It is called Revita2: it is the study that involves nine renown international centers worldwide, including Humanitas, for the experimental treatment of type 2 diabetes with a new technique of advanced endoscopy called remodeling of the duodenal mucosa, the first tract of the small intestine.
In Humanitas the study is coordinated in a multidisciplinary way by three operational units: endoscopy directed by Professor Alessandro Repici, diabetology coordinated by Professor Cesare Berra and endocrinology led by Professor Andrea Lania.
Humanitas participates through the enrolment of 15 patients and their follow-up for a total duration of 3 years and the first updates are available: the treatment in the first patients has been completed, the course has been very favorable and the discharge occurred during the day.
“The completion of all the phases of the study will allow in a short time to evaluate the validity of the experimental procedure. By optimizing the resources of the Centre we have improved the comfort and welcome of the patient, thus ensuring that those involved in the study have a point of reference to turn to, but also safety and continuity of care,” explains Professor Repici.
The new technique of remodeling the duodenal mucosa
The remodeling of the duodenal mucosa is an esophagogastroduodenoscopy that uses a specific device capable of delivering heat to the duodenal mucosa, in a timely and accurate manner and for a very short time. By acting on the intestinal mucosa, the heat restores the normal composition of hormones produced by the intestine, thus improving the control of blood glucose and consequently of diabetes.
Recent studies have shown that the hypercaloric diet causes changes in the duodenal mucosa, with consequent alteration of some hormonal signals that regulate blood glucose, contributing first to the resistance to insulin hormone (the main regulator of blood glucose), then to the dysfunction of the beta cells of the pancreas that produce the hormone and finally to the onset of type 2 diabetes.
Lifestyle and Drug Therapy against Type 2 Diabetes
Currently, type 2 diabetes is controlled by non-pharmacological therapy (diet and physical activity) and drugs that can be taken orally or intravenously. Several classes of drugs are available, increasingly specific, but still too many patients do not achieve the desired metabolic control goal.
Alternative therapies are therefore increasingly necessary to achieve more lasting results, and the new technique of remodeling the duodenal mucosa is part of this attempt.
The Revita2 study
The study involves the recruitment of voluntary patients between 28 and 75 years of age suffering from type 2 diabetes, undergoing therapy with oral antidiabetic drugs, not subjected to intravenous therapy, with glycated hemoglobin values between 7.5 and 10% (index of altered metabolic compensation).
The study is divided into several phases:
Pre-screening phase: Evaluation of patient documentation and clinical history.
Screening phase: Evaluation with the team of diabetology and endocrinology through blood analysis, magnetic resonance imaging and glycemic curve measurement (MMTT).
Endoscopic procedure (DMR) performed by the endoscopy team.
Follow up: checks and visits with diabetes/endocrinology teams.
Diabetes is a complex metabolic disease characterized by an increase in blood sugar levels. It is estimated that around 382 million people in the world suffer from diabetes; in Italy alone almost 4 million individuals are diabetic, but probably about one million are affected without knowing it.
The vast majority (about 95%) of people have type 2 diabetes, which includes a set of metabolic syndromes that share a condition called hyperglycemia. Among the factors that contribute to the development of the disease are genetic predisposition (family history), obesity, a sedentary lifestyle and a diet high in sugar and fat.
Type 2 diabetes is primarily an important risk factor for the development of cardio-cerebrovascular diseases (myocardial infarction, stroke/ stroke) as well as so-called microvascular complications that can lead to blindness, kidney failure and dialysis, and peripheral neuropathies.