In a group of moderately obese patients with type 2 diabetes, Roux-en-Y gastric bypass and laparoscopic adjustable gastric banding resulted in complete disease remission in 17% and 23%, respectively.
Partial remission was significantly more common among the Roux-en-Y patients, with 50% achieving it, compared with 27% of the gastric banding patients, Dr. Anita Courcoulas and her colleagues reported in the June 4 online issue of JAMA Surgery (JAMA Surg. 2014 [doi:10.1001/jamasurg.2014.467]). There were no partial or complete remissions in the study’s third arm – a year-long intensive lifestyle-management program.
Dr. Anita P. Courcoulas
The results are encouraging, but because the study had only 69 patients with just 1 year of follow-up, "no definitive conclusions can be drawn," about the durability of disease remission, Dr. Courcoulas, a bariatric surgeon at the University of Pittsburgh Medical Center, and her associates wrote.
"Nevertheless, the [lifestyle management arm] had no remission, so these results suggest that the gastric banding procedure – low risk and potentially reversible – may have a place as a treatment option for patients with low body mass index and type 2 diabetes. Further studies will be needed to confirm these results," the investigators wrote.
The patients were an average of 47 years old, with a mean body mass index (BMI) of 35 kg/m2. The mean duration of type 2 diabetes was 6 years. The average HbA1c was 8%. Almost all were taking some kind of antidiabetic medication; 40 were on oral drugs, and 26 were taking insulin.
By 1 year, there were no cases of partial or complete remission in the lifestyle intervention group. In the Roux-en-Y group, 50% experienced a partial remission and 17% a complete remission. In the gastric banding group, 27% experienced a partial remission and 23% a complete remission.
Patients in the Roux-en-Y group lost significantly more weight than those in the banding or lifestyle groups (27% vs. 17% and 10% respectively). HbA1c improved significantly more in the Roux-en-Y group than in the banding or lifestyle groups as well. Significantly more surgical patients than lifestyle patients were able to be off all antidiabetic medications (58% vs. 36% and 4%, respectively).
Surgical safety was good, with six patients needing one additional hospital night for nausea or glucose management. One banding patient needed a port replacement, and three others had minor clinical problems. There were three serious adverse events, including an anastomotic ulcer in one Roux-en-Y patient and dehydration requiring a hospital stay in two gastric banding patients.
The study also highlighted some of the problems with accruing and retaining patients in weight loss trials, the investigators noted. Of 667 screened patients, 69 (10%) were randomized. Of these, seven refused their assigned treatment, and one was excluded from treatment on the procedure day. Six had incomplete follow-up and five – all in the lifestyle intervention arm – withdrew by 6 months.
Because the planned 12-month follow-up was too short to allow any conclusions about the stability of diabetes remission in treated patients, longer follow-up is crucial and will require considerable financial investments.
"These important feasibility issues – the need for targeted screening, the thorough assessment of clinical equipoise to reduce the likelihood of postrandomization dropout, the challenging retention in the [lifestyle] arm, and funding – raise a number of concerns for the scalability of this type of study to a larger multicenter trial. For this reason, pursuing alternative methods to obtain high-order evidence regarding outcomes of surgical vs. nonsurgical treatment may be more reasonable for people with a relatively low BMI," they said.
The study was funded by the National Institutes of Health. Dr. Courcoulas disclosed financial relationships with Covidien, EndoGastric Solutions, Nutrisystem, and Ethicon J&J Healthcare. Some of the other authors disclosed financial relationships with a variety of pharmaceutical companies.