A phase-2 clinical trial has been launched. It is going to evaluate the efficacy of the first endoscopic procedure using heat to treat type-2 diabetes. A disease that affects almost 4 million people in Italy. For the first time, patients may have an alternative to the traditional therapy. A therapy that consists in a constant, increasing intake of medications. This will make patients’ lives way better.
This is one of the main endoscopic developments that was presented on the occasion of the eight edition of IMAGE (International Meeting Advanced Gastroenterology Endoscopy). An international endoscopy course that took place on 15-17 June at Humanitas, hosting more than 600 experts from 23 countries, with live sessions about the latest developments in gastroenterology and endoscopy. The course was directed by three specialists working at Humanitas. Prof. Alessandro Repici, Supervisor of Digestive Endoscopy, Prof. Silvio Danese, Supervisor of the Chronic Inflammatory Bowel Disease Center, and Prof. Alberto Malesci, Director of the Gastroenterology Department.
The clinical trial using heat against diabetes
The randomized clinical trial presented during IMAGE, aimed to evaluate the efficacy of a new endoscopic technique. The “Duodenal Mucous Rejuvenation” (DMR) in the treatment of type-2 diabetes. This technique (developed by Fractyl Laboratories Inc.) has already shown promising results on 100 patients involved in the first steps of the study. Humanitas, together with the Foundation – University Hospital “A. Gemelli”, is the only center in Italy to be part of a 15-center European network, gathering the best centers in the field of endoscopy.
Thanks to this technique, we could to reduce and then stabilize the levels of blood sugar in a potentially definitive way. Thus, eliminating the need for patients” to constantly resort to medications, who had to take insulin more than once per day, in the most advanced stages.
This new treatment involves the duodenum, a crucial organ in the development of diabetes, by restoring its normal function. Heat will make the intestinal mucous membrane thicker and rejuvenated, thus restoring the normal composition of the hormones produced in the intestine and enhancing the control over the blood sugar levels (and consequently treating the diabetes).
Endoscopy beyond gastroenterology
“Endoscopy is constantly improving. From the diagnostic tools to the minimally invasive treatment of both benign and malignant diseases that in the past necessarily required surgery. Now, thanks to improved competencies, new techniques and tools, we can apply endoscopy to new cases apart from the strictly gastroenterological ones. It has become a valid choice for diabetes, fat liver and obesity. And for this reason, why we were so happy to participate in this study. It was the first application ever apart from the classical ones”, Prof. Alessandro Repici comments.
The details of the study
Up until now, we have treated more than 100 patients during Phase 1 of the study. Seven of these patients have been treated at University Hospital “A. Gemelli” in Rome, by a team supervised by Prof. Guido Costamagna, Director of Surgical Digestive Endoscopy and Director of Surgical Clinic and Therapy at the Catholic University in Rome.
The therapy’s tolerance is good and is also risk-free. Thus, it is significantly enhancing parameters such as sugar blood levels, glycated hemoglobin and hepatic enzymes in the majority of patients.
As Professor Costamagna says, “The trial will end in a couple of years. If the results continue to be good, we will extend this innovative treatment to the 50% of the diabetics, that can’t follow the traditional, pharmacological therapy”.
The study will enroll patients between 28 and 74 years old, with type-2 diabetes, following a therapy with oral medications but without insulin, with 7.5-10% glycated hemoglobin (HbA1c) levels.
