Metabolic and Immunoinflammatory Profiles in Adults With Newly Diagnosed Diabetes (NCT07522502) | Clinical Trial Compass
CompletedNot Applicable
Metabolic and Immunoinflammatory Profiles in Adults With Newly Diagnosed Diabetes
Kazakhstan240 participantsStarted 2024-05-01
Plain-language 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.
Who can participate
Age range
25 Years – 75 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:
* 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
Exclusion Criteria:
* 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
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
1
IL-1β / IL-1Ra Ratio
Timeframe: Baseline
Trial details
NCT IDNCT07522502
SponsorWest Kazakhstan Marat Ospanov Medical University