Identification of Diabetic Nephropathy Biomarkers Through Transcriptomics

NCT05378282 | Completed DMC

• 1 other identifier: HJM 0513/18-1
• Study Type: observational
• Target: 40
• Locations: 1 country
• Sites: 1

Brief Summary

According to the different epidemiological studies in Mexico the prevalence of diabetic nephropathy is 9.1%-40% in diabetic patients, however the complication is subdiagnosed when we see the numbers of uncontrolled diabetics (75%) and patients that are under continuous screening to prevent complications development (only 12.6% had an annual albuminuria measurement). In addition, Mexican have an increased susceptibility to developing diabetic nephropathy. These data highlight the need to identify new biomarkers that could help us to identify those patients at high risk for developing diabetic nephropathy, in order to take preventing measures to delay the progress of the disease to CKD and improve the quality of the patients. Thus, the comparison of transcriptomic profile between diabetic patients with and without diabetic nephropathy is the first step to characterize this complication. In addition, we will be able to identify diabetic nephropathy biomarkers for development of new diagnostic tools and even to find therapeutic targets in Mexican from Hospital Juárez de México.

Conditions

Type 2 Diabetes; Type 2 Diabetes With Renal Manifestations

Keywords

Type 2 Diabetes; transcriptomics; microalbuminuria; biomarkers

Outcome Measures

Primary Outcomes (1)

• Differential Expression in blood and urine of diabetic patiens with and without diabetic nephropathy assesed by RNA seq

  Different expression of down regulated and upregulated genes in blood and urine between patients with type II diabetes with and without diabetic nephropathy

  through study completion, an average of 1 year

Secondary Outcomes (18)

• Demographic data of participants

  through study completion, an average of 1 year

• Data of pharmacological treatment of participants

  through study completion, an average of 1 year

• Habits data, Smoking

  through study completion, an average of 1 year

• Habits data, Exercise

  through study completion, an average of 1 year

• Habits data, Special Diet

  through study completion, an average of 1 year

Study Arms (2)

Diabetic patients without diabetic nephropathy

i. Patients with ≥ 20 years of T2D evolution with normoalbuminuria ii. Patients without a personal or family history of kidney disease in 1st degree relatives iii. Age ≥ 18 years

Diabetic patients with diabetic nephropathy

i. T2D diagnosed at least 5 years before initiating renal replacement therapy ii. Background or diabetic retinopathy by self-report to ensure that albuminuria was the consequence of diabetic nephropathy rather than a non-diabetic glomerulopathy iii. albuminuria ≥ 300 mg/24 h in at least two out of three sterile urine samples iv. no hematuria or signs (including cellular casts), history or predisposition to other kidney or urinary tract disease. v. Age ≥ 18 years

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Mexican patients with Type 2 Diabetes with or without Diabetic Nephropathy

You may qualify if:

• Patients with ≥ 20 years of T2D evolution with normoalbuminuria
• Patients without a personal or family history of kidney disease in 1st degree relatives Age ≥ 18 years
• T2D diagnosed at least 5 years before initiating renal replacement therapy Background or diabetic retinopathy by self-report to ensure that albuminuria was the consequence of diabetic nephropathy rather than a non-diabetic glomerulopathy albuminuria ≥ 300 mg/24 h in at least two out of three sterile urine samples no hematuria or signs (including cellular casts), history or predisposition to other kidney or urinary tract disease.

You may not qualify if:

• Diabetic patients without diabetic nephropathy
• Patients with type 1 diabetes, gesta- tional diabetes, uncontrollable hypertension, active cancer, heart failure, liver or kidney disease, cotreatment with corticosteroids or estrogens, conditions that can cause hyperglycemia, addiction to alcohol or illegal drugs, and dementia or severe psychiatric disor- ders were not included in this study

Sponsors & Collaborators

• Hospital Juarez de Mexico: lead

Study Sites (1)

Hospital Juárez de México

Mexico City, 07760, Mexico

Location

Related Publications (32)

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  BACKGROUND

Biospecimen

Retention: SAMPLES WITH DNA

RNA from urine and total blood

MeSH Terms

Conditions

Diabetes Mellitus, Type 2

Condition Hierarchy (Ancestors)

Diabetes Mellitus; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: CROSS SECTIONAL
• Sponsor Type: OTHER GOV
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 22, 2022
• First Posted: May 18, 2022
• Study Start: September 3, 2021
• Primary Completion: February 28, 2023
• Study Completion: February 28, 2023
• Last Updated: February 28, 2023

Record last verified: 2023-02

Data Sharing

• IPD Sharing: Will not share

Locations

ME (1)