In a randomized, controlled study of obese patients with type 2 diabetes, those who received medical therapy plus bariatric surgery had significantly better glycemic control at 12 months than did those who received medical therapy alone.
The growing incidence of obesity and type 2 diabetes mellitus globally is widely recognized as one of the most challenging contemporary threats to public health. Uncontrolled diabetes leads to macrovascular and microvascular complications, including myocardial infarction, stroke, blindness, neuropathy, and renal failure in many patients. Despite improvements in pharmacotherapy, fewer than 50% of patients with moderate-to-severe type 2 diabetes actually achieve and maintain therapeutic thresholds, particularly for glycemic control.
• What was the goal of intensive medical therapy in this study?
The goal of medical management was modification of diabetes medications until the patient reached the therapeutic goal of a glycated hemoglobin level of 6.0% or less or became intolerant to the medical treatment. All patients were treated with lipid-lowering and antihypertensive medications, according to American Diabetes Association guidelines, with the following targets: systolic blood pressure, 130 mm Hg or less; diastolic blood pressure, 80 mm Hg or less; and low-density lipoprotein cholesterol, 100 mg per deciliter (2.6 mmol per liter) or less.
• What were the primary results of this study, which compared intensive medical therapy to surgical therapy to achieve control of diabetes?
At 12 months, mean levels of glycated hemoglobin and fasting plasma glucose were significantly lower in the two surgical groups (gastric bypass and sleeve gastrectomy) than in the medical-therapy group (P<0.001 for both comparisons).
Morning Report Questions
Q: What differences were noted between the two surgical groups?
A: The target glycated hemoglobin level of 6.0% or less at 12 months occurred in 21 of 50 patients (42%) in the gastric- bypass group (P=0.002) and 18 of 49 patients (37%) in the sleeve-gastrectomy group (P=0.008). There were no significant differences in the primary end point between the two surgical groups (P=0.59). However, all patients in the gastric-bypass group who achieved the target glycated hemoglobin level did so without medications, whereas 5 of 18 patients (28%) in the sleeve-gastrectomy group required the use of one or more glucose-lowering drugs.
Q: How did adverse events compare between the three groups?
A: Additional surgical interventions were required in four patients, including laparoscopic procedures for blood-clot evacuation, assessment of nausea and vomiting, and cholecystectomy after gastric bypass and jejunostomy for feeding access to treat a gastric leak after sleeve gastrectomy. There were no deaths, episodes of serious hypoglycemia requiring intervention, malnutrition, or excessive weight loss among the three groups. Adverse events requiring hospitalization occurred in 11 (22%) of the gastric bypass patients, 4 (8%) of the sleeve-gastrectomy patients and 4 (8%) of the intensive medical-therapy group.