A phase II clinical trial was initiated to validate the efficacy of the first endoscopic procedure that uses heat to treat type 2 diabetes, a disease that affects almost 4 million people in Italy alone. For the first time, patients could have an alternative, namely a single definitive endoscopic treatment, to the only treatment available to date, which involves a constant and increasing intake of medicines, thereby greatly improving their quality of life.

This is one of the main new developments in the endoscopic field that will be presented at the eighth edition of IMAGE (International Meeting Advanced Gastroenterology Endoscopy), the international course in endoscopy that from June 15 to 17 will bring together over 600 experts from 23 countries in Humanitas, with live sessions where the latest news in gastroenterology and endoscopy will be addressed.

The course is directed by three Humanitas specialists: Prof. Alessandro Repici, Head of Digital Endoscopy, Prof. Silvio Danese, Head of the Center for Chronic Inflammatory Diseases of the Intestine and Prof. Alberto Malesci, Director of the Department of Gastroenterology.


The clinical trial that uses heat for diabetes

The randomized clinical trial, which will be presented at IMAGE, aims to validate the efficacy of a new endoscopic technique: “rejuvenation of the duodenal mucosa” (DMR), to treat type 2 diabetes. The technique (which was developed by Fractyl Laboratories Inc.) has already shown positive results on the hundred patients involved in the early stages of the study. Humanitas, together with the Fondazione Policlinico Universitario A. Gemelli is the only Italian center to be part of a network of 15 excellent European centers in the field of endoscopy.

Thanks to this technique it would be possible to reduce and then stabilize potentially definitively the blood sugar level, avoiding the continuous and increasing intake of drugs, which in the most advanced stages involves the administration of injections of insulin several times a day.

The treatment acts on the duodenum, an organ considered crucial in the development of diabetes, to restore its normal function: heat is used to thicken and regenerate the intestinal mucosa, restoring the normal composition of hormones produced by the intestine and improving the control of blood sugar and, therefore, diabetes.


Endoscopy beyond the gastroenterological field

“Endoscopy is constantly evolving from diagnosis to minimally invasive treatment of benign and malignant diseases for which only surgery was previously an option. Now, thanks to the increasing skills, new techniques and tools used, it is possible to expand the scope of application, to go beyond the strictly gastroenterological and represent a valid therapeutic alternative for diseases such as diabetes, fatty liver and obesity. For this reason, we are particularly pleased to take part in this study, which is the first case of application outside of classical pathologies – comments Prof. Alessandro Repici.


Study details

So far, over one hundred patients have been treated worldwide in phase 1 of the study, seven of whom at the A. Gemelli University Hospital in Rome, by the team led by Prof. Guido Costamagna, director of Surgical Digital Endoscopy and director of the Institute of Clinical and Surgical Therapy at the Catholic University of Rome.

The therapy was well tolerated and risk-free, with significant improvements in parameters including blood sugar, glycogenated hemoglobin and liver enzymes in most patients.

“The experimental phase – says Professor Costamagna – will be concluded in about two years; if the results are positive, this innovative treatment can be extended to all those patients with diabetes who are unable to control the therapy with drugs and who make up about half of the total number of patients.

The study involves the enrollment of patients between 28 and 74 years of age, suffering from type 2 diabetes, in therapy with oral anti-diabetic drugs but not yet subjected to insulin, with values of glycated hemoglobin (HbA1c) between 7.5 and 10%.