Type 2 Diabetes
Revitalize 1 Study
The Cleveland Clinic London, led by Dr Rehan Haidry, are undertaking a ground-breaking study of a pioneering endoscopic procedure for patients with type 2 diabetes (T2D) who are taking insulin.
The Revitalize 1 Study is evaluating an investigational clinical procedure called duodenal mucosal resurfacing, known as ‘DMR’. The DMR procedure called Revita→ is a possible new treatment for people with T2D. It targets the first part of the small intestines, known as the duodenum, which has been found to be dysfunctional in people with T2D.
This page provides background information about T2D, in particular the role of the duodenum, how the DMR procedure works, and information about the Revitalize 1 study taking place at Cleveland Clinic London (CCL).
The role of the duodenum
T2D is a progressive metabolic disease for most patients, who often struggle to control their blood sugar day-to-day and find themselves taking more medication over time. There is a huge impact on quality of life for the individual, as well as a huge economic burden on the national health service.
Traditionally, T2D treatments have focused on managing the key symptom of the disease – the high blood sugar – but they do not address why the disease is getting steadily worse. However, cutting edge research is turning its attention to a part of the digestive tract called the duodenum that researchers believe has a major role in T2D.
The duodenum is the first part of the small intestine just (after the stomach) and it plays a crucial role in metabolism. The lining of the duodenum is known as the ‘mucosa’ and it helps send signals to other parts of the body to control appetite and blood sugar levels in response to our diet.
In patients with T2D, the lining becomes thickened and researchers believe the communication between the gut and the body becomes abnormal. This abnormal lining has been linked to other problems such as obesity and fatty liver disease. Experts have shown that by ‘resurfacing’ the abnormal lining of the duodenum through an endoscopic procedure, they are able to improve T2D.
What is DMR?
DMR is a pioneering endoscopic procedure which targets the duodenum.
It uses heat to remove the thickened lining of the duodenum, allowing the body to restore a healthy mucosal layer.
This process appears to improve the ‘signalling’ to other parts of the body, like the pancreas. Patients in previous studies have seen sustained improvements in their blood glucose control.
During the procedure, the patient will be sedated and then an endoscope (a small flexible tube with a light and camera on the end) is passed down the back of the throat, through the oesophagus (the food pipe) to the duodenum
The DMR catheter (a the thin flexible tube which looks like a long thin balloon) is filled with hot water which heats the mucosa (this removes the thickened lining)
The procedure takes approximately one hour under general anaesthesia in a standard endoscopy suite and patients can expect to return home the same day or the next day
Revita targets the thickened or diseased lining of the duodenum, so the body can regrow a new healthy lining (capable of potentially helping to control blood glucose, improve insulin resistance, and improve control of diabetes without needing to take more medicines or insulin)
After the procedure patients follow a diet plan to allow the duodenum to heal
Once the duodenum is healed, patients can restart a normal diet but it is important to establish new healthy eating habits to maintain good diabetic control
Dr Haidry was the first clinician in the UK to carry out the procedure and is one of a handful of doctors worldwide to have significant experience in DMR. As well as being a leading investigator in previous clinical trials, Dr Haidry will be leading the Cleveland Clinic’s involvement in a new study called Revitalize 1.
Questions and Appointments
For any enquiries about conditions, tests or treatments, please feel free to call Dr Rehan Haidry’s medical secretary Debra Hyams.
During the procedure, the patient will be sedated and then an endoscope (a small flexible tube with a light and camera on the end) is passed down the back of the throat, through the oesophagus (the food pipe) to the duodenum.
What do researchers know about DMR?
DMR is a novel approach to T2D; it makes changes to a specific part of the gut, rather than simply trying to control the symptom of uncontrolled blood sugar.
Previous studies have shown that this procedure is effective in improving blood glucose and broader metabolic changes.
In one small study, T2D patients who were injecting insulin were able to eliminate or reduce their insulin medication. Revitalize 1 is a global study which hopes to recruit hundreds of patients with T2D who currently use insulin to provide more evidence that the procedure can reduce, or even completely avoid, the need for insulin injections.
Is Revitalize 1 right for me?
If you have type 2 diabetes and are on insulin, are aged 21-70, and have a BMI of 24-40 then you may be suitable for the Revitalize 1 clinical trial that is currently recruiting patients to have the procedure at the Cleveland Clinic London.
If you would like to take part in the Revitalize 1 clinical trial, please contact the research team via CCLEndoscopyResearch@CCF.org.
The DMR procedure is also available to private patients at the Cleveland Clinic Hospital in London. Link to: Book an appointment
Get In Touch
For any enquiries about conditions, tests or treatments, please feel free to call Dr Rehan Haidry’s medical secretary Debra Hyams on:
Tel: 0203 423 7609 | Email: rhaidrymedsec@ccf.org