UT Health San Antonio Leads Clinical Trial Testing Procedure Aimed at Reversing Type 2 Diabetes

UT Health San Antonio Leads Clinical Trial Testing Procedure Aimed at Reversing Type 2 Diabetes

A team of investigators from the University of Texas Health Science Center at San Antonio (also referred to as UT Health San Antonio), University Health, and Texas Biomedical Research Institute are reporting promising results following a minimally invasive procedure that dissolved abdominal fat in two patients. The goal of the novel procedure is to improve the patients’ health and minimize or reverse the adverse health effects of their Type 2 diabetes. The clinical trials are authorized by the U.S. Food and Drug Administration (FDA) via an Investigational Device Exemption. The inventor of the device, Dr. Mark Andrew, an ophthalmologist in Pennsylvania, desired the participation of the San Antonio trial sites in part due to the reputation of Dr. Richard Peterson in the field of metabolic and bariatric weight loss surgery, as well as the expertise of Dr. Ralph DeFronzo, MD, is a world-renowned endocrinologist and serves as chief of diabetes at UT Health San Antonio and deputy director of University Health’s Texas Diabetes Institutes.

A TrialSite Note on the Health & Wellness Crisis

The Centers for Disease Control and Prevention reports that “Healthy eating is your recipe for managing diabetes.” With over 34 million Americans struggling with diabetes, about 90-95% of them have type 2 diabetes. Type 2 diabetes most often develops in people when they pass the age of 45, but increasingly, teens and even children are diagnosed with the condition based on CDC guidance.

TrialSite ponders the correlation between obesity and type 2 diabetes. The links are so intertwined and interdependent that the term “Diabesity” has been coined. According to one academic account here:

“The passage from obesity to diabetes is made by a progressive defect in insulin secretion coupled with progressive rise in insulin resistance. Both insulin resistance and defective insulin secretion appear very prematurely in obese patients, and both worsen similarly towards diabetes. This, the classic hyperbolic relationship between insulin resistance and insulin secretion and the ‘glucose allostasis concept’ remain prevailing concepts in this particular field of knowledge. An increase in overall fatness, preferentially of visceral as well as ectopic fat depots, is specifically associated with insulin resistance. The accumulation of intramyocellular lipids may be due to reduced lipid oxidation capacity. The ability to lose weight is related to the capacity to oxidize fat. Thus, a relative defect in fat oxidation capacity is responsible for energy economy and hampered weight loss.”

Comprehensive health and wellness must be taught in the schools as insufficient numbers of Americans, and increasingly in other parts of the world, understand how to take care of themselves or what’s a healthy lifestyle.

Ideally, that’s taught in the home to the malleable young, but unfortunately many people didn’t have that benefit. There needs to be sufficient numbers to make the case that a whole new focus on health and wellness represents a national interest. The COVID-19 pandemic has contributed to this need for a health and wellness national reckoning, from primary school to workplace. But for many now that are obese and with subsequent comorbidities, such as Type 2 diabetes, various therapeutic regimens are considered.

The Context

Published recently by UT Health San Antonio newsroom, the prestigious Texas academic medical center first shared that abdominal fat, the proverbial tire around the middle of so many Americans, is unhealthy. It is associated with diabetes, cardiovascular disease, fatty liver disease, insulin resistance, hypertension, poor lipid profile and more.

The Texas collaborators we brought into this study due to their reputation for excellence. The device used in these studies is owned and patented by Dr Mark Andrew, an ophthalmologist in Pennsylvania, who desired the participation the San Antonio trial site in part due to the reputation of Dr. Richard Peterson in the field of metabolic and bariatric weight loss surgery, as well as the expertise of Dr. Ralph DeFronzo, MD, is a world-renowned endocrinologist and serves as chief of diabetes at UT Health San Antonio and deputy director of University Health’s Texas Diabetes Institutes.

The Technique & The Investigational Device

The mesenteric visceral lipectomy technique, or MVL, extracts fat from the mesentery, a sheet of tissue that is attached to the intestines. The surgeon makes a small abdominal incision and uses a patented, proprietary medical device to dissolve the glycoproteins (or glucose) that hold the fat together. The same device suctions out the fat without affecting the blood vessels or surrounding tissues.

“This is important because the fat in our abdomen contains numerous blood vessels,” Richard Peterson, MD, said. “This technique allows the fat to be removed surgically without significant bleeding. Once the fat is loose, it is suctioned out.”

The first procedure of its kind in University Hospital back in November of 2019, Dr. Richard Peterson, MD, a chief of metabolic and bariatric surgery at UT Health San Antonio and a bariatric surgeon practicing at University Hospital, performed the procedure as part of a 10-person first-in-human clinical trial of MVL. Serving as the trial’s principal investigator, Ralph DeFronzo, MD, is a world-renowned endocrinologist and serves as chief of diabetes at UT Health San Antonio and deputy director of University Health’s Texas Diabetes Institutes.

First MVL patients

A man in his mid-30s with diabetes was the first patient anywhere to receive the MVL procedure. The medical team at the Texas Diabetes Institute identified him as a good candidate.

“Because he was the first subject, we only removed 30% of the visceral fat,” Dr. DeFronzo said, explaining that the goal with future patients is the removal of as much as 90% of the fat. “Nonetheless, he had a modest improvement in insulin sensitivity. His glucose tolerance and HbA1c (hemoglobin A1c) did not change, but he required less diabetes medication.”

“People that young, suffering from diabetes for the rest of their lives, deserve a better chance,” Dr. Peterson said. “At the time of the first surgery, it came to me that he was our ‘Neil Armstrong,’ if you will. No one in the world had ever had this done, and he was leading the way for the rest of the world.”

Although the COVID-19 pandemic delayed this and other elective surgeries, Dr. Peterson and his team have now performed a second MVL procedure on a female patient at Foundation Surgical Hospital of San Antonio, and are observing the effects it will have on her health.

Following surgery, the patients remain overnight in the hospital for observation. Follow-up studies are performed at the Texas Diabetes Institute. The U.S. Food and Drug Administration (FDA) granted an Investigational Device Exemption in authorizing the clinical trial.

The Study Hypothesis

The team hypothesizes that by removing the visceral fat, diabetes will improve, and the inflammation produced by the abdominal fat will be reduced, which will slow down arterial disease.

“Fat releases hormones and other substances that cause damage to the liver, the arterial system and beta cells that produce insulin,” Dr. DeFronzo said. “When people get fat, they get fat everywhere in their body, but the fat that is really dangerous is the fat that is within the abdomen.”

The Investigational Device

The MVL technology was originally developed to remove eye cataracts, and was adapted for this new purpose by Mark Andrew, MD, an ophthalmologist in Pennsylvania and the inventor of the device. Dr. Andrew selected San Antonio collaborators to test the concept because of Dr. Peterson’s reputation in metabolic and bariatric weight loss surgery and the expertise of Dr. DeFronzo.

Preclinical Research at Texas Biomed

The doctors then enlisted the Southwest National Primate Research Center at Texas Biomedical Research Institute (Texas Biomed) as the site of large-animal studies that the FDA required before authorizing the clinical trial in people.

Dr. Peterson, working with co-investigators Raul Bastarrachea, MD, and Patrice Frost, DVM, of Texas Biomed, proved the technique’s safety and efficacy in baboons, greatly benefiting the animals.

The baboon study was exciting. All four animals treated with MVL surgery survived without any complications and all had remission of Type 2 diabetes.

“I do bariatric and metabolic surgery to treat Type 2 diabetes patients, and I was surprised to see such a dramatic effect on lowering the blood glucose,” Dr. Peterson said, referring to a drop in blood sugar levels. “That gave us enough momentum to push this forward to the FDA and design a clinical trial in people with Dr. DeFronzo and his team.”

Lead Research/Investigator

Ralph DeFronzo, MD, Diabetes Division chief, Professor

Dr. Richard Peterson, MD, Chief of metabolic and bariatric surgery at UT Health San Antonio and a bariatric surgeon practicing at University Hospital

Call to Action: The MVL surgery is for obese patients whose body mass index, BMI, is between 30 and 40. To ask about study eligibility, call the Texas Diabetes Institute’s research line at 210-358-7200 and ask for Mary Samano.

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