BOSTON – An endoscopic procedure that heats and ablates a few centimeters of the surface of the duodenum reduced hepatic transaminases in patients with type 2 diabetes. According to an abstract released in advance of the annual meeting of the American Association for the Study of Liver Diseases , a reduction in transaminases was also seen in a subset of patients who had ultrasonographic evidence of hepatic steatosis.
The meeting presentation will focus on the results of two studies of patients with type 2 diabetes who received duodenal mucosal resurfacing (DMR) to about 9 circumferential cm of their duodenum. The first study, which was a single-site study of 30 patients, was the first human study of DMR. The second study was a multicenter study of 22 patients.
“A single duodenal mucosal resurfacing procedure resulted in a decrease of liver transaminases sustained for 12 months,” Annieke van Baar, an MD-PhD candidate in gastroenterology and hepatology at the Academic University Center, Amsterdam, wrote in the study abstract.
At 6 months after the one-time procedure, the composite cohort of patients in both studies saw a 25% reduction in alanine transaminase, with an absolute reduction of a mean 9.9 plus or minus 22.3 IU/mL. Mean aspartate transaminase also decreased by a mean of 21%, with absolute reduction of a mean 6.1 plus or minus 14.8 IU/mL.
For the subset of 23 patients in the composite cohort who had ultrasound-identified steatosis, AST decreased by 14.4 plus or minus 23 IU/mL at 6 months post procedure; the reduction from baseline was 7.6 plus or minus 9.8 IU/mL at 9 months.
Duodenal mucosal resurfacing, performed endoscopically as a day procedure, has been shown to improve metabolic markers for type 2 diabetes. Though the exact mechanism for improvement is not known, reduction in incretin and other hormonal signaling from the duodenum is thought to increase insulin sensitization.
Patient characteristics were similar in both studies, with a mean age of 52.8 years in the first study and 56.8 in the second. Mean body mass index was 32 kg/m2 in both studies. In the first study, mean baseline hemoglobin A1c (HbA1c) was 9.7%; HbA1c was 8.4% in the second study.
Both study groups saw significant reductions in HbA1c at 6 months post DMR, with reductions of 1.2 plus or minus 1.8% and 0.8 plus or minus 0.9% (P less than .001). Homeostatic model assessment of insulin resistance (HOMA-IR) was reduced after DMR as well, with reductions of 0.9 plus or minus 4, and 2.4 plus or minus 6.8 in the two study groups, though the decrease was not statistically significant.
The transaminase reductions and improved glycemic markers were not accompanied by significant weight loss: Patients lost a mean 1.8 plus or minus 3.6 kg in the first study, and 2.4 plus or minus 3.8 kg in the second study.
“This unique endoscopic intervention deserves further study to ascertain its potential efficacy as a treatment for fatty liver disease,” wrote Ms. van Baar and her coauthors.
The studies were funded by Fractyl Laboratories, the manufacturer of the DMR device. Ms. van Baar had no financial disclosures, but two coauthors reported relationships with Fractyl Laboratories, and another author disclosed relationships with multiple other pharmaceutical companies.
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