# First in Human Clinical Trial of Mesenteric Visceral Lipectomy in Subjects with Type 2 Diabetes and Obesity

> **NIH NIH R44** · MEDALITY MEDICAL, LLC · 2021 · $595,713

## Abstract

ABSTRACT
The First in Human Mesenteric Visceral Lipectomy (MVL) Clinical Trial will determine the safety and
efficacy of large-volume mesenteric visceral fat (VF) removal in human subjects and evaluate the effect
of that removal on glycemic control, insulin sensitivity, and body weight in subjects with T2D; the goals
of the MVL procedure are to improve glycemic control, improve insulin sensitivity and to reduce body
weight in patients with T2D. The MVL procedure employs Medality Medical's Tissue Liquefaction
Technology (TLT) to surgically remove approximately 75% of the VF located in the small bowel
mesentery in subjects with class one obesity and poorly controlled T2D, who are in a state of insulin
resistance pre-operatively as documented by a clamp test. Excess visceral fat (VF) has been strongly
linked with the development of insulin resistance and subsequent type 2 diabetes (T2D) in humans; rodent
lipectomy studies have demonstrated that this relationship is causal. Surgically removing subcutaneous
fat by large volume liposuction has been explored as a treatment approach, but the vast majority of these
studies have failed to demonstrate improvement in metabolic outcomes. Therefore, targeting VF depots
for removal should be prioritized in order to rapidly and significantly improve metabolic and overall
health in humans. The specific visceral fat depot suspected to be the main contributor to insulin resistance
and T2D is the mesentery VF depot, it is the largest of the visceral fat depots, and adipokines produced
there drain directly into the liver via the portal vein. Due to the heavy vascularization and other delicate
structures within and around the mesentery, there have been no feasible surgical methods or technologies
that would allow the safe extraction of mesenteric visceral fat from the body. Studies targeting the greater
omentum fat depot have been conducted with mixed results, likely because this depot only accounts for a
fraction of total VF mass (~5-10%) in an obese human. Thus, targeting the mesentery, where most VF is
harbored, is likely required to surgically treat T2D. Related to fulfilling that goal, we had previously
developed and commercialized TLT, which is in use for removing cataracts as well as for removing
subcutaneous fat depots. TLT's method is a unique, non-cutting patented approach that delivers low
levels of thermal and mechanical energy in a stream of warmed, low-pressurized, and pulsed saline,
which causes susceptible non-connective tissues to undergo a phase transition from solid to liquid, while
connective tissues do not, thus allowing those liquefied tissues to be removed from the body by
aspiration. Blood vessels, lymphatic vessels, and nerves have an outermost covering layer made up of
connective tissue and are thus protected, thus they are not liquefied and they remain in a solid state, intact
and unharmed. Our work has demonstrated we can effectively use TLT to surgically remove a large
volume of visceral f...

## Key facts

- **NIH application ID:** 10140340
- **Project number:** 5R44DK125159-02
- **Recipient organization:** MEDALITY MEDICAL, LLC
- **Principal Investigator:** mark andrew
- **Activity code:** R44 (R01, R21, SBIR, etc.)
- **Funding institute:** NIH
- **Fiscal year:** 2021
- **Award amount:** $595,713
- **Award type:** 5
- **Project period:** 2020-04-10 → 2023-09-30

## Primary source

NIH RePORTER: https://reporter.nih.gov/project-details/10140340

## Citation

> US National Institutes of Health, RePORTER application 10140340, First in Human Clinical Trial of Mesenteric Visceral Lipectomy in Subjects with Type 2 Diabetes and Obesity (5R44DK125159-02). Retrieved via AI Analytics 2026-05-24 from https://api.ai-analytics.org/grant/nih/10140340. Licensed CC0.

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