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NCT Number: NCT01371955

Impact of c242T Polymorphism of p22phox in Diabetic type1 Nephropathy

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.

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Key information

Conditions

Type 1 Diabetes Mellitus Autoimmune Diseases Diabetes Complications Diabetes Mellitus Diabetes Mellitus, Type 1 Diabetic Nephropathies Diabetic Nephropathy Endocrine System Diseases Female Urogenital Diseases Female Urogenital Diseases and Pregnancy Complications Glucose Metabolism Disorders Granulomatous Disease, Chronic, Autosomal Recessive, Cytochrome B-Negative Immune System Diseases Kidney Diseases Male Urogenital Diseases Metabolic Diseases Nutritional and Metabolic Diseases Urogenital Diseases Urologic Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

University Hospital of Grenoble

Grenoble, 38043, France

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Primary outcomes

  1. comparison of prevalence of homozygous polymorphism between the DN-group and the non-DN group

    Time frame: on day 1

Secondary outcomes

  1. 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

  2. comparison of polymorphism prevalence between the 3 groups

    Time frame: day 1

  3. delay between diabetes diagnosis and ND onset by genetic polymorphism

    Time frame: 20 years

    Kaplan Meier method

Other outcomes

  1. albuminuria

    Time frame: day 1

    mg/day

  2. HbA1c

    Time frame: day 1

    HbA1c in %

Sponsors and collaborators

Lead sponsor

University Hospital, Grenoble

Other

Registry information

Official study title

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

Acronym: NEPHRODIANOX

Important dates

Study start
2011
Primary completion
2013
Study completion
2013
First posted
Jun 13, 2011
Registry last updated
Nov 15, 2013

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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