Bariatric Surgery in Type 2 Diabetes: Half in Complete or Partial Remission at 6 Years

April 26, 2013

VIENNA — A fourth of patients with type 2 diabetes who underwent bariatric surgery for obesity showed metabolic remissions at six years, another 25% had partial remissions, and both rates were higher among those getting Roux-en-Y gastric bypass, in the recent four-year "real-world" experience of a major US center[1]. Both weight-loss and metabolic results were consistently better after gastric bypass than after other types of bariatric surgery, with Roux-en-Y bypass achieving a 27% rate of "cure" as defined by an American Diabetes Association (ADA) consensus statement[2], according to a report here at the Prediabetes and the Metabolic Syndrome 2013 Congress .

Given that <20% of US type 2 diabetics achieve goals for HbA1c, blood pressure (BP), and LDL cholesterol, the experience suggests bariatric surgery "induces a significant and sustainable remission" in obese patients with diabetes "and should be considered early in the course of the disease," said Dr Philip Schauer (Cleveland Clinic, OH) in his presentation. Indeed, overall, the earlier in their disease patients underwent the surgery, the better their response.

To heartwire , Schauer said the analysis based on 217 patients getting the surgeries at his center over a recent four years showed "excellent long-term control" of metabolic risk factors, and he acknowledged obvious limitations in declaring a disease cured; the ADA defines cure as a complete remission lasting at least five years. "It's 'cure' in quotes, for sure." Terms for all of the treatment milestones used in the analysis were taken from the ADA consensus statement, he said.

Percent (%) With HbA1c-Defined Status (Unchanged, Improved, Partial Remission, Complete Remission, Recurrence) at Six years Median Follow-up

HbA1c status Total cohort, n=217 Roux-en-Y, n=162 Sleeve gastrectomy, n=23 Gastric banding, n=32
Unchanged 16 8 17 56
Partial remission 26 30 22 9
Complete remission 24 31 9 0
Improved 34 31 52 35
Recurrence 19 17 38 33

Partial remission=HbA1c 6%–6.4% and fasting blood glucose 100–125 mg/dL for one year off antidiabetic medications

Complete remission=HbA1c <6% and fasting blood glucose <100 mg/dL off antidiabetic medications

Improved=HbA1c reduction by >1%; or fasting blood glucose reduction by >25 mg/dL; or reduction of HbA1c and fasting blood glucose with discontinuation of either insulin or one oral antidiabetic or with a 50% reduction in medication dosage for at least one year

Recurrence=After a complete or partial remission, entering complete or partial remission and then having HbA1c >6.5%, fasting blood glucose >126 mg/dL, or need for antidiabetic medication

Both body-mass index (BMI) and HbA1c levels fell off to highly significant degrees over six years for the group getting Roux-en-Y bypass; BMI dropped significantly for patients who had undergone sleeve gastrectomy or gastric banding, but metabolic markers didn’t improve significantly in the gastric-banding group.

Six-Year Changes in HbA1c and BMI in 217 Patients, by Type of Bariatric Surgery

Parameter Roux-en-Y, n=162 Sleeve gastrectomy, n=23 Gastric banding, n=32
HbA 1c (%, absolute points) -1.4 -0.8 -0.2
p <0.001 0.049 0.64
BMI -13.3 -10.8 -5.7
p <0.001 <0.001 <0.001

The patients as a whole also showed significant average six-year improvements in fasting blood glucose (by a mean of 41.6 mg/dL), triglycerides (by 63.9 mg/dL), and in LDL cholesterol, HDL cholesterol, and systolic and diastolic blood pressure (p<0.001 for all improvements).

In a multivariate analysis that controlled for sex, age, BMI, HbA1c, fasting blood glucose, whether ADA-defined glycemic control was achieved, and insulin use, according to Schauer, significant predictors of metabolic remission included greater excess weight loss (p=0.006), shorter diabetes duration before surgery (p<0.001), and gastric bypass vs gastric banding (p=0.02). In an analysis of only those getting Roux-en-Y gastric bypass, independent predictors were lower excess weight loss (p=0.023), longer diabetes duration before surgery (p=0.031), and degree of weight gain from lowest weight measurement (p=0.015).

Metabolic and Other Changes Over Six Years, Bariatric-Surgery Cohort

Parameter Baseline 6 y
Meeting ADA biomarker goals    
HbA1c <7 (%) 43 80
BP <130/80 mm Hg (%) 17 62
LDL <100 mg/dL (%) 52 72
All 3 goals (%) 3 28
Oral antidiabetic medication use    
Number of agents (mean) 1.8 0.7
No medications (%) 5 54
Framingham 10-y CV risk score (mean) 28 21.6

p<0.001 for all differences between baseline and six years

After Schauer's presentation, Dr Lars Sj ö str ö m (Sahlgrenska Academy, University of Gothenburg, Sweden) rose to openly wonder about some tortuous terminology in the ADA definitions and whether some reparative changes are needed. He pointed out that an HbA1c of >6.5% defined diabetes but a complete remission isn't achieved until it declines to <6.0%.

"Why should we have a higher cutoff when patients develop a disease and a lower cutoff when they remit from the same disease?" asked Sjöström, who was the longtime principal investigator of the >3000 patient case-matched prospective Swedish Obese Subjects study, which helped establish bariatric surgery as a metabolic treatment, not just for weight loss.

"We don't do that for hypertension or lipid disturbances," he said. "As a scientist, I can see an advantage, but I also think it can create a lot of confusion in the healthcare system."

Schauer replied, "I agree there is a bit of confusion. For example, below 6.5%, a person no longer meets the definition of diabetes. But is that remission or something else? We know that HbA1c of 6.2%, for example, isn't normal. . . . So I agree there needs to be some work in terms of better defining remission." He asked Sjöström whether 6.5% would be a better cutoff for defining remission.

"Wouldn't it be clearer to talk about 'remission from diabetes' and 'remission from prediabetes?' " he said. (The HbA1c cutoffs for a diagnosis of prediabetes are >5.7% and <6.5%.)

And Schauer agreed.

Schauer discloses research support from Ethicon Endo-Surgery, the National Institutes of Health, Bard-Davol, Stryker Endoscopy, Gore, Baxter, Covidien, and Allergan and consulting for or receiving honoraria from Ethicon Endo-Surgery, RemedyMD, Bard-Davol, Stryker Endoscopy, Gore, Barosense, Covidien, Surgiquest, Carefusion, Orexigen, Vivus, and Apollo Endosurgery. Sjöström has previously disclosed receiving unrestricted grants from Sanofi and Johnson & Johnson; receiving lecture and consulting fees from AstraZeneca, Biovitrium, Bristol-Myers Squibb, GlaxoSmithKline, Johnson & Johnson, Lenimen, Merck, Novo Nordisk, Hoffman LaRoche, Sanofi, and Servier; and holding stocks in Lenimen and being chair of its board.

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