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Enrolling by invitationNCT07038213Updated Jun 26, 2025

Study of Genome-associated Mechanisms of Diabetic Nephropathy and Evaluation of Nephroprotective Therapy in Patients With Type 2 Diabetes Mellitus in the Kazakh Population

An observational study in Diabetes Mellitus and Diabetic Nephropathy, sponsored by Astana Medical University. Enrolling by invitation at 1 site in Kazakhstan. Open to participants aged 18 Years to 65 Years. Per ClinicalTrials.gov, last updated 2025-06-26.

Primary conditionDiabetic NephropathiesRegistry: Diabetes MellitusReclassifiedWhy we changed it
Registry
Diabetes Mellitus — the first condition term the registry derived for this study.
ClinicalTrials.gg
Diabetic Nephropathies
Why
  1. The study's listed conditions name Diabetic Nephropathies, a narrower term within Diabetes Mellitus.
Confidence
High: the new condition is named in the study's own listed conditions. Of 351 hand-checked studies reclassified this way, 68% were exactly right and 84% in the right disease family; the registry's first term was right for 5% (measured 2026-10-21). How we classify →
Wrong?
Tell us the study's main condition →

Sponsored by Astana Medical University · Observational

Study type
Observational
Model
Other
Time perspective
Prospective
Enrollment
100
Ages
18 Years to 65 Years
Sex
All
01

Study summary

The incidence of diabetes remains a serious global health issue, demanding close attention and the development of comprehensive strategies for prevention, early diagnosis, and effective treatment . According to the International Diabetes Federation (IDF), in 2021, the number of people with diabetes reached 537 million, and it is projected to rise to 783 million by 2045. In the Asia-Pacific region, the number of people with diabetes has reached approximately 206 million .

One of the most common complications of diabetes is diabetic nephropathy. In developed countries, such as the United States and European nations, diabetic nephropathy is a leading cause of chronic kidney disease, placing a significant burden on the healthcare system.

In light of this, the development of more effective methods for early detection of diabetic nephropathy remains a relevant objective. Current research focuses extensively on identifying kidney biomarkers that can signal early kidney damage in the disease's initial stages. Moreover, in recent years, genome-wide association studies (GWAS) have shown that diabetic nephropathy has a genetic component and that susceptibility may vary among different ethnic groups. This underscores the need to develop personalized treatments that consider patients' genetic characteristics.

In emerging economies, such as Kazakhstan, the issue of diabetic nephropathy is also becoming increasingly relevant. The rise in diabetes cases, especially in urban populations, has led to a growing number of chronic kidney disease cases and associated disabilities. This results in significant economic costs for the healthcare system, as the treatment of end-stage renal disease patients requires considerable resources. In Kazakhstan, a particularly important aspect is the lack of studies focused on the genetic and clinical characteristics of diabetic nephropathy in the local population.

The project is particularly valuable due to its emphasis on the Kazakh population, which is underrepresented in global studies. This focus allows for the identification of risk factors and specific characteristics of diabetic nephropathy unique to this ethnic group. Such an approach will substantially enhance the country's scientific and technical capacity and boost Kazakhstan's competitiveness on the international scientific stage.

Given the above, research into genome-associated mechanisms of diabetic nephropathy and evaluation of the effectiveness of nephroprotective therapy in patients with type 2 diabetes within the Kazakh population represent scientific novelty and practical significance. Such studies will help improve the effectiveness of therapeutic and rehabilitation measures, contribute to identifying genetic variations specific to the Kazakh population, and improve patients' quality of life. This will also have a positive impact on healthcare economics and enhance patients' quality of life, while contributing to the global genetic data regarding the Kazakh population.

Read the detailed description

To achieve the goal of the project, the following tasks were formulated, consisting of a subset of direct sequences designed to consistently lead to results. The study of genome-associated mechanisms of diabetic nephropathy and the evaluation of the effectiveness of nephroprotective therapy in patients with type 2 diabetes mellitus in the Kazakh population may provide new diagnostic opportunities and influence treatment options for patients, and this hypothesis has been tested on five proposed tasks:

  1. Recruiting research participants.

    • Make a list of potential participants
    • Invitation of respondents of Kazakh nationality
    • Obtaining written informed consent. A preliminary list of project participants will be created together with endocrinologists. The invitation will be carried out by dialing through the list of participants. A written agreement will be received after the participants have familiarized themselves with the progress of the study.
  2. Working with respondents.

    • Collecting anamnesis of the disease and life
    • Clinical and diagnostic examination of the study participants. Clinical and diagnostic examinations will be conducted for all participants of the study, as a result of which participants will be selected according to the inclusion and exclusion criteria. As a result, a database of study participants will be created.
  3. Conducting a genetic study and a study of the tubular function of the project participants. Glycation genes will be examined from the venous blood samples of the study participants and markers of tubular function such as beta-2 microglobulin, albumin creatinine ratio and Ngal (neutrophil gelatinase-associated lipocalin) will be studied based on urine analysis.
  4. The analysis of the results obtained and the study of the effectiveness of nephroprotective therapy in dynamics in the studied patients.
  5. Interpretation and publication of the results. Based on the results of this study, articles will be prepared for international peer-reviewed journals (with a non-zero impact factor): at least 2 (two) articles in journals from the first three quartiles by impact factor in the Web of Science database or having a CiteScore percentile in the Scopus database of at least 50.
02

Conditions studied

  • Diabetes Mellitus
  • Diabetic Nephropathy

Browse trials for

Keywords

  • Kidneys
  • Diabetes
  • Glycation genes
  • Kazakhs
03

In context

Diabetic Nephropathies Reclassified

543 studies on the registry are indexed under Diabetic Nephropathies; 110 are open to participants now.

This study's planned enrollment of 100 is below the median of 188 across 138 observational studies indexed under Diabetic Nephropathies.

Browse Diabetic Nephropathies studies →

Lead sponsor

Astana Medical University is the lead sponsor of 16 studies on the registry; 3 are open to participants now.

Compared within Diabetic Nephropathies, this study's primary condition as ClinicalTrials.gg classifies it; the registry's first condition term is Diabetes Mellitus. The counts are of registry records indexed under each term, refreshed daily. How we classify →

04

Who can participate

Ages eligible
18 Years to 65 Years
Sexes eligible
All
Accepts healthy volunteers
No
Sampling method
Probability sample

Study population

All patients will be consulted by a therapist, an endocrinologist, a nephrologist, a collection of complaints, anamnesis of the disease and life, an objective examination of organs and systems will be carried out.

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  • consent of the participant (signing the form);
  • patients with a verified diagnosis of type 2 diabetes mellitus of Kazakh nationality
  • age from 18 years to 65 years

Exclusion criteria

Exclusion Criteria:

өage under 18 and over 65 years

  • undiagnosed type 2 diabetes mellitus
  • lack of
  • pregnancy and lactation at the time of inclusion in the study;
  • oncological disease at the time of inclusion in the study, decompensated concomitant somatic pathology.
Terms in these criteria, in plain language(1)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

Informed consent

Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.

You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.

05

Study design

Observational model
Other
Time perspective
Prospective
Enrollment
100 participants (estimated)
Patient registry
No

Groups and cohorts

  • 50 patients with diabetes

    50 patients with diabetes mellitus having kidney disease

    Genetic: glycation genes · Diagnostic Test: beta 2 microglobulin

  • 50 patients with diabetes mellitus

    50 patients with diabetes mellitus without kidney disease

    Genetic: glycation genes · Diagnostic Test: beta 2 microglobulin

Interventions

  • Geneticglycation genes

    glycation genes

  • Diagnostic testbeta 2 microglobulin

    b2m

06

What researchers measure

Primary outcomes

  1. glycation genes

    Allele and genotype frequencies

    Time frame: after completion of the study, on average 2 years

07

Study locations

1 site
  • AstanaMU
    Astana, 010000, Kazakhstan
08

References and documents

Study documents

PDFs hosted by the registry, ClinicalTrials.gov.

Individual participant data

Plan to share: Undecided

09

Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reachedSimilar studies: half by the dot; the band is the middle halfHalf of similar studies reached it by the dot; the band is the middle half, from a quarter to three quarters

Start is estimated for Jul 2025; primary completion for Dec 2026, 17 months later.

Of 38 observational studies under Diabetic Nephropathies, half reached primary completion within 67 months of starting (the median), counting those still running; a quarter within 25. This study's planned 17 months is below that.

How these figures are worked out, and which studies are left out of them.

Registered
Jun 9, 2025
First posted
Jun 26, 2025
StartEst.
Jul 19, 2025
Primary completionEst.
Dec 30, 2026
CompletionEst.
Dec 30, 2027
Last update
Jun 26, 2025
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Jun 26, 2025, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT07038213
Lead sponsor
Astana Medical University
Collaborators
Viamedis LLP
Responsible party
Sponsor
First posted
Jun 26, 2025
Start date
Jul 19, 2025 (estimated)
Primary completion
Dec 30, 2026 (estimated)
Completion
Dec 30, 2027 (estimated)
Last update
Jun 26, 2025

Study contacts

Murzakhmetova Aigerim Orazbayevna Murzakhmetova Aigerim Orazbayevna, PhD
study director · Astana Medical University

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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No contact was published for this record. The registry link below has the sponsor’s details.

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