Type 1 Diabetes MellitusNEPHRODIANOXNCT01371955
Impact of c242T Polymorphism of p22phox in Diabetic type1 Nephropathy
An observational study of Type 1 Diabetes Mellitus and Diabetic Nephropathy, run by University Hospital, Grenoble at 1 site in France.
Trial summary
The physiopathology of diabetic nephropathy (DN) is unclear. To investigate risk factor, the investigators choose to look about some oxidative stress genes. Today a one-gene explanation is not really possible. So the theory of some genetic predisposition to DN is more likely. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Type 1 Diabetes Mellitus, Diabetic Nephropathy
- How many people
- 162 participants
- Where
- 1 siteFrance
- Study dates
- Jan 2011to Mar 2013
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: caucasian diabetic type 1 patients with more than 20 years of diabetes duration
Who may be able to join
- caucasian
- diabetic type 1
- older than 18 years old
- written consent
Who cannot join
- other etiology of diabetic nephropathy
- pregnancy
- other type of diabetes
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Impact of c242T Polymorphism of p22phox in the Development of Diabetic Nephropathy,in Caucasian Diabetic Type 1 Patient.
The physiopathology of diabetic nephropathy (DN) is unclear. To investigate risk factor, the investigators choose to look about some oxidative stress genes. Today a one-gene explanation is not really possible. So the theory of some genetic predisposition to DN is more likely.
The aim of the study is to look about the association of the C282T polymorphism of P22phox, a sub unit of the nicotinamide adenine dinucleotide phosphate-oxidase (NADPH oxidase) in the occurrence of DN. To follow the oxidative stress pathway of the DN, the investigators also investigate three other polymorphisms: -429 T/C, -374 T/A polymorphism of advanced glycation end-products receptor (AGER) and the p.Arg261Gln polymorphism of the 12 lipoxygenase (ALOX 12). Discordant data suggest a link between the first 2 polymorphisms and DN. The last polymorphism is correlated to albuminuria in diabetic patients.
Read the detailed description
To avoid confounding factors, we choose type 1 diabetic patients. We plan, with the data of literature a number need to be significative with a power of 80% and an Alpha risk at 5%, the inclusion of 160 patients for our primary analyze of p 22 phox. Those patients are included consequentially from the diabetic consultation of the university hospital of Grenoble, if they have a history of more than 20 years of diabetes. Those patients have been separated according to the existence of DN, and their polymorphism. Then we estimate with the Fisher test the prevalence of DN in risky patient, and the prevalence of the risky phenotype in the nephropathic patients. Then we investigate with the same statistical test the -429 T/C,he -374 T/A AGER and p.Arg261Gln 12 ALOX polymorphisms.
- Conditions
- Type 1 Diabetes Mellitus, Diabetic Nephropathy
- Keywords
- diabetic nephropathy, CYBA, p22phox, RAGE, 12LOX, genetic, Type 1 Diabetes Mellitus with Diabetic Dermatitis, caucasian, more than twenty years of diabetes duration, older than 18 years, no nephropathy other than diabetic nephropathy
- Medical subject headings
- Diabetes Mellitus, Type 1, Diabetic Nephropathies, Granulomatous Disease, Chronic, Autosomal Recessive, Cytochrome B-Negative
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 |
|---|---|---|
| diabetic nephropathy group | patient with diabetic nephropathy, defined as Albuminuria > 30 mg/day or urinary Albumine/ creatinine ratio > 3 mg/mmol ; or GFR estimated by MDRD less than 60 ml/min.1,73m². With no other etiology of diabetic nephropathy. | |
| diabetic retinopathy group | patient with diabetic retinopathy defined as showing at least one micro aneurysm on retinography. Without nephropathy defined as above | |
| no complication group | patient without diabetic nephropathy or retinopathy |
What is being measured
The primary outcome is the main question the study is designed to answer.
comparison of prevalence of homozygous polymorphism between the DN-group and the non-DN group
Measured: on day 1
Secondary outcomes (3)
comparison of polymorphism of p22phox between the ND group and the sub-group of non-ND patients with diabetic retinopathy only
Measured: day 1
comparison of polymorphism prevalence between the 3 groups
Measured: day 1
delay between diabetes diagnosis and ND onset by genetic polymorphism
Kaplan Meier method
Measured: 20 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Jun 2011 (estimated)
- Study startJan 2011
- Primary completionMar 2013
- Study completionMar 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Type 1 Diabetes MellitusStudies of the same condition, open and under way.
- More trials run by University Hospital, GrenobleThe 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
- Cohort
- Time perspective
- Prospective
- Enrolment
- 162 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital, Grenoble
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- BENHAMOU pierre yves, MD PhD, Principal investigator, service de diabétologie
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01371955
- Sponsor's protocol ID
- 1020
- Other IDs
- 2010-A01074-35
- Acronym
- NEPHRODIANOX
- Status last verified
- Nov 2013
- First submitted
- 10 Jun 2011
- Last updated
- 15 Nov 2013
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 15 Nov 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Impact of c242T Polymorphism of p22phox in the Development of Diabetic Nephropathy,in Caucasian Diabetic Type 1 Patient.
- ClinicalTrials.gov ID
- NCT01371955
- Acronym / sponsor ID
- NEPHRODIANOX / 1020
- Conditions
- Type 1 Diabetes Mellitus, Diabetic Nephropathy
- Keywords
- diabetic nephropathy, CYBA, p22phox, RAGE, 12LOX, genetic, Type 1 Diabetes Mellitus with Diabetic Dermatitis, caucasian
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 162 participants (actual)
- Lead sponsor
- University Hospital, GrenobleUniversity, hospital or other
- Study start
- Jan 2011
- Primary completion
- Mar 2013 (actual)
- Study completion
- Mar 2013 (actual)
- First posted
- 13 Jun 2011 (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 physiopathology of diabetic nephropathy (DN) is unclear. To investigate risk factor, the investigators choose to look about some oxidative stress genes. Today a one-gene explanation is not really possible. So the theory of some genetic predisposition to DN is more likely.
The aim of the study is to look about the association of the C282T polymorphism of P22phox, a sub unit of the nicotinamide adenine dinucleotide phosphate-oxidase (NADPH oxidase) in the occurrence of DN. To follow the oxidative stress pathway of the DN, the investigators also investigate three other polymorphisms: -429 T/C, -374 T/A polymorphism of advanced glycation end-products receptor (AGER) and the p.Arg261Gln polymorphism of the 12 lipoxygenase (ALOX 12). Discordant data suggest a link between the first 2 polymorphisms and DN. The last polymorphism is correlated to albuminuria in diabetic patients.
Detailed description
To avoid confounding factors, we choose type 1 diabetic patients. We plan, with the data of literature a number need to be significative with a power of 80% and an Alpha risk at 5%, the inclusion of 160 patients for our primary analyze of p 22 phox. Those patients are included consequentially from the diabetic consultation of the university hospital of Grenoble, if they have a history of more than 20 years of diabetes. Those patients have been separated according to the existence of DN, and their polymorphism. Then we estimate with the Fisher test the prevalence of DN in risky patient, and the prevalence of the risky phenotype in the nephropathic patients. Then we investigate with the same statistical test the -429 T/C,he -374 T/A AGER and p.Arg261Gln 12 ALOX polymorphisms.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| diabetic nephropathy group | – | –patient with diabetic nephropathy, defined as Albuminuria > 30 mg/day or urinary Albumine/ creatinine ratio > 3 mg/mmol ; or GFR estimated by MDRD less than 60 ml/min.1,73m². With no other etiology of diabetic nephropathy. |
| diabetic retinopathy group | – | –patient with diabetic retinopathy defined as showing at least one micro aneurysm on retinography. Without nephropathy defined as above |
| no complication group | – | –patient without diabetic nephropathy or retinopathy |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- caucasian diabetic type 1 patients with more than 20 years of diabetes duration
Key inclusion criteria (4 listed)
- caucasian
- diabetic type 1
- older than 18 years old
- written consent
Key exclusion criteria (3 listed)
- other etiology of diabetic nephropathy
- pregnancy
- other type of diabetes
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
comparison of prevalence of homozygous polymorphism between the DN-group and the non-DN group
Time frame: on day 1
3 secondary outcomes
comparison of polymorphism of p22phox between the ND group and the sub-group of non-ND patients with diabetic retinopathy only
Time frame: day 1
comparison of polymorphism prevalence between the 3 groups
Time frame: day 1
delay between diabetes diagnosis and ND onset by genetic polymorphism
Time frame: 20 years
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Nov 2013.
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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.
BENHAMOU pierre yves, MD PhD principal investigator
service de diabétologie
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 Type 1 Diabetes Mellitus and Diabetic Nephropathy, run by University Hospital, Grenoble at 1 site in France.
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 4 inclusion and 3 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: finished, as of the sponsor's last update on 15 Nov 2013. 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 France. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
comparison of prevalence of homozygous polymorphism between the DN-group and the non-DN group (time frame: on day 1). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 15 Nov 2013.