Diabetes MellitusNCT07038213
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 of Diabetes Mellitus and Diabetic Nephropathy, run by Astana Medical University at 1 site in Kazakhstan.
Trial 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 . Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Diabetes Mellitus, Diabetic Nephropathy
- What is being tested?
- glycation genes and beta 2 microglobulin
- How many people
- 100 participants
- Where
- 1 siteKazakhstan
- Study dates
- 19 Jul 2025to 30 Dec 2027
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
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.
Who may be able to join
- consent of the participant (signing the informed consent form);
- patients with a verified diagnosis of type 2 diabetes mellitus of Kazakh nationality
- age from 18 years to 65 years
Who cannot join
- өage under 18 and over 65 years
- undiagnosed type 2 diabetes mellitus
- lack of informed consent
- 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.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
About this study
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.
Read more
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:
- 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.
- 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.
- 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.
- The analysis of the results obtained and the study of the effectiveness of nephroprotective therapy in dynamics in the studied patients.
- 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.
- Conditions
- Diabetes Mellitus, Diabetic Nephropathy
- Being tested
- glycation genes, beta 2 microglobulin
- Keywords
- Kidneys, Diabetes, Glycation genes, Kazakhs
- Medical subject headings
- Diabetes Mellitus, Diabetic Nephropathies
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
glycation genesGenetic
glycation genes
beta 2 microglobulinDiagnostic test
b2m
| Study group | Role | What they receive |
|---|---|---|
| 50 patients with diabetes | 50 patients with diabetes mellitus having kidney disease Receives: Genetic: glycation genes; Diagnostic Test: beta 2 microglobulin | |
| 50 patients with diabetes mellitus | 50 patients with diabetes mellitus without kidney disease Receives: Genetic: glycation genes; Diagnostic Test: beta 2 microglobulin |
What is being measured
The primary outcome is the main question the study is designed to answer.
glycation genes
Allele and genotype frequencies
Measured: after completion of the study, on average 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Jun 2025
- Study start19 Jul 2025 (estimated)
- Primary completion30 Dec 2026 (estimated)
- Study completion30 Dec 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Diabetes MellitusStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Other
- Time perspective
- Prospective
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Astana Medical University
- Sponsor type
- University, hospital or other
- Collaborators
- Viamedis LLP
- Responsible party
- Sponsor
- Investigators
- Murzakhmetova Aigerim Orazbayevna Murzakhmetova Aigerim Orazbayevna, PhD, Study director, Astana Medical University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07038213
- Sponsor's protocol ID
- AP25794125
- Status last verified
- Jun 2025
- First submitted
- 9 Jun 2025
- Last updated
- 26 Jun 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 26 Jun 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Study of Genome-associated Mechanisms of Diabetic Nephropathy and Evaluation of Nephroprotective Therapy in Patients With Type 2 Diabetes Mellitus in the Kazakh Population
- ClinicalTrials.gov ID
- NCT07038213
- Acronym / sponsor ID
- AP25794125
- Conditions
- Diabetes Mellitus, Diabetic Nephropathy
- Keywords
- Kidneys, Diabetes, Glycation genes, Kazakhs
- Study type
- Observational
- Recruitment status
- Enrolling by invitation
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Astana Medical UniversityUniversity, hospital or other
- Collaborators
- Viamedis LLP
- Study start
- 19 Jul 2025 (estimated)
- Primary completion
- 30 Dec 2026 (estimated)
- Study completion
- 30 Dec 2027 (estimated)
- First posted
- 26 Jun 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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:
- 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.
- 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.
- 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.
- The analysis of the results obtained and the study of the effectiveness of nephroprotective therapy in dynamics in the studied patients.
- 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.
Study design
- Observational model
- Other
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 50 patients with diabetes | – | Genetic: glycation genes, Diagnostic Test: beta 2 microglobulin50 patients with diabetes mellitus having kidney disease |
| 50 patients with diabetes mellitus | – | Genetic: glycation genes, Diagnostic Test: beta 2 microglobulin50 patients with diabetes mellitus without kidney disease |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (3 listed)
- consent of the participant (signing the informed consent form);
- patients with a verified diagnosis of type 2 diabetes mellitus of Kazakh nationality
- age from 18 years to 65 years
Key exclusion criteria (5 listed)
- өage under 18 and over 65 years
- undiagnosed type 2 diabetes mellitus
- lack of informed consent
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| glycation genesglycation genes | Genetic | 50 patients with diabetes, 50 patients with diabetes mellitus |
| beta 2 microglobulinb2m | Diagnostic test | 50 patients with diabetes, 50 patients with diabetes mellitus |
Primary outcome
glycation genes
Time frame: after completion of the study, on average 2 years
Allele and genotype frequencies
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Jun 2025.
- Individual participant dataSharing planned: Undecided
Related trials for Diabetes Mellitus
Not yet recruitingPhase 3
Efficacy and Safety of Once-Weekly SHR-3167 Compared With Once-Daily Insulin Glargine in Adults With Insulin-Naive Type 2 Diabetes
Type 2 Diabetes
Active, not recruiting
Digital Reinforcement of Motivational Interviewing Micro-Skills Among Primary Care Healthcare Professionals
Hypertension (Without Type 2 Diabetes Mellitus)
Recruiting
Effects of Lean Pork Loin Intake on Protein Homeostasis and Glucose Regulation in Prediabetic Adults
Hyperglycaemia (Non Diabetic), Prediabetes
Recruiting
PAW-Hydrogel for Chronic Wound Healing
Diabetic Foot Ulcer (DFU), Pressure Ulcer (PU)
Recruiting
Investigating Vascular Properties of HEMI and SPG Signals in Individuals With or at Risk for Chronic Kidney Disease
Chronic Kidney Disease, Hypertension (HTN)
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Murzakhmetova Aigerim Orazbayevna Murzakhmetova Aigerim Orazbayevna, PhD study director
Astana Medical University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Diabetes Mellitus and Diabetic Nephropathy, run by Astana Medical University at 1 site in Kazakhstan.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: enrolling by invitation, as of the sponsor's last update on 26 Jun 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Kazakhstan. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
glycation genes (time frame: after completion of the study, on average 2 years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 26 Jun 2025.