Impact of c242T Polymorphism of p22phox in Diabetic type1 Nephropathy

Completed

• Conditions: Type 1 Diabetes Mellitus; Diabetic Nephropathy

• Registration Number: NCT01371955
• Lead Sponsor: University Hospital, Grenoble

Brief 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.

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 Timeline

• Study Start: 2011-01
• Study First Submitted: 2011-06-10
• Study First Submitted QC: 2011-06-10
• Study First Posted: 2011-06-13
• Primary Completion: 2013-03
• Study Completion: 2013-03
• Status Verified: 2013-11
• Last Update Submitted: 2013-11-14
• Last Update Posted: 2013-11-15

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 162

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

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
comparison of prevalence of homozygous polymorphism between the DN-group and the non-DN group	on day 1

Secondary Outcome Measures

Name	Time	Method
comparison of polymorphism of p22phox between the ND group and the sub-group of non-ND patients with diabetic retinopathy only	day 1
delay between diabetes diagnosis and ND onset by genetic polymorphism	20 years	Kaplan Meier method
comparison of polymorphism prevalence between the 3 groups	day 1

Trial Locations

Locations (1)

University Hospital of Grenoble; 🇫🇷 Grenoble, France