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Adjustable Gastric Banding and Conventional Therapy for Type 2 Diabetes - Adjustable Gastric Banding and Conventional Therapy for Type 2 Diabetes
Description:
The goal of this trial was to evaluate laparoscopic adjustable gastric banding compared with conventional approaches to weight loss and diabetes control in obese patients with recently diagnosed diabetes.
Hypothesis:
Laparoscopic adjustable gastric banding would result in a higher incidence of diabetes remission and reduction in glycated hemoglobin levels in obese patients, compared with conventional approaches to weight loss and diabetes control.
Study Design
- Randomized
Patients Screened: 158
Patients Enrolled: 60
NYHA Class: N/A
Mean Follow Up: 2 years
Mean Patient Age: 47 years
Female: 53
Mean Ejection Fraction: N/A
Patient Populations:
Age 20-60 years, BMI 30-40, diagnosis of type 2 diabetes within the previous 2 years, no renal insufficiency or diabetic retinopathy, and ability to provide study consent
Exclusions:
Type 1 diabetes or diabetes secondary to a specific disease, prior bariatric surgery, mental impairment, drug or alcohol addiction, recent major vascular event, or portal hypertension. Individuals were also excluded if they did not attend two prerandomization visits.
Primary Endpoints:
Proportion of patients with remission from diabetes. Remission was defined as fasting plasma glucose level <126 mg/dl and glycated hemoglobin value <6.2%.
Secondary Endpoints:
Percentage change in glycated hemoglobin level, weight, blood pressure, waist circumference, and fasting lipids; and change in medication use, proportion with metabolic syndrome, and indirect measures of insulin resistance
Drug/Procedures Used:
After a 3-month run-in period to optimize diabetes management by involvement of dieticians, general physicians, and endocrinologists, patients were randomized to laparoscopic adjustable gastric banding (n = 30) and conventional diabetes management (n = 30).
Concomitant Medications:
N/A
Principal Findings:
Baseline characterisics were well matched: body mass index (BMI) 37, weight 106 kg, weight circumference 115 cm, glycated hemoglobin level 7.7%, and total cholesterol 200 mg/dl. The primary outcome of remission from diabetes occurred in 73% of the laparoscopic banding group and 13% of the conventional therapy group (p < 0.001).
Similarly, for banding versus conventional therapy, weight was reduced 21.1 kg versus 1.5 kg (p < 0.001), waist circumference was reduced 17.9 cm versus 4.0 cm (p < 0.001), systolic blood pressure was reduced 6.0 mm Hg versus 1.7 mm Hg (p = 0.37), glycated hemoglobin level was reduced 1.81% versus 0.38% (p < 0.001), and total cholesterol to high-density lipoprotein (HDL) cholesterol ratio was reduced 0.82 versus 0.14 (p = 0.02).
In the banding group, there was one superficial infection treated with antibiotics, two episodes of gastric pouch enlargement that required gastric band replacement, and one episode of persistent regurgitation that required gastric band removal.
Interpretation:
Among obese patients with BMI between 30 and 40 and type 2 diabetes diagnosed within the preceding 2 years, laparoscopic adjustable gastric banding resulted in a significant increase in the proportion of patients with remission of diabetes. Gastric banding also resulted in significant reductions in weight, waist circumference, glycated hemoglobin level, and total cholesterol to HDL cholesterol ratio. Systolic blood pressure was also nonsignificantly reduced by gastric banding.
This is a remarkable trial that documents profound health benefits among obese patients and type 2 diabetes 2 years after laparoscopic gastric banding. This was achieved with minimal surgical risk.
It is unknown if these beneficial effects remain beyond 2 years. The fact that surgery was conducted at a highly specialized center makes extrapolation to the community setting difficult. Also, different surgical approaches for weight control were not compared against each other. This was not a placebo-controlled trial; however, this would have been very difficult to accomplish ethically since it would have required a sham procedure.
References:
Dixon JB, O'Brien PE, Playfair J, et al. Adjustable gastric banding and conventional therapy for type 2 diabetes: a randomized controlled trial. JAMA 2008;299:316-23.
Keywords: Weight Loss, Body Weight, Diabetes Mellitus, Type 2, Blood Pressure, Glycated Hemoglobin A, Metabolic Syndrome, Waist Circumference, Cholesterol, Renal Insufficiency, Diabetic Retinopathy, Body Mass Index, Obesity, Diet, Nutritionists, Hypertension
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