CompletedNot Applicable

Identification of Diabetic Nephropathy Biomarkers Through Transcriptomics

Mexico40 participantsStarted 2021-09-03

Plain-language 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.

Who can participate

Age range

18 Years – 65 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion Criteria: * 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. Exclusion Criteria: * 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

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

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

Timeframe: through study completion, an average of 1 year

Trial details

NCT IDNCT05378282

SponsorHospital Juarez de Mexico

Sponsor typeOTHER_GOV

Study typeOBSERVATIONAL

Primary completion2023-02-28

View on ClinicalTrials.gov More Type 2 Diabetes trials