On February 5, 2019, the FDA approved Medality’s Investigational Device Exemption (“IDE”) application to undertake a human clinical trial for the extraction of excess mesenteric visceral fat to reverse T2D. On August 21, 2019 the University of Texas Health Sciences Center at San Antonio (“UTHSCSA”) Institutional Review Board (“IRB”) approved the commencement of patient screening for the clinical trial.
The clinical trial is conducted at The UT Health San Antonio.
The Principal Investigator is Ralph DeFronzo, MD, Professor of Medicine and Chief, Diabetes at UTHSCSA and Deputy Director, Texas Diabetes Institute. Dr. DeFronzo is a leading endocrinologist who has been globally recognized for his numerous research and clinical advances in type 2 diabetes. His research was instrumental in defining the role of insulin resistance in the development and progression of type 2 diabetes. The Sub-Investigator is Richard Peterson, MD, MPH, FACS, FASMBS Professor and Chief, UTHSCSA Bariatric and Metabolic Surgery and Director, University of Texas Medicine Center for Bariatric and Metabolic Surgery. Dr. Peterson was the lead bariatric surgeon on all of the surgeries performed in the primate study
This study will evaluate the safety and efficacy of the investigational use of the HydraSolve T2D™ System (previously FDA-cleared for liposuction and fat transfer) to perform a novel, minimally invasive laparoscopic and mini-laparotomy procedure to selectively remove intra-abdominal fat from the mesentery and to assess the resulting changes in blood glucose control, insulin sensitivity and body weight in 12 overweight/obese patients with type 2 diabetes. Excess intra-abdominal mesenteric fat has been directly linked to insulin resistance, an important precursor of type 2 diabetes. During the 12-month period post-procedure, the patients will be periodically monitored for improvements in blood glucose control, body weight, changes in fat deposits and overall metabolic health. Safety assessments and monitoring for adverse events will be performed, throughout.
To date, 11 patients have safely undergone the mesenteric visceral lipectomy (“MVL”) procedure using the HydraSolve T2D system. Results for the first seven patients clearly demonstrate the safety and a very promising trend in glycemic control.
The above video showcases:
• live Mesenteric Visceral Lipectomy procedure (“MVL”) performed by Dr. Peterson and Dr. Kempenich using HydraSolve T2D on an actual patient with type 2 diabetes.
• how insulin resistance, obesity and visceral fat play an important part in the development and evolution of type 2 diabetes discussed by Dr. Defronzo, principal investigator of Medality’s FDA approved First-in-Human MVL Clinical Trial,
• early findings of the MVL clinical trial.