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T2DM criteria

ADA criteria results in lower rate of T2DM remission after surgery

Patients presenting complete remission were younger, with lower postoperative BMI and lower pre- and post-operative FPG and HbA1c levels

Using the more stringent American Diabetes Association (ADA) criteria for defining type 2 diabetes (T2DM) remission (ADA criteria) results in a lower rate of remission, compared to the criteria from several Spanish scientific associations Española de Endocrinología y Nutrición/Sociedad Española para el Estudio de la Obesidad/Sociedad Española de Diabetes(SEEN/SEEDO/SED), researchers from UGC Endocrinología y Nutrición, Hospital Reina Sofía, Córdoba, Spain. Their research paper, ‘Variations in diabetes remission rates after bariatric surgery in Spanish adults according to the use of different diagnostic criteria for diabetes’, was published in the journal BMC Endocrine Disorders.

How one defines remission of T2DM after bariatric surgery remains a contentious issue with some considering the withdrawal of medication to be the best criteria, while others believe using various fasting plasma glucose (FPG) and glycated haemoglobin (HbA1c) cut-off points or a combination of both, as the most accurate criteria.

In 2009, a consensus group from the ADA proposed a more stringent standard set of definition criteria based on biochemical (HbA1c and FPG levels) and clinical parameters (need for pharmacological treatment and duration of remission). In 2013, scientific associations in Spain published a position statement on metabolic surgery in patients with T2DM stating their set of criteria for define T2DM remission, which were similar to those approved by the ADA consensus group. Considering the difficulty in establishing remission of T2DM, Sánchez-Pernaute and Scopinaro have proposed using the ADA HbA1c cut-off point to diagnose T2DM.

As a result, the authors decided to compare T2DM remission rates five years after bariatric surgery using 2 different criteria: (1) those approved by Spanish scientific associations, based on HbA1c and FPG cut-off levels and need for diabetes medication, which classify their status as complete, prolonged or partial remission, improvement, or no remission; and (2) ADA criteria, based on HbA1c levels and need for diabetes medication, which classify patients’ status as complete or partial remission, optimal control, or no remission.

They subsequently conducted a retrospective study in 127 patients undergoing bariatric surgery in a single centre (Hospital Universitario Reina Sofía, Córdoba, Spain) between January 2001 and December 2009. All patients were diagnosed with T2DM and obesity before surgery, and had at least three years of follow-up with documentation of FPG, HbA1c levels, and body weight. Three types of bariatric surgery were performed: Roux-en-Y gastric bypass, sleeve gastrectomy and gastric band. The type of surgery was chosen depending on the patient’s preoperative characteristics.

Outcomes

A total of 127 patients (62.2% women) with T2DM were included in the study and the mean age at the time of surgery was 47±8 years; mean preoperative BMI was 50±7, FPG was 134±53 mg/dl and HbA1c was 8±7%.

Patients presenting complete remission were younger, with lower postoperative BMI and lower pre- and post-operative FPG and HbA1c levels. Patients with no remission using both reclassification systems were more likely to have been on insulin (Figure 1).

Figure 1: Remission rate in patients using or no using insulin. a Using Spanish reclassification; b Using ADA HbA1c reclassification

Roux-en-Y gastric bypass was performed in 96% of patients, sleeve gastrectomy in 3% and gastric band in the remaining 1%. Before surgery, 39 patients were in treatment with metformin, 6 with insulin and 13 with other oral diabetes medication (ODM). Nineteen (19) patients were in treatment with a combination of metformin and insulin, and 14 with metformin and other ODM. Of the remaining patients, 36 were following a dietary and exercise programme, as T2DM had been diagnosed less than 6 months before surgery.

After a mean follow-up of 5±2 years, mean BMI, FPG and HbA1c were 37±6, 100±28mg/dl and 6±1%, respectively. The difference between these and variables before and after surgery was statistically significant (paired samples t-tests; p=0.001, p=0.007 and p=0.003, respectively).

Following surgery, according to simplified HbA1c criteria, 52% achieved remission, 18.9% improvement and 29.1% no remission. According to Spanish criteria, 63.8% of patients presented with complete remission of T2DM (33.1% with prolonged remission), 8.7% achieved partial remission and 27.6% no remission (of which 21.3% showed improvement of T2DM). Statistically significant differences were observed between these reclassifications (McNemar’s test; p<0.001).

The reason behind this was that of 81 patients showing complete remission with the Spanish criteria, 59 achieved complete remission, 21 out of those 81 showed partial remission and 1 patient was classified as non-remitter according to ADA criteria. Thirty-five patients classified as non-remitters according to the Spanish reclassification were also considered non-remitters with the ADA criteria. Other 2 patients classified as non-remitters with ADA criteria were categorized in the group of complete remission (1) and partial remission (1) by Spanish reclassification. Fifty-nine (59) patients showed complete remission, 3 partial remission, and 35 no remission under both sets of criteria.

“In our 5-year follow-up study, we found that remission rates did differ depending on the definition criteria used. This is probably due to the fact that our follow-up period is one of the longest of all studies in T2DM remission,” they write. “This begs the question whether these remission rates can be sustained over a long-term follow-up of 10 years or more. ADA remission criteria are the most stringent and the most widely used. To confirm T2DM remission, therefore, these same criteria should be applied and updated according to established standards.”

“In conclusion, we believe that strict criteria based on those established by the ADA with the addition of the Spanish prolonged remission criteria should be used to determine true remission of diabetes following bariatric surgery,” the authors write. “Further studies in larger cohorts with longer follow-up periods are needed to conclusively show the best criteria for defining post-bariatric surgery diabetes remission.”

To access this paper, please click here

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