Purpose

This study will investigate the safety and efficacy of the investigational use of the HydraSolve T2D™ System in improving blood glucose control and insulin resistance in patients with obesity (Class 1, BMI 30-39.9 kg/m2) and type 2 diabetes who have not achieved targeted levels of blood glucose control using oral diabetes medications. The previously FDA-cleared (for liposuction and fat transfer) HydraSolve T2D™ System will be used to perform a novel, minimally invasive laparoscopic and mini-laparotomy procedure to selectively remove excess intra-abdominal fat from the mesentery (Mesenteric Visceral Lipectomy (MVL)), while not affecting surrounding tissues. The study will include several weeks of screening for eligibility before the intervention, and 12-months of follow-up post-surgery.

Category

IRB Number
20190076HU
NCT Number
NCT03953963
Open to Enrollment
Yes
Sponsor
Medality Medical -



Study Contact

Andrea Hansis-diarte
+1 (210) 617-5300
hansisdiarte@uthscsa.edu

Principal Investigator
Ralph DeFronzo

Ralph DeFronzo
(210) 567-6691
defronzo@uthscsa.edu

Andrea Hansis-diarte
+1 (210) 617-5300
hansisdiarte@uthscsa.edu

Richard Peterson
(210) 567-2164
petersonr3@uthscsa.edu



Eligibility

Eligible Ages
Between 22 Years and 75 Years
Eligible Genders
All
Accepts Healthy Volunteers
No

Inclusion Criteria

    Exclusion Criteria


      Study Design

      Phase
      N/A
      Study Type
      Interventional
      Allocation
      N/A
      Intervention Model
      Single Group Assignment
      Intervention Model Description
      Patients will be experimental subjects, they will serve as their own controls by comparing their pre-op status to their post-op status in the parameters of investigation which include insulin status assessment (resistance versus sensitivity, as determined by hyperinsulinemic euglycemic clamp), measurements of glycemic control of T2D, and body weight measurements.
      Primary Purpose
      Treatment
      Masking
      None (Open Label)
      Condition
    1. Diabetes Mellitus, Type 2
    2. Insulin Resistance

      3. Arm Groups

      ArmDescriptionIntervention
      Experimental

      Intra-Abdominal Mesenteric Fat Extraction Group

      		All enrolled patients will undergo the combined minimally invasive laparoscopic and mini-laparotomy procedure to selectively extract excess intra-abdominal fat from the mesentery.
    3. Device: HydraSolve T2D™

      The HydraSolve T2D™ System will be used to perform the combined minimally invasive laparoscopic and mini-laparotomy procedure to selectively extract excess intra-abdominal fat from the mesentery. All patients will receive standard nutritional counseling and their medications will be adjusted to achieve target levels of blood glucose control.

      4.