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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