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Procedure
HydraSolve T2D™ for 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
- Type 2 Diabetes
- Insulin Resistance
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
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 moreAwards & 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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Who is running the clinical trial?
Medality MedicalLead Sponsor
Ralph DeFronzo, MDPrincipal InvestigatorUniversity of Texas
11 Previous Clinical Trials
1,018 Total Patients Enrolled
Mark Andrew, MDStudy DirectorMedality Medical
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