Impact of Metabolic Surgery on Pancreatic, Renal and Cardiovascular Health in Youth With Type 2 Diabetes (IMPROVE-T2D)
Type 2 Diabetes Mellitus, Obesity, Bariatric Surgery Candidate
About this trial
This is an interventional diagnostic trial for Type 2 Diabetes Mellitus
Eligibility Criteria
Inclusion Criteria:
- Obese youth with T2D (≥50 kg) scheduled for VSG
- Weight <550 lbs.
- BMI ≥ 35 kg/m2
- Age 12-21 years
- HbA1c ≤ 12%
Exclusion Criteria:
- T2D onset (diagnosis) > 18 years of age
- Prepubertal
- Anemia
- Seafood or iodine allergy
- Pregnancy or breastfeeding
- Claustrophobia, implantable devices (MRI contraindications)
- Recent diabetic ketoacidosis or hyperosmolar hyperglycemia
- Other causes of diabetes other than T2D
- Diuretics, sodium-glucose co-transport (SGLT) 2 or 1 blockers, daily NSAIDs or aspirin, sulfonamides, procaine, thiazolsulfone or probenecid, atypical antipsychotics or regular use of oral steroids
Additional exclusion criteria for participants undergoing optional kidney biopsy:
- Evidence of bleeding disorder or complications from bleeding
- Use of aspirin, NSAIDS or other blood thinner that cannot be safely stopped for a sufficient time period before and after the biopsy so as to add no additional risk of bleeding
- Blood urea nitrogen (BUN) > 80 gm/dL
- INR > 1.4
- PTT > 35 seconds
- Hemoglobin (Hgb) < 10 mg/dL
- Platelet count < 100,000 / µL
- Uncontrolled or difficult to control hypertension (> 150/90 mmHg at the day of biopsy)
- eGFR < 40 mL/min/1.73m2
- Single kidney (either by history, documented by prior imaging or ultrasound performed prior to the biopsy)
- > 2 cm discrepancy between left and right kidney sizes based on largest longitudinal diameter determined by ultrasound performed prior to the biopsy.
- Kidney size: One or both kidneys < 9 cm
- Hydronephrosis or other important renal ultrasound findings such as significant stone disease
- Any evidence of a current urinary tract infection as indicated on day of biopsy
- Clinical evidence of non-diabetic renal disease
- Positive urine pregnancy test or pregnancy
Sites / Locations
- Children's Hospital ColoradoRecruiting
Arms of the Study
Arm 1
Other
Clinical Investigation
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.