- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00910130
Insulin Resistance And End Stage Renal Disease: The Role Of Retinol Binding Protein 4
May 28, 2009 updated by: IRCCS Policlinico S. Matteo
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.
Study Overview
Status
Unknown
Conditions
Study Type
Observational
Enrollment (Anticipated)
30
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Contact
- Name: Giovanni Piotti, MD
- Phone Number: +390382502590
- Email: gpiotti@yahoo.it
Study Contact Backup
- Name: Teresa Rampino, MD
- Phone Number: +390382503896
- Email: t.rampino@smatteo.pv.it
Study Locations
-
-
-
Pavia, Italy, 27100
- Recruiting
- Giovanni Piotti
-
Contact:
- Giovanni Piotti, MD
- Phone Number: +390382502590
- Email: gpiotti@yahoo.it
-
Contact:
- Teresa Rampino, MD
- Phone Number: +390382503896
- Email: t.rampino@smatteo.pv.it
-
Principal Investigator:
- Giovanni Piotti, MD
-
Sub-Investigator:
- Elisa Gabanti
-
Sub-Investigator:
- Esposito Pasquale, MD
-
Sub-Investigator:
- Marilena Gregorini, MD, PHD
-
Sub-Investigator:
- Giulia Bedino, MD
-
Principal Investigator:
- Francesca Bosio, MD
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years to 70 years (Adult, Older Adult)
Accepts Healthy Volunteers
Yes
Genders Eligible for Study
All
Sampling Method
Non-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"
Description
Inclusion Criteria:
- Hemodialysis for "End Stage Renal Disease group"
- Normal Renal Function for "Control group"
Exclusion Criteria:
- Diabetes
- Malnutrition
- Malignancy
- Acute Infection
- Chronic Active Infection
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
---|
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
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Principal Investigator: Giovanni Piotti, MD, Unit Of Nephrology, Dialysis And Transpantation, IRCCS Fondazione Policlinico San Matteo, Pavia Italy
- Study Director: Teresa Rampino, MD, Unit Of Nephrology, Dialysis And Transpantation, IRCCS Fondazione Policlinico San Matteo, Pavia Italy
- Study Chair: Antonio Dal Canton, MD, Unit Of Nephrology, Dialysis And Transpantation, IRCCS Fondazione Policlinico San Matteo, Pavia Italy
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
General Publications
- 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.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
July 1, 2008
Study Registration Dates
First Submitted
May 28, 2009
First Submitted That Met QC Criteria
May 28, 2009
First Posted (Estimate)
May 29, 2009
Study Record Updates
Last Update Posted (Estimate)
May 29, 2009
Last Update Submitted That Met QC Criteria
May 28, 2009
Last Verified
May 1, 2009
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- RBP4
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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