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1300 859 059
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Are you looking for a new way to help control your Type 2 Diabetes?

The BMI Clinic is conducting a clinical trial evaluating a new, non-surgical procedure that may interest you.

Enquire Now

Type 2 Diabetes 

Type 2 Diabetes is a progressive disease in which the body has difficulty maintaining normal blood sugar (glucose) levels. Over time, excess sugar in the blood can damage blood vessels, kidneys, and other tissues in  the body, causing complications such as high blood pressure, heart disease, stroke, neuropathy, kidney  damage, eye damage and foot ulcers among others. 

Normalizing and controlling blood glucose levels can prevent or slow down the progression of the disease and  is a primary goal of diabetes management.

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Role of the duodenum in regulating blood glucose levels 

The duodenum is the first part of the small intestine. It connects the stomach to the rest of the digestive  tract.

As the first absorptive part of the digestive tract that sees the intake of food, the duodenum plays an  important role in signaling the rest of the body to prepare for the nutrients that it is about to receive. 

In patients with Type 2 Diabetes, the cells in the duodenal lining, or mucosa, that are responsible for this  signaling are not functioning properly; this can contribute to an imbalance in blood sugar levels.

What is Duodenal Mucosal Regeneration (DMR) 

Duodenal Mucosal Regeneration or DMR is an endoscopic procedure that is designed to eliminate these poorly functioning cells in the mucosa so the body will regrow new cells that signal properly. This is intended to help the body better regulate blood sugar levels. 

The DyaMX Procedure 

The DyaMX DMR procedure is done in an endoscopy suite in a hospital or an outpatient center. Patients  will be under general anesthesia for the procedure. During the procedure, a specialized doctor called a  gastroenterologist, will use a small flexible camera (endoscope) to guide a special catheter through the  mouth and past the stomach into the duodenum. This catheter is designed to apply pulsed electric fields  across the mucosa, or lining, of the duodenum. These electric fields will destabilize the targeted cells of the  mucosa and initiate the regeneration or regrowth of healthy cells – including the signaling cells that help  the body manage blood glucose levels. 

Because the DyaMX procedure is done endoscopically, this means there will be no incisions (cuts or scars).

While the recovery experience is not completely known at this time most individuals should be able to go home the day of the procedure. Patients may experience some abdominal discomfort that should pass in a short time.

Normal physical activity can usually be resumed the next day.

DyaMX Procedure Call Out

The Regent-1 Clinical Trial 

The Regent-1 Clinical Trial will evaluate the safety and feasibility of the DyaMX procedure in the  treatment of patients with Type 2 Diabetes.

Am I candidate for the Regent-1 Clinical Trial? 

If you are interested in the DyaMX procedure and the REGENT-1 Clinical Trial, please complete the information below*. 

You may be eligible to be included in the study if you:

  • Are between 18 and 70 years of age.
  • Have been diagnosed with type 2 diabetes within the last 10 years.
  • Have a BMI of 24-40 kg/m2, inclusive.
  • Have HbA1C of 7.5-11.0% (58-97 mmol/mol), inclusive.
  • Are taking 1-3 non-insulin glucose lowering medications, and your medications have been stable for at least 12 weeks.
  • Your weight has been stable (less than 5% change) for at least 12 weeks.
  • Have not used any type of insulin for more than one month (at any time, except for treatment of gestational diabetes) in the last two years.
  • Do not take any steroids, blood-thinners, anti-coagulation medications (eg. warfarin), weight loss medications, or non-steroidal anti-inflammatory drugs that cannot be stopped for one month.
  • Have not had any previous gastrointestinal surgery that has changed your anatomy (eg. gastric bypass, gastric band or gastric sleeve surgery).
  • Do not have any autoimmune disease (excluding Graves' or Hashimoto's disease, with adequately replaced thyroid hormones).
  • Do not suffer from irritable bowel syndrome (IBS) or inflammatory bowel disease (eg. Crohn's disease, coeliac).
  • Do not consume excessive alcohol.
  • Meet all eligibility criteria as assessed by your study doctor.
 

As seen on 7 News

 

 

 

COVID-19 Considerations  

While participation in the clinical trial will require regular interaction with healthcare professionals, steps  will be taken to limit the exposure potential and remote visits will be utilized if necessary. 

A study coordinator will discuss these visits, and other COVID precautions, in detail with participants.

Contact

If you would like to learn more about the DyaMX procedure and the Regent-1 Clinical Trial, please call us  at: 1300 859 059 or email us at Regent@bmiclinic.com.au 

  • The DyaMX procedure is investigational and has not been approved for use in Australia out of clinical study. For a complete list of risk and benefits associated with this procedure and trial please contact the clinical site.