In Patients with Uncontrolled T2D, Bariatric Surgery Associated with Long-term Improvement in Physical Domains, Diabetes-related QoL

Five years after bariatric surgery for uncontrolled T2D patients reported improvements in physical health and QoL but measures of psychosocial wellbeing remained flat.

Metabolic surgery in patients with uncontrolled type 2 diabetes (T2D) is associated with greater physical health and energy level and reduced negative disease impact on daily life compared to medical therapy alone, but a new analysis of data from the Cleveland Clinic-led STAMPEDE study suggests that while physical domains of health benefit from surgical weight loss, emotional components may require greater clinical focus.

Over the 5-year course of STAMPEDE (Surgical Therapy and Medications Potentially Eradicate Diabetes Efficiently), study authors found no significant long-term differences between surgical and medical groups in measures of psychosocial and emotional quality of life. They published their findings in the Annals of 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.”

The original STAMPEDE trial, (NEJM, 2012) compared the efficacy for glycemic control of intensive medical therapy (IMT) alone vs IMT plus Roux-en-Y gastric bypass (RYGB) or sleeve gastrectomy (SG) in 150 obese patients with uncontrolled T2D (mean age 49 years, 66% women, mean baseline A1c 9.2%). Patients were randomized 50 to each arm and the primary endpoint was the proportion of participants with A1c ≤6%, with or without antihyperglycemic medication, at 12 months after randomization.

Metabolic surgery was superior to IMT alone for weight loss and control of A1c and results were durable at 5-year follow-up.

The current analysis of STAMPEDE focused on the long-term impact of the medical and surgical treatments on patient-reported quality of life (QoL) measures. Investigators evaluated data collected from a subset of 104 participants who were administered the RAND 36-Item Health Survey (RAND-36) and European QoL 5-Dimensions (EQ-5D-3L) generic QoL questionnaires and a diabetes-specific questionnaire at baseline and annually for 5 years after randomization. Of the 104 participants, 26 had IMT only; 41 underwent RYGB, and 37 underwent SG.

Aminian et al found that over the 5 years of follow-up, the 78 patients in the 2 surgical groups scored significantly higher on measures of physical functioning, general health perception, and energy/fatigue compared to those in the IMT arm. Measures of diabetes-related quality of life also showed greater improvement in the surgical vs IMT groups.

Among the 26 patients in the IMT group there was no significant improvement observed from baseline in any of the QoL components included in RAND-36 and EQ-5D-3L questionnaires.

When investigators compared all 3 groups, they found no significant long-term differences in measures of psychological and social aspects of QoL. Multivariable analysis identified 4 independent factors associated with improved general health perception:

  • Baseline general health (P<.001)
  • Insulin independence at 5 years (P=.005)
  • RYGB versus IMT (P=.005)
  • SG versus IMT (P=.034)

“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.”