Impact of c242T Polymorphism of p22phox in Diabetic type1 Nephropathy

Type 1 Diabetes Mellitus Clinical Trial

— NEPHRODIANOX  

Official title:

Impact of c242T Polymorphism of p22phox in the Development of Diabetic Nephropathy,in Caucasian Diabetic Type 1 Patient.

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01371955
• Other study ID #: 1020
• Secondary ID: 2010-A01074-35
• Status: Completed
• Phase: N/A
• First received: June 10, 2011
• Last updated: November 14, 2013
• Start date: January 2011
• Est. completion date: March 2013

Study information

• Verified date: November 2013
• Source: University Hospital, Grenoble
• Contact: n/a
• Is FDA regulated: No
• Health authority: France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)
• Study type: Observational

Clinical 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.

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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 162
• Est. completion date: March 2013
• Est. primary completion date: March 2013
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Study Design

Observational Model: Cohort, Time Perspective: Prospective

Related Conditions & MeSH terms

• Diabetes Mellitus
• Diabetes Mellitus, Type 1
• Diabetic Nephropathies
• Diabetic Nephropathy
• Kidney Diseases
• Type 1 Diabetes Mellitus

Locations

Country	Name	City	State
France	University Hospital of Grenoble	Grenoble

Sponsors (1)

Lead Sponsor	Collaborator
University Hospital, Grenoble

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	albuminuria	mg/day	day 1	No
Other	HbA1c	HbA1c in %	day 1	No
Primary	comparison of prevalence of homozygous polymorphism between the DN-group and the non-DN group		on day 1	No
Secondary	comparison of polymorphism of p22phox between the ND group and the sub-group of non-ND patients with diabetic retinopathy only		day 1	No
Secondary	comparison of polymorphism prevalence between the 3 groups		day 1	No
Secondary	delay between diabetes diagnosis and ND onset by genetic polymorphism	Kaplan Meier method	20 years	No