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

N/A

Waitlist Available

Led By Ralph DeFronzo, MD

Research Sponsored by Medality Medical

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Be older than 18 years old

Timeline

Screening 3 weeks

Treatment Varies

Follow Up through 1 year study completion

Awards & highlights

No Placebo-Only Group

Summary

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.

Eligible Conditions

Insulin Resistance
Diabetes
Type 2 Diabetes

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ through 1 year study completion

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~through 1 year study completion

This trial's timeline: 3 weeks for screening, Varies for treatment, and through 1 year study completion for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Lack of serious adverse events (SAEs)

Secondary study objectives

Change in Insulin Sensitivity

Change in blood glucose control

Body Weight Changes

+1 more

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Trial Design

1Treatment groups

Experimental Treatment

Group I: Intra-Abdominal Mesenteric Fat Extraction GroupExperimental Treatment1 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.

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