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Procedure

Metabolic Surgery for Type 2 Diabetes (IMPROVE-T2D Trial)

Phase 1 & 2

Waitlist Available

Led By Petter Bjornstad, MD

Research Sponsored by University of Colorado Denver School of Medicine Barbara Davis Center

Eligibility Criteria Checklist

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

Must have

Age 12-21 years

Obese youth with T2D (≥50 kg) scheduled for VSG

Must not have

Anemia

Recent diabetic ketoacidosis or hyperosmolar hyperglycemia

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 60 min

Awards & highlights

No Placebo-Only Group

Summary

This trial is testing whether or not a vertical sleeve gastrectomy, a type of weight loss surgery, can help improve Type 2 diabetes in youth by looking at changes in things like insulin resistance, glycemic control, beta-cell function, and cardiovascular health.

Who is the study for?

This trial is for obese youth aged 12-21 with Type 2 Diabetes, scheduled for vertical sleeve gastrectomy (VSG), and a BMI ≥35 kg/m2. Participants must have an HbA1c ≤12% and weigh less than 550 lbs. They cannot be on certain medications like diuretics or blood thinners that can't be stopped safely around the time of surgery.

What is being tested?

The study tests how bariatric surgery (specifically VSG) affects pancreatic function, kidney health, and cardiovascular wellness in young people with Type 2 Diabetes. It includes measuring various body functions before and after surgery to see improvements.

What are the potential side effects?

Potential side effects may include complications from renal biopsy such as bleeding or infection, reactions to contrast agents used in imaging tests, surgical risks associated with VSG including pain, infection, bleeding, and possible adverse reactions to anesthesia.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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I am between 12 and 21 years old.

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I am a young person with type 2 diabetes and weigh over 50 kg, scheduled for vertical sleeve gastrectomy.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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I have anemia.

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I have recently had severe complications from diabetes.

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My diabetes is not type 2.

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I am not taking diuretics, SGLT blockers, daily NSAIDs or aspirin, sulfonamides, procaine, thiazolsulfone, probenecid, atypical antipsychotics or oral steroids regularly.

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My kidney function is reduced with an eGFR below 40.

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My blood pressure is often higher than 150/90 mmHg.

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I was diagnosed with type 2 diabetes after turning 18.

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I have kidney swelling or significant kidney stones.

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I have a bleeding disorder or have had complications from bleeding.

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I have kidney disease not caused by diabetes.

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I have not started puberty.

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One or both of my kidneys are smaller than 9 cm.

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I have only one kidney.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 60 min

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~60 min

This trial's timeline: 3 weeks for screening, Varies for treatment, and 60 min for reporting.

Treatment Details

Study Objectives

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

Primary study objectives

Effective Renal Plasma Flow (ERPF)

Glomerular Filtration Rate (GFR)

Pancreatic β-cell function

Secondary study objectives

Aortic Stiffness & Wall Shear Stress

Renal Oxygenation

Renal Perfusion

Other study objectives

Detachment and endothelial fenestration of glomeruli

Epigenetic profiling

Foot process width of glomeruli

+3 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: Clinical InvestigationExperimental Treatment4 Interventions

Participants will include youth who are scheduled for, and will undergo, vertical sleeve gastrectomy (VSG) surgery at the Bariatric Surgery Clinic at Children's Hospital of Colorado. To understand how bariatric surgery affects renal function, all participants will undergo assessment of Glomerular Filtration Rate, (Iohexol Inj 300 mg/mL) and Effective Renal Plasma Flow (Aminohippurate Sodium Inj 20%). In addition, participants will undergo imaging assessment that includes renal Blood Oxygen Level Dependent (BOLD) and Arterial Spin Labeling (ASL) MRI.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Iohexol Inj 300 mg/mL

2018

Completed Phase 2

~50

Renal Biopsy

2016

Completed Phase 2

~200