Mechanisms of Diabetic Nephropathy in Ecuador

NCT02237352 | Suspended DMC

• 1 other identifier: DN-HLV0178-DV
• Study Type: observational
• Target: 10,064
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Diabetic Nephropathy; Diabetes Mellitus; Kidney Diseases; Diabetic Kidney Disease; Chronic Kidney Disease

Keywords

Diabetes mellitus; Diabetic nephropathy; Social Factors; Biological Factors; VEGF-A; Tenascin C; Disease characterization; Mechanisms; Kidney; Chronic kidney disease; Secondary nephropathy; South America; Hispanics; Ecuador; Biomarkers

Outcome Measures

Primary Outcomes (1)

• House localization

  House localization (rural, urban or around the cities) in 2000 persons

  up to 12 month

Secondary Outcomes (1)

• Protein expression

  up to 24 month

Other Outcomes (11)

• Education level

  up 12 month

• Employment

  up to 12 month

• Health insurance coverage

  12 month

Study Arms (2)

Control

Subjects without diabetic nephropathy

Diabetic nephropathy

Subjects with diabetic nephropathy

Eligibility Criteria

• Age: 21 Years - 70 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Community sample (general healthy population and diabetics subjects), and patients with and without diabetic nephropathy evaluated at Hospital Luis Vernaza

You may qualify if:

• 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.

You may not qualify if:

• subjects with acute diseases,
• subjects with not metabolic compensation,
• persons temporarily residing in the place of contact,
• younger than 21 years old,
• older than 70 years old.

Sponsors & Collaborators

• Universidad Estatal de Milagro: lead
• Secretaría de Ciencia, Tecnología e Innovación (Senescyt): collaborator
• PROMETEO: collaborator

Study Sites (1)

UNEMI, Universidad Estatal de Milagro, Facultad de Ciencias de la Salud

Milagro, Guayas, 091050, Ecuador

Location

Biospecimen

Retention: SAMPLES WITHOUT DNA

Plasma and urine.

MeSH Terms

Conditions

Diabetic Nephropathies; Diabetes Mellitus; Kidney Diseases; Renal Insufficiency, Chronic

Condition Hierarchy (Ancestors)

Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases; Diabetes Complications; Endocrine System Diseases; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Renal Insufficiency; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Delma Veron, MD PhD

  Universidad Estatal de Milagro

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: CROSS SECTIONAL
• Target Duration: 1 Day
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 20, 2014
• First Posted: September 11, 2014
• Study Start: September 15, 2014
• Primary Completion: May 1, 2026
• Study Completion: May 1, 2026
• Last Updated: May 5, 2026

Record last verified: 2026-04

Locations

EC (1)