Evaluation of Intra-Abdominal Fat Extraction Using HydraSolve T2D™ in Obese Subjects With Type 2 Diabetes

Overseen By Carolina Solis-Herrera, MD

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Medality Medical

Must be taking: Oral hypoglycemics

Must not be taking: Insulin, Anticoagulants

Disqualifiers: Premenopausal, Tobacco, Psychiatric, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: Unknown

12 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial will test a special device to remove specific abdominal fat in obese patients with type 2 diabetes who haven't controlled their blood sugar with pills. The goal is to see if removing this fat helps improve insulin use and lower blood sugar levels.

Do I need to stop taking my current medications for the trial?

The trial requires that you do not take any medications that can influence blood sugar control unless your doctor specifically tells you to. You also need to report all medications you are taking and avoid herbal or dietary supplements during the study.

Who Is on the Research Team?

Ralph DeFronzo, MD

Principal Investigator

University of Texas

Mark Andrew, MD

Principal Investigator

Medality Medical

Are You a Good Fit for This Trial?

Inclusion Criteria

3. Male or female between 22 - 75 years of age. (Caveat: premenopausal women are excluded)

4. In good general health except for being diagnosed as having T2D,and in good enough general health to undergo a conversion from a mini-laparotomy to an open laparotomy incision if that conversion becomes necessary during the operative procedure; the subject has no major system disease other than T2D as determined by physical examination, medical history, screening laboratory tests, and EKG.

6. Stable body weight during the 6 month time period preceding the anticipated surgery date. (Stable is defined as: the usual baseline body weight of the subject +/- < 5% change.)

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

5 weeks

Treatment

Participants undergo a minimally invasive laparoscopic and mini-laparotomy procedure to selectively remove excess intra-abdominal fat from the mesentery

Follow-up

Participants are monitored for safety and effectiveness after treatment, including assessments of blood glucose control, insulin resistance, body weight, and metabolic health

12 months

What Are the Treatments Tested in This Trial?

Interventions

• HydraSolve T2D™

How Is the Trial Designed?

Group I: Intra-Abdominal Mesenteric Fat Extraction Group Experimental Treatment 1 Intervention

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

Who Is Running the Clinical Trial?

Medality Medical

Lead Sponsor

Trials

1

Recruited

10+