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NCT02237352Suspended

Mechanisms of Diabetic Nephropathy in Ecuador

Physiopathogenic Mechanisms Involved in Diabetic Nephropathy, Looking for Prevention and Treatment Solutions

Source: ClinicalTrials.gov · Last updated 5 May 2026

Reason given: economic supports no granted

Brief summary (registry, in English)

The prevalence of diabetes mellitus (DM) is increasing worldwide, suggesting that 45% of diabetics are undiagnosed. DM induces a kidney disease called diabetic nephropathy (DN) which is the largest single cause of end-stage renal disease and dialysis requirement. In South America the prevalence of DM and chronic kidney disease has increased, and great disparity exists among countries in regards to access to the dialysis treatment. It has been considerate that Hispanic origin increases the risk for DM. The South Americans have distinctive habits, culture, environment, behavior and genetic background and the factors involved in DN have not been defined yet. The early kidney lesions such as neoangiogenesis (pathologic generation of the new blood vessels) and extracellular matrix expansion have been described. The vascular endothelial growth factor A (VEGF) has been linked to angiogenesis, but the role of VEGF in DN has not been elucidated yet. VEGF signals mainly through VEGF receptor 2 (VEGFR2). VEGFR2 interacts with alphaV beta3 integrin (AVB3) in kidney. Additionally tenascin C is expressed in the extracellular matrix. Tenascin C and the tenascin C/AVB3 complex have also been linked to angiogenesis, however their roles have not been unveiled yet in the DN. Investigators hypothesize that VEGF signaling and tenascin C play an important role in DN and that VEGFR2, AVB3 and tenascin C interact. The purposes of this study is to characterize social, environmental and biological factors implicated in the DN in Ecuador and define the role of VEGF signaling and tenascin C in the pathogenesis of the DN. Investigators propose to study factors involved in DN in diabetic and non-diabetic adults from general population, with and without DN. In a single time investigators will evaluate demographics data, habits, personal and family history through a survey. Investigators will measure anthropometrics parameters and blood pressure; investigators will quantify blood glucose, glycosylated hemoglobin A1c and proteinuria. In addition investigators will examine the role of tenascin C and VEGF signaling by analyzing paraffin embedded kidney tissue, plasma and urine samples. Characterizing the factors involved in the DN from Hispanic people is key to establish adequate strategies of prevention, diagnosis and treatment in this population. Furthermore elucidating the role of proteins involved in DN may offer valuable tools for the development of new treatments.

Status (registry)
Suspended
Study type
Observational
Enrollment
10064 (actual)
First submitted
20 Aug 2014
Start date
15 Sept 2014
Primary completion date
1 May 2026
Lead sponsor
Universidad Estatal de Milagro
NCT number
NCT02237352

Who cannot take part

Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.

Other illness

  • subjects with acute diseases,

Age

  • younger than 21 years old,
  • older than 70 years old.

Other

  • subjects with not metabolic compensation,
  • persons temporarily residing in the place of contact,

Who the study is looking for

  • adults,
  • age between 21 and 70 years old,
  • persons able to sign informed consent,
  • diabetics without diabetic nephropathy,
  • diabetic with diabetic nephropathy,
  • not hospitalized,
  • not suffering acute disease,
  • living in their home for at least 6 months before to be contacted.

Age in the registry: 21 years to 70 years · Sex: All · Accepts healthy volunteers

Full criteria on ClinicalTrials.gov

Sites (1)

Sites in registry order. Save your city in your profile to sort them by distance.

SiteCityCountrySite status
UNEMI, Universidad Estatal de Milagro, Facultad de Ciencias de la SaludMilagroEcuadorUnknown status

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