PErfusioN, OxyGen ConsUmptIon and ENergetics in ADPKD (PENGUIN)

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Brief Title

PErfusioN, OxyGen ConsUmptIon and ENergetics in ADPKD (PENGUIN)

Official Title

PENGUIN: PErfusioN, OxyGen ConsUmptIon and ENergetics in ADPKD

Brief Summary

      Autosomal dominant polycystic kidney disease (ADPKD) is the most common monogenic cause of
      end-stage kidney disease (ESKD). The disorder is characterized by development and continued
      growth of multiple cysts requiring renal replacement therapy in 50% of patients by age 60
      years. However, ADPKD is also a complex metabolic disorder defined by insulin resistance (IR)
      and mitochondrial dysfunction which may be causally related to cyst expansion, kidney
      function decline and contribute to reduced life expectancy. Renal hypoxia, stemming from a
      potential metabolic mismatch between increased renal energy expenditure and impaired
      substrate utilization, is proposed as a novel unifying early pathway in the development and
      expansion of renal cysts in ADPKD. By examining the interplay between renal O2 consumption
      and energy utilization in young adults with and without ADPKD, the investigators hope to
      identify novel therapeutic targets to impede development of cyst expansion in future trials.

      The investigators propose to address the specific aims in a cross-sectional study with 20
      adults with ADPKD (50% female, ages 18-40 years). 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). For
      this protocol, participants will complete a one day study visit at Children's Hospital
      Colorado. Patients will undergo a dual energy x-ray absorptiometry (DXA) to assess body
      composition, and a 11C-acetate positron emission tomography (PET/CT) scan to quantify renal
      O2 consumption. After the PET/CT, participants will undergo a hyperinsulinemic-euglycemic
      clamp while fasting to quantify insulin sensitivity. Glomerular Filtration Rate (GFR) and
      Effective Renal Plasma Flow (ERPF) will be measured by iohexol and PAH clearances during the
      hyperinsulinemic-euglycemic clamp.
    



Study Type

Observational


Primary Outcome

Renal oxygen consumption

Secondary Outcome

 Mitochondrial Function

Condition

Polycystic Kidney Disease, Adult

Intervention

Aminohippurate Sodium Inj 20%

Study Arms / Comparison Groups

 Adults with autosomal dominant polycystic kidney disease
Description:  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).

Publications

* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information


Recruitment Status

Drug

Estimated Enrollment

20

Start Date

November 1, 2020

Completion Date

December 31, 2023

Primary Completion Date

June 30, 2023

Eligibility 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)
      

Gender

All

Ages

18 Years - 40 Years

Accepts Healthy Volunteers

No

Contacts

, 720-777-6148, [email protected]

Location Countries

United States

Location Countries

United States

Administrative Informations


NCT ID

NCT04407481

Organization ID

20-0277


Responsible Party

Principal Investigator

Study Sponsor

University of Colorado Denver School of Medicine Barbara Davis Center


Study Sponsor

, , 


Verification Date

August 2021