A new analysis from the STAMPEDE study shows that patients who have had bariatric and metabolic surgery to treat uncontrolled type 2 diabetes have better physical health, more energy, less body pain, and fewer negative effects of diabetes in their lives Everyday life reported compared to patients who were medicated alone for their diabetes.
Long-term changes in psychosocial and emotional quality of life measures did not differ significantly between the surgical and medical groups. The research was published in the Annals of Surgery.
“Chronic diseases like severe obesity and diabetes can negatively impact quality of life,” said Ali Aminian, MD, director of the Bariatric & Metabolic Institute at the Cleveland Clinic and lead author on 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 (Surgical Therapy and Medications Potentially Eradicate Diabetes Efficiently) study was the first randomized controlled clinical trial to include bariatric head-to-head surgery with intensive care therapy for the treatment of type 2 diabetes in patients Compared to poorly controlled diabetes. and obesity.
The study initially enrolled 150 participants who were divided into three groups: 1) 50 patients received only intensive medical therapy, including counseling and medication; 2) 50 patients underwent Roux-en-Y gastric bypass surgery and received drug therapy; 3) 50 patients underwent gastric sleeve resection and received drug therapy. Efficacy was measured by the percentage of patients who achieved glycemic control, defined in this study as an HbA1c level of less than or equal to 6.0 percent – a more aggressive target than American Diabetes Association guidelines. HbA1c is a standard laboratory test that shows the average blood sugar over three months.
The initial results of the study indicated that metabolic surgery is superior to medical therapy alone for achieving weight loss and diabetes control with less dependence on antidiabetic drugs. The five-year results showed that the benefits of metabolic surgery persist over time.
In this current study, 104 participants of the STAMPEDE study were examined: 1) 26 patients who only received intensive care therapy; 2) 41 patients who underwent Roux-en-Y gastric bypass surgery and received medical therapy; 3) 37 patients who underwent sleeve gastrectomy and were treated with medication.
The 104 patients were asked to answer two generic questionnaires on health-related quality of life (the RAND 36-Item Health Survey and European QoL 5-Dimensions) and one diabetes-specific questionnaire at the beginning of the study and then annually after registration. These three questionnaires were selected to assess how surgical or medical treatment for obesity and diabetes can affect key elements of quality of life.
The results show that over the course of five years, the 78 patients in the operation groups had significantly better scores for physical function, more energy, less body pain and improved general health scores compared to the 26 patients in the drug therapy group. The diabetes questionnaire examined 12 different aspects of life of patients with type 2 diabetes, such as: These include dieting, going on vacation, planning meals or eating with others, and family life. Over five years, data show that diabetes has a less negative impact on quality of life in the metabolic-surgical groups than in the drug therapy group.
“Patients with long-term diabetes typically have poor quality of life, especially if they develop microvascular complications such as eye and kidney disease,” said Sangeeta Kashyap, MD, study co-researcher and endocrinologist at the Cleveland Clinic Institute’s Endocrinology & Metabolism. “If diabetes is linked to obesity, the impact on lower quality of life may also be linked to the mechanical effects of obesity, which lead to reduced mobility and physical pain. Significant weight loss and insulin independence after metabolic surgery generally drive improvements in health measures and quality of life for patients with type 2 diabetes, “said Dr. Kashyap.
“Our results suggest that the needs for psychological wellbeing in metabolic surgical patients may require more attention,” said Dr. Aminian. “As part of our multidisciplinary approach to weight loss at the Cleveland Clinic, our patients have pre- and post-surgery appointments with psychologists. The study results show that we may need to put more emphasis on this aspect of treatment, such as identifying psychosocial and emotional factors, “before surgery that can predict the outcome of the surgery, as well as ongoing psychosocial support after surgery.”
More long-term research is needed to continue to receive direct feedback from patients on the effects of metabolic surgery on their quality of life.
The STAMPEDE study was funded by Ethicon, with additional support from LifeScan, the Cleveland Clinic, and the National Institutes of Health. The sponsors played no role in the collection or analysis of the data, or in the preparation of this manuscript.
Source of the story:
Materials provided by Cleveland Clinic. Note: The content can be edited in terms of style and length.