Insulin ResistanceNCT00910130
Insulin Resistance And End Stage Renal Disease: The Role Of Retinol Binding Protein 4
An observational study of Insulin Resistance and Diabetes, run by Fondazione IRCCS Policlinico San Matteo di Pavia at 1 site in Italy.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 70 yearsHealthy volunteers can take part
- Conditions the study is for
- Insulin Resistance, Diabetes, End Stage Renal Disease
- How many people
- 30 participants
- Where
- 1 siteItaly
- Study dates
- Jul 2008to not given
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 70 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: Ambulatory patients or primary care clinic for "End Stage Renal Disease group;" Blood donors or primary care clinic for "Control group"
Who may be able to join
- Hemodialysis for "End Stage Renal Disease group"
- Normal Renal Function for "Control group"
Who cannot join
- Diabetes
- Malnutrition
- Malignancy
- Acute Infection
- Chronic Active Infection
Trial locations and contacts
1 site in 1 country.
Italy1 site, 1 recruiting
- Recruiting
Giovanni Piotti
Pavia, 27100
Giovanni Piotti, MD, +390382502590, gpiotti@yahoo.it
Teresa Rampino, MD, +390382503896, t.rampino@smatteo.pv.it
About this study
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.
- Conditions
- Insulin Resistance, Diabetes, End Stage Renal Disease
- Keywords
- Retinol Binding Protein 4, Insulin Resistance, Diabetes, End Stage Renal Disease, Dialysis, Nutrition
- Medical subject headings
- Insulin Resistance, Diabetes Mellitus, Kidney Failure, Chronic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| 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 |
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 May 2009 (estimated)
- Study startJul 2008
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Insulin ResistanceStudies of the same condition, open and under way.
- More trials run by Fondazione IRCCS Policlinico San Matteo di PaviaThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case-control
- Time perspective
- Cross-sectional
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Fondazione IRCCS Policlinico San Matteo di Pavia
- Sponsor type
- University, hospital or other
- Investigators
- Giovanni Piotti, MD, Principal investigator, Unit Of Nephrology, Dialysis And Transpantation, IRCCS Fondazione Policlinico San Matteo, Pavia ItalyTeresa Rampino, MD, Study director, Unit Of Nephrology, Dialysis And Transpantation, IRCCS Fondazione Policlinico San Matteo, Pavia ItalyAntonio Dal Canton, MD, Study chair, Unit Of Nephrology, Dialysis And Transpantation, IRCCS Fondazione Policlinico San Matteo, Pavia Italy
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00910130
- Sponsor's protocol ID
- RBP4
- Status last verified
- May 2009
- First submitted
- 28 May 2009
- Last updated
- 29 May 2009
- Results posted
- No
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.
PubMed 16034410Graham 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.
PubMed 16775236
Study at a glance
From the registry record, last updated by the sponsor on 29 May 2009. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Insulin Resistance And End Stage Renal Disease: The Role Of Retinol Binding Protein 4
- ClinicalTrials.gov ID
- NCT00910130
- Acronym / sponsor ID
- RBP4
- Conditions
- Insulin Resistance, Diabetes, End Stage Renal Disease
- Keywords
- Retinol Binding Protein 4, Insulin Resistance, Diabetes, End Stage Renal Disease, Dialysis, Nutrition
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- Fondazione IRCCS Policlinico San Matteo di PaviaUniversity, hospital or other
- Study start
- Jul 2008
- First posted
- 29 May 2009 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Case-control
- Time perspective
- Cross-sectional
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 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 |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Ambulatory patients or primary care clinic for "End Stage Renal Disease group;" Blood donors or primary care clinic for "Control group"
Key inclusion criteria (2 listed)
- Hemodialysis for "End Stage Renal Disease group"
- Normal Renal Function for "Control group"
Key exclusion criteria (5 listed)
- Diabetes
- Malnutrition
- Malignancy
- Acute Infection
- Chronic Active Infection
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Not reported in the source record.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 May 2009.
- Results publication: PubMed 16034410Yang 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.
- Results publication: PubMed 16775236Graham 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Giovanni Piotti, MD principal investigator
Unit Of Nephrology, Dialysis And Transpantation, IRCCS Fondazione Policlinico San Matteo, Pavia Italy
Teresa Rampino, MD study director
Unit Of Nephrology, Dialysis And Transpantation, IRCCS Fondazione Policlinico San Matteo, Pavia Italy
Antonio Dal Canton, MD study chair
Unit Of Nephrology, Dialysis And Transpantation, IRCCS Fondazione Policlinico San Matteo, Pavia Italy
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Insulin Resistance and Diabetes, run by Fondazione IRCCS Policlinico San Matteo di Pavia at 1 site in Italy.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 29 May 2009. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Italy. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Giovanni Piotti, MD (+390382502590, gpiotti@yahoo.it), or a site near the patient. AzTrials does not enrol participants or take referrals.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00910130, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 29 May 2009.