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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
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 belowSelect...
I am between 12 and 21 years old.
Select...
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:Select...
I have anemia.
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I have recently had severe complications from diabetes.
Select...
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.
Select...
My kidney function is reduced with an eGFR below 40.
Select...
My blood pressure is often higher than 150/90 mmHg.
Select...
I was diagnosed with type 2 diabetes after turning 18.
Select...
I have kidney swelling or significant kidney stones.
Select...
I have a bleeding disorder or have had complications from bleeding.
Select...
I have kidney disease not caused by diabetes.
Select...
I have not started puberty.
Select...
One or both of my kidneys are smaller than 9 cm.
Select...
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
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 moreTrial 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
2007
N/A
~110
Vertical Sleeve Gastrectomy
2009
N/A
~140
Aminohippurate Sodium Inj 20%
2018
Completed Phase 2
~130
Find a Location
Who is running the clinical trial?
University of Colorado Denver School of Medicine Barbara Davis CenterLead Sponsor
16 Previous Clinical Trials
1,149 Total Patients Enrolled
University of Colorado, DenverLead Sponsor
1,786 Previous Clinical Trials
2,787,578 Total Patients Enrolled
Petter Bjornstad, MDPrincipal Investigator - University of Colorado School of Medicine
University of Colorado, Denver
6 Previous Clinical Trials
420 Total Patients Enrolled
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I have anemia.You are afraid of small, enclosed spaces or have devices inside your body that can't be near an MRI machine.You are pregnant or have a positive urine pregnancy test.I have recently had severe complications from diabetes.Your PTT blood test takes longer than 35 seconds.My diabetes is not type 2.I am not taking diuretics, SGLT blockers, daily NSAIDs or aspirin, sulfonamides, procaine, thiazolsulfone, probenecid, atypical antipsychotics or oral steroids regularly.My kidney function is reduced with an eGFR below 40.I was diagnosed with type 2 diabetes after turning 18.I can safely stop taking aspirin, NSAIDs, or blood thinners before and after a biopsy.Your platelet count is less than 100,000 per microliter.My blood pressure is often higher than 150/90 mmHg.You have a urinary tract infection on the day of the biopsy.You are allergic to seafood or iodine.I have kidney swelling or significant kidney stones.Your blood urea nitrogen level is higher than 80 mg/dL.Your blood clotting test (INR) is higher than 1.4.Your left and right kidneys are very different in size.You weigh less than 550 pounds.You have a body mass index (BMI) of 35 or higher.I am between 12 and 21 years old.I have a bleeding disorder or have had complications from bleeding.I have kidney disease not caused by diabetes.Your hemoglobin level is less than 10 mg/dL.Your HbA1c level is less than or equal to 12%.I have not started puberty.One or both of my kidneys are smaller than 9 cm.I am a young person with type 2 diabetes and weigh over 50 kg, scheduled for vertical sleeve gastrectomy.I have only one kidney.
Research Study Groups:
This trial has the following groups:- Group 1: Clinical Investigation
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Type 2 Diabetes Patient Testimony for trial: Trial Name: NCT03620773 — Phase 1 & 2
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