Evaluation of Intra-Abdominal Fat Extraction Using HydraSolve T2D™ in Obese Subjects With Type 2 Diabetes
Lay Description
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
- Diabetes
- IRB Number
- 20190076HU
- NCT Number
- NCT03953963
- Open to Enrollment
- Yes
Eligibility
- Eligible Ages
- Between 22 Years and 75 Years
- Eligible Genders
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
Exclusion Criteria
Study Design
Arm Groups
Study Contact
Regulatory Point of Contact
Eugenio Cersosimo
(210) 358-7200
cersosimo@uthscsa.edu
Regulatory Point of Contact
Ralph DeFronzo
(210) 567-6691
defronzo@uthscsa.edu
Regulatory Point of Contact
Andrea Hansis-diarte
+1 (210) 617-5300
hansisdiarte@uthscsa.edu
Regulatory Point of Contact
Richard Peterson
(210) 567-2164
petersonr3@uthscsa.edu
Local Recruitment Point of Contact
Eugenio Cersosimo
(210) 358-7200
cersosimo@uthscsa.edu
Local Recruitment Point of Contact
Andrea Hansis-diarte
+1 (210) 617-5300
hansisdiarte@uthscsa.edu
Principal Investigator
Ralph DeFronzo