HydraSolve T2D for 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

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial aims to determine if a new procedure can help control blood sugar in people with obesity and type 2 diabetes who haven't succeeded with oral diabetes medications. The procedure uses the HydraSolve T2D™ system, a specialized device, to safely remove excess abdominal fat, potentially improving insulin resistance and glucose levels. It suits individuals who have had type 2 diabetes for 10 years or less, are not using insulin, and live in the San Antonio, TX, area. As an unphased trial, this study provides a unique opportunity to explore innovative treatments for managing diabetes.

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.

What prior data suggests that the HydraSolve T2D™ System is safe for improving blood glucose control and insulin resistance?

Studies have shown that mesenteric visceral lipectomy (MVL) can safely remove fat from around internal organs. This procedure uses a technology called tissue liquefaction. In animal studies, this method did not harm nearby tissues. For humans, early research on the HydraSolve T2D™ System, initially approved for liposuction and fat transfer, also supports its safety for similar procedures. Although these studies have reported no major side effects, using this method to improve glucose control in diabetes remains experimental. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Most treatments for type 2 diabetes focus on managing blood sugar levels through medication, diet, and exercise. However, HydraSolve T2D™ offers a unique approach by targeting and extracting excess intra-abdominal fat from the mesentery using a minimally invasive procedure. Researchers are excited about this technique because it directly addresses obesity, a major contributor to type 2 diabetes, potentially improving insulin sensitivity and metabolic health. This innovative method could offer a new avenue for managing type 2 diabetes beyond traditional medication and lifestyle changes.

What evidence suggests that the HydraSolve T2D™ System is effective for improving blood glucose control in patients with type 2 diabetes?

Research has shown that the HydraSolve T2D™ System, which participants in this trial will receive, can help people with type 2 diabetes manage blood sugar by removing certain abdominal fat. In earlier studies, removing this fat led to a 1.7% reduction in total body fat after a year and a slight drop in body weight. This method, called mesenteric visceral lipectomy (MVL), has shown promise in improving the body's ability to handle sugar. The procedure is minimally invasive, involving only small cuts, and successfully removed up to 80% of visible fat in the mesentery (a fold of tissue in the abdomen) without causing problems. These findings suggest that HydraSolve T2D™ could be a promising option for those struggling to control their blood sugar. ^{3 4 6 7 8}

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+

Citations

1. withpower.com withpower.com/trial/phase-diabetes-mellitus-9-2019-8a656

Evaluation of Intra-Abdominal Fat Extraction Using ... 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 ...

2. academic.oup.com academic.oup.com/jcem/article/110/9/e3070/7926906

Mesenteric Visceral Lipectomy Improves Glucose Tolerance in ... Whole-body percent fat did not change at 6 months but decreased by 1.7% (P = .003) at month 12 (Table 1). Body weight decreased slightly at months 6 and 12 (P < ...

3. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC6391994/

Mesenteric Visceral Lipectomy using Tissue Liquefaction ... We were able to remove up to 75–80% of all visible adipose tissue in the mesentery without complications, which we estimate to be ~40% of total VF stores, ...

4. biospace.com biospace.com/andrew-technologies-inc-announces-world-s-first-successful-mesenteric-fat-extraction-a-long-awaited-breakthrough-for-potential-reversal-of-diabetes

Andrew Technologies, Inc. Announces World's First ... Announces World's First Successful Mesenteric Fat Extraction, A Long-Awaited Breakthrough For Potential Reversal Of Diabetes. October 17 ...

5. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/39689013/

Mesenteric Visceral Lipectomy Improves Glucose Tolerance in ... Conclusion: Mesenteric visceral lipectomy (MVL) shows potential as a novel, minimally invasive approach to improve glycemic control in patients ...

6. clinicaltrials.gov clinicaltrials.gov/study/NCT03953963?cond=Diabesity&viewType=Table&rank=7

Evaluation of Intra-Abdominal Fat Extraction Using ... An unfavorable change in the health of a participant, including abnormal laboratory findings, that happens during a clinical study or within a certain amount of ...

7. aging.networkofcare.org aging.networkofcare.org/sanmateo/CommunityResources/ClinicalTrials/Detail/NCT03953963?keyword=%22T2D%22

San Mateo Clinical Trial Evaluation of Intra-Abdominal Fat ... This study will evaluate the investigational use of the HydraSolve T2D™ System (previously FDA-cleared for liposuction and fat transfer) to perform a novel, ...

8. researchgate.net researchgate.net/publication/323658143_Mesenteric_visceral_lipectomy_using_tissue_liquefaction_technology_reverses_insulin_resistance_and_causes_weight_loss_in_baboons

Mesenteric visceral lipectomy using tissue liquefaction ... Thus, these data demonstrate that mesenteric fat can be safely targeted for removal by tissue liquefaction technology in a nonhuman primate ...