Evaluation of Intra-Abdominal Fat Extraction Using HydraSolve T2D™ in Obese Subjects With Type 2 Diabetes
Last updated on July 2021Recruitment
- Recruitment Status
- Recruiting
- Estimated Enrollment
- 30
Summary
- Conditions
- Diabetes Mellitus - Type 2
- Insulin Resistance
- Type
- Interventional
- Phase
- Not Applicable
- Design
- Allocation: N/AIntervention Model: Single Group AssignmentIntervention 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.Masking: None (Open Label)Primary Purpose: Treatment
Participation Requirements
- Age
- Between 22 years and 75 years
- Gender
- Both males and females
Description
This study will evaluate 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 re...
This study will evaluate 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. Excess intra-abdominal mesenteric fat has been directly linked to insulin resistance, an important precursor of type 2 diabetes. Up to 30 study candidates will undergo screening and eligibility testing over a 5-week period from which 12 will be enrolled to undergo the procedure. During the 12-month period post-procedure, the patients will be periodically monitored for improvements in blood glucose control (HbA1c, oral glucose tolerance test (OGTT), fasting blood glucose (FBG) and continuous glucose monitoring (CGM)), insulin resistance (hyperinsulinemic euglycemic glucose clamp), body weight, changes in fat deposits (Magnetic Resonance Imaging (MRI) and Magnetic Resonance Spectroscopy (MRS) and Dual-Energy X-ray Absorptiometry (DEXA)) and overall metabolic health (including indirect calorimetry and various biomarkers). This prospective, single-arm study uses pre-operative patient data as the control. Safety assessments and monitoring for adverse events will be performed, throughout.
Tracking Information
- NCT #
- NCT03953963
- Collaborators
- Not Provided
- Investigators
- Principal Investigator: Ralph DeFronzo, MD University of Texas Study Director: Mark Andrew, MD Medality Medical
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