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Metabolic Surgery for Type 2 Diabetes (IMPROVE-T2D Trial)
IMPROVE-T2D Trial 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.
IMPROVE-T2D Trial Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowIMPROVE-T2D Trial Timeline
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.IMPROVE-T2D Trial Design
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Who is running the clinical trial?
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- 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.
- Group 1: Clinical Investigation
- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
- 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.
Frequently Asked Questions
Are there any vacancies left for participants in this experiment?
"Affirmative. According to clinicaltrials.gov, this study is actively enrolling participants that emerged on October 1st 2018 and was last updated in January 28th 2022. 30 patients are required at a single medical facility."
Am I eligible to partake in this research endeavor?
"To be eligible for this trial, individuals must have type 2 diabetes mellitus and fall between the ages of 12 to 21. The research team is hoping to recruit a total of 30 participants."
How many individuals are being consented to partake in this clinical experiment?
"Affirmative. The information available on clinicaltrials.gov states that this medical trial is currently seeking out candidates, starting from October 1st 2018 with its last update occurring on January 28th 2022. A total of 30 individuals need to be recruited across one site for the research project's completion."
Does this medical trial have an age limit and, if so, is it possible for senior citizens to participate?
"This medical trial is specifically looking for participants aged between 12 and 21. 474 studies are available to minors while 2163 clinical trials target the elderly population."
Who else is applying?
What state do they live in?
What site did they apply to?
What portion of applicants met pre-screening criteria?
How many prior treatments have patients received?
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