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Impact of c242T Polymorphism of p22phox in Diabetic type1 Nephropathy

NCT ID: NCT01371955

Last Updated: 2013-11-15

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

162 participants

Study Classification

OBSERVATIONAL

Study Start Date

2011-01-31

Study Completion Date

2013-03-31

Brief Summary

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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

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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

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Type 1 Diabetes Mellitus Diabetic Nephropathy

Keywords

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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

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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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.

No interventions assigned to this group

diabetic retinopathy group

patient with diabetic retinopathy defined as showing at least one micro aneurysm on retinography. Without nephropathy defined as above

No interventions assigned to this group

no complication group

patient without diabetic nephropathy or retinopathy

No interventions assigned to this group

Eligibility Criteria

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Inclusion Criteria

* caucasian
* diabetic type 1
* older than 18 years old
* written consent

Exclusion Criteria

* other etiology of diabetic nephropathy
* pregnancy
* other type of diabetes
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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University Hospital, Grenoble

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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BENHAMOU pierre yves, MD PhD

Role: PRINCIPAL_INVESTIGATOR

service de diabétologie

Locations

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University Hospital of Grenoble

Grenoble, , France

Site Status

Countries

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France

Other Identifiers

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2010-A01074-35

Identifier Type: REGISTRY

Identifier Source: secondary_id

1020

Identifier Type: -

Identifier Source: org_study_id