Renal HEIR Study: Renal Hemodynamics, Energetics and Insulin Resistance in Youth Onset Type 2 Diabetes Study
Ключови думи
Резюме
Дати
| Последна проверка: | 04/30/2020 |
| Първо изпратено: | 06/27/2018 |
| Очаквано записване подадено: | 07/09/2018 |
| Първо публикувано: | 07/11/2018 |
| Изпратена последна актуализация: | 05/13/2020 |
| Последна актуализация публикувана: | 05/14/2020 |
| Действителна начална дата на проучването: | 09/30/2018 |
| Приблизителна дата на първично завършване: | 05/31/2023 |
| Очаквана дата на завършване на проучването: | 05/31/2023 |
Състояние или заболяване
Интервенция / лечение
Drug: Clinical Investigation
Drug: Clinical Investigation
Procedure: Clinical Investigation
Фаза
Групи за ръце
| Arm | Интервенция / лечение |
|---|---|
| Other: Clinical Investigation All participants will undergo GFR (Iohexol Inj 300 MG/ML), ERPF (Aminohippurate Sodium Inj 20%) in addition to renal BOLD and ASL MRI. | Drug: Clinical Investigation Diagnostic aid/agent used to measure effective renal plasma flow (ERPF) |
Критерии за допустимост
| Възрасти, отговарящи на условията за проучване | 12 Years Да се 12 Years |
| Полове, допустими за проучване | All |
| Приема здрави доброволци | Да |
| Критерии | Inclusion Criteria: - Obese youth with and without T2D (≥54 kg) and lean controls - Age 12-21 years - Weight <300 lbs., no implanted metal devices - HbA1c < 11% and no recent diabetic ketoacidosis or hyperosmolar hyperglycemia - No anemia - BMI >5th percentile for lean controls Exclusion Criteria: - T2D onset (diagnosis) > 18 years of age - Prepubertal - eGFR <60ml/min/1.73m2 or creatinine > 1.5mg/dl or history of ACR≥300mg/g - ACE inhibitors, angiotensin receptor blockers (ARB), diuretics, sodium-glucose co-transport (SGLT) 2 or 1 blockers, daily NSAIDs or aspirin, sulfonamides, procaine, thiazosulfone or probenecid. - Seafood or iodine allergy - Pregnancy - MRI scanning contraindications (claustrophobia, implantable devices, >300 lbs) 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 |
Резултат
Първични изходни мерки
1. Effective renal plasma flow (ERPF) [4 hours]
2. Glomerular filtration rate (GFR) [4 hours]
Вторични изходни мерки
1. Insulin sensitivity [4 hours]
2. Renal oxygenation [60 min]
3. Renal perfusion [10 min]
Други изходни мерки
1. Podocyte numerical density and number per glomerulus [4 hours]
2. Foot process width of glomeruli [4 hours]
3. Detachment and endothelial fenestration of glomeruli [4 hours]
4. Podocyte volume of glomeruli [4 hours]
5. Number and identity of RNA in kidney cells [4 hours]
6. Epigenetic profiling [4 hours]
