NCT00910130

Brief Summary

The purpose of this study is to determine whether Retinol binding protein 4 has a role in insulin resistance development in patients suffering from end stage renal disease on hemodialysis.

Trial Health

55
Monitor

Trial Health Score

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

Enrollment
30

participants targeted

Target at below P25 for all trials

Geographic Reach
1 country

1 active site

Status
unknown

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

July 1, 2008

Completed
11 months until next milestone

First Submitted

Initial submission to the registry

May 28, 2009

Completed
1 day until next milestone

First Posted

Study publicly available on registry

May 29, 2009

Completed
Last Updated

May 29, 2009

Status Verified

May 1, 2009

First QC Date

May 28, 2009

Last Update Submit

May 28, 2009

Conditions

Keywords

Retinol Binding Protein 4Insulin ResistanceDiabetesEnd Stage Renal DiseaseDialysisNutrition

Study Arms (2)

End Stage Renal Disease

Patients suffering from End Stage Renal Disease on Hemodialysis, without Diabetes

Control

Healthy people, with normal Renal Function and without Diabetes, matched with "ESRD group" for age, gender, BMI

Eligibility Criteria

Age18 Years - 70 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Ambulatory patients or primary care clinic for "End Stage Renal Disease group;" Blood donors or primary care clinic for "Control group"

You may qualify if:

  • Hemodialysis for "End Stage Renal Disease group"
  • Normal Renal Function for "Control group"

You may not qualify if:

  • Diabetes
  • Malnutrition
  • Malignancy
  • Acute Infection
  • Chronic Active Infection

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Giovanni Piotti

Pavia, 27100, Italy

RECRUITING

Related Publications (2)

  • Yang Q, Graham TE, Mody N, Preitner F, Peroni OD, Zabolotny JM, Kotani K, Quadro L, Kahn BB. Serum retinol binding protein 4 contributes to insulin resistance in obesity and type 2 diabetes. Nature. 2005 Jul 21;436(7049):356-62. doi: 10.1038/nature03711.

  • Graham TE, Yang Q, Bluher M, Hammarstedt A, Ciaraldi TP, Henry RR, Wason CJ, Oberbach A, Jansson PA, Smith U, Kahn BB. Retinol-binding protein 4 and insulin resistance in lean, obese, and diabetic subjects. N Engl J Med. 2006 Jun 15;354(24):2552-63. doi: 10.1056/NEJMoa054862.

Biospecimen

Retention: SAMPLES WITH DNA

Serum Subcutaneous adipose tissue

MeSH Terms

Conditions

Insulin ResistanceDiabetes MellitusKidney Failure, Chronic

Condition Hierarchy (Ancestors)

HyperinsulinismGlucose Metabolism DisordersMetabolic DiseasesNutritional and Metabolic DiseasesEndocrine System DiseasesRenal Insufficiency, ChronicRenal InsufficiencyKidney DiseasesUrologic DiseasesFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesMale Urogenital DiseasesChronic DiseaseDisease AttributesPathologic ProcessesPathological Conditions, Signs and Symptoms

Study Officials

  • Giovanni Piotti, MD

    Unit Of Nephrology, Dialysis And Transpantation, IRCCS Fondazione Policlinico San Matteo, Pavia Italy

    PRINCIPAL INVESTIGATOR
  • Teresa Rampino, MD

    Unit Of Nephrology, Dialysis And Transpantation, IRCCS Fondazione Policlinico San Matteo, Pavia Italy

    STUDY DIRECTOR
  • Antonio Dal Canton, MD

    Unit Of Nephrology, Dialysis And Transpantation, IRCCS Fondazione Policlinico San Matteo, Pavia Italy

    STUDY CHAIR

Central Study Contacts

Giovanni Piotti, MD

CONTACT

Teresa Rampino, MD

CONTACT

Study Design

Study Type
observational
Observational Model
CASE CONTROL
Time Perspective
CROSS SECTIONAL
Sponsor Type
OTHER

Study Record Dates

First Submitted

May 28, 2009

First Posted

May 29, 2009

Study Start

July 1, 2008

Last Updated

May 29, 2009

Record last verified: 2009-05

Locations