- ICH GCP
- US Clinical Trials Registry
- Klinisk forsøg NCT01371955
Impact of c242T Polymorphism of p22phox in Diabetic type1 Nephropathy (NEPHRODIANOX)
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.
Studieoversigt
Status
Betingelser
Detaljeret beskrivelse
Undersøgelsestype
Tilmelding (Faktiske)
Kontakter og lokationer
Studiesteder
-
-
-
Grenoble, Frankrig, 38043
- University hospital of Grenoble
-
-
Deltagelseskriterier
Berettigelseskriterier
Aldre berettiget til at studere
Tager imod sunde frivillige
Køn, der er berettiget til at studere
Prøveudtagningsmetode
Studiebefolkning
Beskrivelse
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
Studieplan
Hvordan er undersøgelsen tilrettelagt?
Design detaljer
Kohorter og interventioner
Gruppe / kohorte |
---|
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
|
Hvad måler undersøgelsen?
Primære resultatmål
Resultatmål |
Tidsramme |
---|---|
comparison of prevalence of homozygous polymorphism between the DN-group and the non-DN group
Tidsramme: on day 1
|
on day 1
|
Sekundære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
---|---|---|
comparison of polymorphism of p22phox between the ND group and the sub-group of non-ND patients with diabetic retinopathy only
Tidsramme: day 1
|
day 1
|
|
comparison of polymorphism prevalence between the 3 groups
Tidsramme: day 1
|
day 1
|
|
delay between diabetes diagnosis and ND onset by genetic polymorphism
Tidsramme: 20 years
|
Kaplan Meier method
|
20 years
|
Andre resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
---|---|---|
albuminuria
Tidsramme: day 1
|
mg/day
|
day 1
|
HbA1c
Tidsramme: day 1
|
HbA1c in %
|
day 1
|
Samarbejdspartnere og efterforskere
Sponsor
Efterforskere
- Ledende efterforsker: BENHAMOU pierre yves, MD PhD, service de diabétologie
Datoer for undersøgelser
Studer store datoer
Studiestart
Primær færdiggørelse (Faktiske)
Studieafslutning (Faktiske)
Datoer for studieregistrering
Først indsendt
Først indsendt, der opfyldte QC-kriterier
Først opslået (Skøn)
Opdateringer af undersøgelsesjournaler
Sidste opdatering sendt (Skøn)
Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier
Sidst verificeret
Mere information
Begreber relateret til denne undersøgelse
Nøgleord
Yderligere relevante MeSH-vilkår
Andre undersøgelses-id-numre
- 1020
- 2010-A01074-35 (Registry Identifier: ID RCB)
Disse oplysninger blev hentet direkte fra webstedet clinicaltrials.gov uden ændringer. Hvis du har nogen anmodninger om at ændre, fjerne eller opdatere dine undersøgelsesoplysninger, bedes du kontakte register@clinicaltrials.gov. Så snart en ændring er implementeret på clinicaltrials.gov, vil denne også blive opdateret automatisk på vores hjemmeside .
Kliniske forsøg med Diabetisk nefropati
-
Assiut UniversityUkendtom Vitreomacular Interface Abnormalities in Diabetic Retinopathy