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BOSTON -- Sleeve-ileal transposition surgery was associated with more weight loss and better outcomes than gastric bypass surgery and a lifestyle intervention among mildly obese patients with type 2 diabetes, according to a study presented here.
Researchers from Brazil took 42 patients and randomized them to sleeve-ileal transposition (sleeve-IT), gastric bypass surgery, or clinical intervention and found that at 12 months, body mass index (BMI) was lowest among sleeve-IT patients, who had a BMI of 22.9. Bypass patients had a 23.5 average, and those in the lifestyle group averaged 31.4 (P<0.001 for sleeve-IT versus clinical; P<0.001 for bypass versus clinical), according to Ana Priscila Soggia, MD, of Hospital Sírio-Libanes in São Paulo.
Action Points
- Note that this study was published as an abstract and presented at a conference. These data and conclusions should be considered to be preliminary until published in a peer-reviewed journal.
Also after 12 months, all patients who had sleeve-IT achieved an HbA1c under 6.5% compared with 46% of gastric bypass patients, and 8% of clinical intervention patients, they said in a presentation at the Endocrine Society annual meeting.
"This study showed that the sleeve-IT surgery has better results in glycemic control than the clinical and bypass treatment," Soggia said. "Although this study has a small number of patients, the results enable further protocols to evaluate this surgical technique for the treatment of diabetes."
The single-center center enrolled 42 patients, ages 18-65, with class I obesity (BMI 30-35 kg/m2) and poorly controlled diabetes (HbA1c greater than 7%). At baseline, the patients had an average BMI of 32.2 kg/m2 and HbA1c of 9.3%. The mean age was 53.
They were randomized to sleeve-IT, gastric bypass surgery, or clinical treatment, which consisted of intensive medical therapy including lifestyle counseling, weight management, frequent glucose monitoring, and the use of newer drug therapies.
All of the bypass surgeries used a laparoscopic approach to create a 15 to 20 ml gastric pouch, a 150 cm Roux limb, and a 50 cm biliopancreatic limb.
For the sleeve-IT procedure, surgeons created a gastric sleeve with a volume reduction of 75-80%, duodenal exclusion, and ileal transposition of 170 cm between the duodenum and jejunum.
Three months post-treatment, HbA1c levels averaged and 6.5% for the sleeve-IT group, 7.1% for the bypass patients, and 7.9% for the clinical group.
At 12 months, HbA1c levels averaged 5.5% for the sleeve-IT group, 6.9% for the bypass group, and 7.7% for the clinical group (P=0.01 for sleeve versus clinical; P=0.04 for sleeve versus bypass).
After 12 months, an HbA1c less than 6.5% was achieved by 100% of the sleeve-IT group, 46% of the bypass group, and 8% of the clinical group (P<0.001 for sleeve-IT versus clinical; P=0.002 for sleeve versus bypass).
Diabetes remission (glycemic control without medication) was achieved by 75% of of the sleeve-IT group and 30% of the bypass group (P=0.04 for sleeve versus bypass).
Cholesterol levels also changed at the 12-month mark. For LDL, the sleeve-IT group averaged 86 down from 110 at baseline, while the bypass group went from 105 at baseline to 73, and the clinical group averaged 94 down from 118 at baseline.
HDL levels also changed at 1 year (P<0.001 sleeve versus clinical; P=0.02 sleeve versus bypass):
- Sleeve-IT: average 62 up from 44 at baseline
- Bypass: average 55 up from 45 at baseline
- Clinical: average 42 down from 46 at baseline
Surgery time averaged 80 minutes for the bypass group and 135 minutes for the sleeve-IT group. There was one major postoperative complication in each group, but no deaths related to the procedures.
Chronic abdominal pain was reported by two patients in each of the surgical groups. Chronic diarrhea was reported by 41% in the sleeve-IT group and 23% patients in the bypass group. Hypokalemia occurred in 8% sleeve-IT group and 38% of bypass patients. Anemia occurred in 25% of sleeve-IT patients and 54% of bypass patients. B-12 deficiency was found in 58% of sleeve-IT patients and 46% of bypass. Iron deficiency occurred in 41% of sleeve-IT patients and 30% of bypass.
Soggia said her group will continue follow-up for 24 to 36 months.
Disclosures
The study was sponsored by the Hospital Sirio-Libanês, through its philanthropic program PROADI.
Soggia and co-authors disclosed no relevant relationships with industry.
Primary Source
The Endocrine Society
Soggia AP, et al "Bariatric bypass surgery versus sleeve with ileal transposition surgery versus clinical treatment in class I obesity patients with diabetes" ENDO 2016; Abstract OR12-5.