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

NCT07038213 | Enrolling By Invitation

• 1 other identifier: AP25794125
• Study Type: observational
• Target: 100
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Diabetes Mellitus; Diabetic Nephropathy

Keywords

Kidneys; Diabetes; Glycation genes; Kazakhs

Outcome Measures

Primary Outcomes (1)

• glycation genes

  Allele and genotype frequencies

  after completion of the study, on average 2 years

Study Arms (2)

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

glycation genes GENETIC

glycation genes

50 patients with diabetes; 50 patients with diabetes mellitus

beta 2 microglobulin DIAGNOSTIC_TEST

b2m

50 patients with diabetes; 50 patients with diabetes mellitus

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• 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

You may not qualify if:

• өage under 18 and over 65 years
• undiagnosed type 2 diabetes mellitus
• lack of informed consent

Sponsors & Collaborators

• Astana Medical University: lead
• Viamedis LLP: collaborator

Study Sites (1)

AstanaMU

Astana, 010000, Kazakhstan

Location

MeSH Terms

Conditions

Diabetes Mellitus; Diabetic Nephropathies

Condition Hierarchy (Ancestors)

Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases; Kidney Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases; Diabetes Complications

Study Officials

• Murzakhmetova Aigerim Orazbayevna Murzakhmetova Aigerim Orazbayevna, PhD

  Astana Medical University

  STUDY DIRECTOR

Study Design

• Study Type: observational
• Observational Model: OTHER
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 9, 2025
• First Posted: June 26, 2025
• Study Start: July 19, 2025
• Primary Completion (Estimated): December 30, 2026
• Study Completion (Estimated): December 30, 2027
• Last Updated: June 26, 2025

Record last verified: 2025-06

Locations

KA (1)