NCT07522502

Brief Summary

The goal of this observational study is to better understand how diabetes develops in adults at the time of diagnosis. The study focuses on adults with newly diagnosed diabetes in the Kazakh population. The main questions it aims to answer are:

  • How do insulin resistance and beta-cell function differ between participants?
  • How is the immune system involved at the early stage of diabetes?
  • How are inflammation markers related to metabolic changes? Participants undergo clinical and laboratory assessments at diagnosis. These include:
  • Measurement of body mass index (BMI) and blood glucose control (HbA1c)
  • Assessment of insulin resistance and beta-cell function using HOMA2 indices
  • Measurement of C-peptide levels
  • Testing for islet autoantibodies (GADA, IA-2A, ZnT8A, ICA)
  • Measurement of inflammatory markers, including interleukin-1 beta (IL-1β) and interleukin-1 receptor antagonist (IL-1Ra) This study aims to improve understanding of different forms of adult-onset diabetes and support more personalized approaches to diagnosis and treatment.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
240

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started May 2024

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

May 1, 2024

Completed
8 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2025

Completed
8 months until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2025

Completed
7 months until next milestone

First Submitted

Initial submission to the registry

March 25, 2026

Completed
19 days until next milestone

First Posted

Study publicly available on registry

April 13, 2026

Completed
Last Updated

April 13, 2026

Status Verified

April 1, 2026

Enrollment Period

8 months

First QC Date

March 25, 2026

Last Update Submit

April 7, 2026

Conditions

Diabetes Mellitus, Type 2Autoimmune Diabetes

Keywords

adult-onset diabetesnewly diagnosed diabetesinsulin resistancebeta-cell dysfunctionGADAIA-2AZnT8AICAIL-1 betaIL-1RainflammationcytokinesHOMA2C-peptideKazakhstanautoantibody-positiveautoantibody-negative

Outcome Measures

Primary Outcomes (1)

  • IL-1β / IL-1Ra Ratio

    Assessment of the serum IL-1β/IL-1Ra ratio as a marker of immunoinflammatory balance in adults with newly diagnosed diabetes, with comparison according to islet autoantibody status.

    Baseline

Secondary Outcomes (13)

  • Serum IL-1Ra Level

    Baseline

  • Serum IL-1β Level

    Baseline

  • Basal C-Peptide Level

    Baseline

  • HOMA2-IR

    Baseline

  • HOMA2-%B

    Baseline

  • +8 more secondary outcomes

Study Arms (2)

Islet Autoantibody-Positive Adults With Newly Diagnosed Diabetes

Adults with newly diagnosed diabetes who tested positive for at least one islet autoantibody (GADA, IA-2A, ZnT8A, or ICA). Participants undergo clinical and laboratory assessment at diagnosis, including metabolic parameters (BMI, HbA1c, C-peptide, HOMA2 indices) and inflammatory markers (IL-1β and IL-1Ra).

Islet Autoantibody-Negative Adults With Newly Diagnosed Diabetes

Adults with newly diagnosed diabetes who tested negative for all measured islet autoantibodies (GADA, IA-2A, ZnT8A, and ICA). Participants undergo the same clinical and laboratory assessments as the autoantibody-positive group at diagnosis.

Eligibility Criteria

Age25 Years - 75 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Adults with newly diagnosed diabetes recruited from primary health care settings in the Kazakh population. Participants were assessed at the time of diagnosis using clinical, metabolic, and immunological parameters.

You may qualify if:

  • Adults aged 25 years and older
  • Kazakh population with newly diagnosed diabetes mellitus
  • Diagnosis established in routine clinical practice
  • No prior insulin therapy at the time of enrollment
  • No prior use of glucose-lowering therapy beyond initial management
  • Ability and willingness to provide informed consent

You may not qualify if:

  • Clinical features suggestive of classical type 1 diabetes at presentation
  • History of long-term insulin therapy prior to enrollment
  • Severe acute illness or infection at the time of assessment
  • Pregnancy
  • Incomplete clinical or laboratory data

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

West Kazakhstan Marat Ospanov Medical University

Aktobe, 030019, Kazakhstan

Location

MeSH Terms

Conditions

Diabetes Mellitus, Type 2Diabetes Mellitus, Type 1Insulin ResistanceInflammation

Condition Hierarchy (Ancestors)

Diabetes MellitusGlucose Metabolism DisordersMetabolic DiseasesNutritional and Metabolic DiseasesEndocrine System DiseasesAutoimmune DiseasesImmune System DiseasesHyperinsulinismPathologic ProcessesPathological Conditions, Signs and Symptoms

Study Officials

  • Khatimya Kudabayeva

    West Kazakhstan Marat Ospanov State Medical University

    STUDY DIRECTOR

Study Design

Study Type
observational
Observational Model
CASE ONLY
Time Perspective
CROSS SECTIONAL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
PhD Candidate

Study Record Dates

First Submitted

March 25, 2026

First Posted

April 13, 2026

Study Start

May 1, 2024

Primary Completion

January 1, 2025

Study Completion

September 1, 2025

Last Updated

April 13, 2026

Record last verified: 2026-04

Locations

KA(1)