Duodenum resurfacing procedure improved type 2 diabetes markers

An endoscopic procedure that alters the inner surface of the duodenum offered sustained HbA1c improvements for patients with type 2 diabetes, according to a presentation at the 19th World Congress of International Federation for the Surgery of Obesity & Metabolic Disorders in Montreal.

Developed by Fractyl Labs, the noninvasive Revita Duodenal Mucosal Resurfacing (DMR) procedure is designed to change how the body absorbs and processes glucose and could delay the need for insulin therapy and help patients who have not responded to oral medications, researchers said.

“Currently, doctors and patients struggle to keep diabetes and blood sugar levels under control, even with insulin therapy and numerous medicines available,” Manoel Galvao Neto, MD, a bariatric surgeon in Sao Paulo, told Endocrine Today. “We believe that diabetes is a digestive disease that can be treated procedurally without being the life-long burden that it is for most of the 400 million patients with the disease today.”

Manoel Galvao Neto

Neto and colleagues recruited 30 patients (22 male; mean age, 53.7 ± 8.2 years; mean BMI, 31.3 ± 3.5) with uncontrolled diabetes (mean HbA1c, 9.2%; mean diabetes duration, 5.7 ± 3 years) to receive DMR at a single-site pilot study at the Clinica de Control de la Obesidad in Santiago, Chile. None had previous bariatric surgery and all had pancreatic function.

The researchers performed thermal ablation of the duodenal mucosa with Revita. Nineteen patients received DMR over several centimeters of their duodenum, and the remainder over a shorter segment. HbA1c, fasting glucose change and weight change was evaluated at 1 and 3 months.

Patients demonstrated greater HbA1c improvements with treatment over the long segment compared with the short (7.02% vs. 9.66%) by the end of study; the achievements were sustained during 6 months. Fasting glucose decreased more with long than short (–67.2 mg/dL vs. –16.4 mg/dL), as did weight (–5.6 kg vs. –0.6 kg). The findings suggest the treatment effect is dose-dependent, according to a press release.

“We now know that changes that occur in the gastrointestinal tract following lifetime of eating fat and sugar,” Neto said. “Bariatric surgery has led to remarkable results in reversing diabetes. That said, it doesn’t scale as easily because it’s invasive and requires a hospital stay.”

Revita DMR can be performed in an hour, Neto said.

A multicenter, prospective, double blind, sham-controlled study is slated to start in December, with sites throughout Europe and South America, Neto said. Fractyl expects to start its US study in 2016, he added.

“If the data remain consistent with the early, highly encouraging results, we believe this could be the first scalable solution to reduce the burden of type 2 diabetes,” Neto said. — by Allegra Tiver

Disclosure: This study was funded by Fractyl Laboratories Inc.