PErfusioN, OxyGen ConsUmptIon and ENergetics in ADPKD (PENGUIN)
Keywords
Abstract
Dates
Last Verified: | 04/30/2020 |
First Submitted: | 05/18/2020 |
Estimated Enrollment Submitted: | 05/26/2020 |
First Posted: | 05/28/2020 |
Last Update Submitted: | 05/26/2020 |
Last Update Posted: | 05/28/2020 |
Actual Study Start Date: | 06/30/2020 |
Estimated Primary Completion Date: | 06/29/2022 |
Estimated Study Completion Date: | 12/30/2022 |
Condition or disease
Intervention/treatment
Drug: Adults with autosomal dominant polycystic kidney disease
Drug: Adults with autosomal dominant polycystic kidney disease
Radiation: Adults with autosomal dominant polycystic kidney disease
Phase
Arm Groups
Arm | Intervention/treatment |
---|---|
Adults with autosomal dominant polycystic kidney disease All participants will undergo DXA scan, PET/CT using 11-C acetate to measure renal oxygen consumption, hyperinsulinemic-euglycemic clamp to quantify insulin sensitivity, and renal clearance testing using iohexol and para-aminohippurate (PAH) to quantify glomerular filtration rate (GFR) and effective renal plasma flow (ERPF). | Drug: Adults with autosomal dominant polycystic kidney disease Diagnostic aid/agent used to measure effective renal plasma flow (ERPF) |
Healthy Controls Comparative data will be provided from healthy adults from an ongoing study with similar study design and methods (CROCODILE Study: Control of Renal Oxygen Consumption, Mitochondrial Dysfunction, and Insulin Resistance). |
Eligibility Criteria
Ages Eligible for Study | 18 Years To 18 Years |
Sexes Eligible for Study | All |
Sampling method | Probability Sample |
Accepts Healthy Volunteers | Yes |
Criteria | Inclusion Criteria: - Patients with Autosomal dominant polycystic kidney disease - Age 18-40 years - BMI >= 18.5 and <30 kg/m2 - Weight <350 lbs Exclusion Criteria: - Diabetes mellitus, based on previous diagnosis - Albuminuria (≥30mg/g) or estimated glomerular filtration rate (eGFR) <75ml/min/1.73m2 - Pregnancy or nursing - Anemia - Allergy to shellfish or iodine - Vaptan therapy (e.g. tolvaptan) - Uncontrolled hypertension (average ≥140/90 mmHg) |
Outcome
Primary Outcome Measures
1. Renal oxygen consumption [30 minutes]
2. Insulin Sensitivity [4.5 hours]
Secondary Outcome Measures
1. Mitochondrial Function [5 minutes]
2. Mitochondrial Function [5 minutes]
3. Mitochondrial Function [5 minutes]
4. Mitochondrial Function [5 minutes]
5. Glomerular Filtration Rate (GFR) [3 hours]
6. Effective Renal Plasma Flow (ERPF) [2.5 hours]
7. Renin-Angiotensin-Aldosterone-System Activity [5 minutes]
8. Renin-Angiotensin-Aldosterone-System Activity [5 minutes]
9. Renin-Angiotensin-Aldosterone-System Activity [5 minutes]
10. Kidney Injury Biomarkers [5 minutes]
11. Kidney Injury Biomarkers [5 minutes]
12. Kidney Injury Biomarkers [5 minutes]
13. Kidney Injury Biomarkers [5 minutes]
14. Kidney Injury Biomarkers [5 minutes]
15. Kidney Injury Biomarkers [5 minutes]