Gastric bypass leads to more significant and
durable improvements in glycemic control than does sleeve gastrectomy or
intensive medical therapy in moderately obese patients with type 2
diabetes, a prospective, randomized controlled trial has found.
Two years after the procedure, patients randomized
to Roux-en-Y gastric bypass plus intensive medical therapy (IMT) had a
mean HbA1c of 6.7 ± 1.2%, compared with 7.1 ± 0.8% for those
who underwent sleeve gastrectomy and IMT, and 8.4 ± 2.3% for IMT alone,
reported Dr Sangeeta R. Kashyap of the Cleveland Clinic and colleagues.
While both surgical procedures resulted in similar
reductions in body weight, body mass index, and total body fat
percentage at 24 months, gastric bypass resulted in the greatest
absolute truncal fat reductions (–16% vs. –10%; P = .04), according to the findings, which were published online (Diabetes Care 2013 Feb. 25 [doi:10.2337/dc12-1596]).
The 2-year study enrolled a subset of 60 patients
from the 1-year STAMPEDE trial, which evaluated the efficacy and safety
of IMT alone – pharmacotherapy in conjunction with lifestyle
interventions – or IMT combined with gastric bypass or sleeve
gastrectomy. Of the 54 patients who completed the trial, the average age
was 48.4 years, with a mean BMI of 36 kg/m2; most patients were taking at least three different diabetes medications.
The study extension examined the effects of the
three treatment approaches on glucose control, pancreatic beta-cell
function including insulin secretion and sensitivity, and body
composition.
"Other long-term observational studies have
documented greater relapse rates for glycemic control after gastric
restrictive procedures such as sleeve gastrectomy, suggesting that
surgical weight loss from enforced caloric restriction itself is
insufficient to halt the disease," reported Dr Kashyap and colleagues.
"Our results extend the findings from our initial 12-month report and
suggest factors beyond weight loss that are specific to intestinal
bypass patients help regulate glucose levels and restore pancreatic
beta-cell function."
Gastric bypass was the only treatment to have any
significant effects on pancreatic beta-cell function, with a median
5.8-fold (quartile 1: –7.00; quartile Q3: 11.29) increase in beta-cell
function from baseline compared with only negligible increases for
sleeve gastrectomy and IMT.
Researchers also observed a 2.7-fold (N = 9, 3.8 vs. 1.4; P
< .001) increase in insulin sensitivity with gastric bypass among
subjects not using insulin, compared with a 1.2-fold (N=10; 5.8 vs. 5.3)
increase after sleeve gastrectomy, and no change in those randomized to
IMT (2.6 vs. 2.4; P = NS).
"Bariatric surgery, particularly gastric bypass
surgery, uniquely restores normal glucose tolerance and pancreatic
[beta]-cell function, presumably by targeting the truncal fat that
represents the core metabolic defect involved in diabetes pathogenesis,"
the researchers wrote.
Primary funding for the study came from Ethicon
Endo-Surgery, with ancillary funding from the American Diabetes
Association and the National Institutes of Health. The authors reported
receiving research grants, consultations and honoraria from various
companies and organizations, and one author received grants and
honoraria from Ethicon Endo-Surgery as scientific advisory board member,
consultant, and speaker.
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