NCT01589705

Brief Summary

There are substantial data demonstrating increased endothelial dysfunction, inflammation and oxidative stress in patients with Autosomal dominant polycystic kidney disease (ADPKD), the association between serum uric acid level and endothelial dysfunction has not been elucidated yet in these patients. Therefore, in this study, the investigators aimed to examine the relationship between the uric acid level and the ED in normotensive ADPKD patients with preserved renal function.

Trial Health

57
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
150

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Jan 2012

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
terminated

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2012

Completed
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 1, 2012

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

April 1, 2012

Completed
29 days until next milestone

First Submitted

Initial submission to the registry

April 30, 2012

Completed
2 days until next milestone

First Posted

Study publicly available on registry

May 2, 2012

Completed
Last Updated

July 31, 2012

Status Verified

July 1, 2012

Enrollment Period

3 months

First QC Date

April 30, 2012

Last Update Submit

July 29, 2012

Conditions

Keywords

Uric acidpolycystic kidney disease

Outcome Measures

Primary Outcomes (1)

  • Measurement of asymmetric dimethylarginine (ADMA) and flow mediated dilatation (FMD)

    ADMA,FMD and uric acid measurements were performed to determine endothelial dysfunction in ADPKD patients

    4 months

Study Arms (1)

polycystic kidney ,no hypertension

The study evaluated the association of serum uric acid levels with endothelial dysfunction in early ADPKD patients with normal renal function

Eligibility Criteria

Age20 Years - 60 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64)
Sampling MethodNon-Probability Sample
Study Population

Patients with early stage(preserved renal function) Autosomal dominant polycystic kidney disease (n = 91) from two academic medical center.We also excluded the patients with a previous diagnosis of hypertension, gout, diabetes, current use of oral antidiabetic medication, insulin, thiazide, allopurinol or uricosuric, or a fasting glucose level 126 mg/dl. In addition, the subjects with a history of smoking or current use of any anti-hypertensive medication and statins were excluded

You may qualify if:

  • ADPKD patients with normal renal function,
  • Normotensive ADPKD patients

You may not qualify if:

  • Patients with impaired kidney function,
  • Atherosclerotic disorders,
  • Diagnosis of hypertension, gout, diabetes,
  • Using of insulin, thiazide, allopurinol or uricosuric drugs

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Erciyes University Medical School

Kayseri, 38039, Turkey (Türkiye)

Location

Related Publications (1)

  • Kocyigit I, Yilmaz MI, Orscelik O, Sipahioglu MH, Unal A, Eroglu E, Kalay N, Tokgoz B, Axelsson J, Oymak O. Serum uric acid levels and endothelial dysfunction in patients with autosomal dominant polycystic kidney disease. Nephron Clin Pract. 2013;123(3-4):157-64. doi: 10.1159/000353730. Epub 2013 Jul 25.

MeSH Terms

Conditions

Polycystic Kidney, Autosomal DominantPolycystic Kidney Diseases

Condition Hierarchy (Ancestors)

Kidney Diseases, CysticKidney DiseasesUrologic DiseasesFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesMale Urogenital DiseasesAbnormalities, MultipleCongenital AbnormalitiesCongenital, Hereditary, and Neonatal Diseases and AbnormalitiesCiliopathiesGenetic Diseases, Inborn

Study Officials

  • Bulent Tokgoz, Professor

    Erciyes University Medical School

    STUDY DIRECTOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
CROSS SECTIONAL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
TC Erciyes University Medical School

Study Record Dates

First Submitted

April 30, 2012

First Posted

May 2, 2012

Study Start

January 1, 2012

Primary Completion

April 1, 2012

Study Completion

April 1, 2012

Last Updated

July 31, 2012

Record last verified: 2012-07

Locations