medical groups. The research, ‘Patient Reported Outcomes after Metabolic Surgery Versus Medical Therapy for Diabetes’, was published in the Annals of Surgery.

"Chronic diseases, such as severe obesity and diabetes, can negatively affect quality of life," said Dr Ali Aminian, director of Cleveland Clinic's Bariatric & Metabolic Institute and lead author of the study. "It is important to study the effects of different treatments on the well-being of patients in their daily lives."

The Cleveland Clinic-led STAMPEDE study was the first randomised controlled clinical trial that compared head-to-head bariatric surgery with intensive medical therapy for the treatment of type 2 diabetes in patients with poorly controlled diabetes and obesity.

The trial initially involved 150 participants, who were divided into three groups: 1) Fifty patients received intensive medical therapy only, including counselling and medications; 2) Fifty patients underwent Roux-en-Y gastric bypass surgery and received medical therapy; 3) Fifty patients underwent sleeve gastrectomy and received medical therapy. Effectiveness was gauged by the percentage of patients who achieved blood sugar control, defined in this study as HbA1c level of less than or equal to 6.0 percent - a more aggressive target than the American Diabetes Association's guidelines.

The study's initial results showed that metabolic surgery is superior to medical therapy alone for achieving weight loss and diabetes control with less reliance on anti-diabetic medications. The five-year results showed that the benefits of metabolic surgery persist over time.

This current analysis looked at 104 STAMPEDE trial participants: 1) Twenty-six patients who received intensive medical therapy only; 2) Forty-one patients who underwent Roux-en-Y gastric bypass surgery and received medical therapy; 3) Thirty-seven patients who underwent sleeve gastrectomy and received medical therapy.

The 104 patients were asked to answer two generic health-related quality of life questionnaires (the RAND 36-Item Health Survey and European QoL 5-Dimensions) and a diabetes-specific questionnaire at the beginning of the trial, and then on an annual basis following enrolment. Those three questionnaires were chosen to assess how surgical or medical treatment of obesity and diabetes may affect key elements of quality of life.

The results show that over the course of five years, the 78 patients in the surgical groups had significantly better scores on physical functioning, more energy, less body pain, and improved general heath scores compared with the 26 patients in the medical therapy group. The diabetes questionnaire looked at 12 various aspects of life in patients who have type 2 diabetes, such as maintaining a diet, going on vacation, planning meals or eating out with others, and family life.

Over five years, data show that diabetes has less negative impact on quality of life in the metabolic surgery groups compared with the medical therapy group. The favourable changes following RYGB and SG were comparable. On multivariable analysis, independent factors associated with improved general health perception at long-term included baseline general health (p<0.001), insulin independence at five-years (p=0.005), RYGB versus IMT (p=0.005), and SG versus IMT (p=0.034).

"Patients with long duration of diabetes tend to have poor quality of life, especially when they develop microvascular complications like eye and kidney diseases," said Dr Sangeeta Kashyap, co-investigator involved with the trial and an endocrinologist at Cleveland Clinic's Endocrinology & Metabolism Institute. "When diabetes is coupled with obesity, the impact on lower quality of life can be related to the mechanical effects of obesity as well, which leads to poor mobility and bodily pain. Significant weight loss and insulin independence following metabolic surgery drive the improvement in general health measures and quality of life for patients with type 2 diabetes.”

"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."

More long-term research is needed to continue to gather feedback directly from patients on the effects of metabolic surgery on their quality of life.

The STAMPEDE trial was financially supported by Ethicon, with additional support from LifeScan, Cleveland Clinic, and the National Institutes of Health. The sponsors had no role in the accrual or analysis of the data or in the preparation of this manuscript.


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