Effectiveness of Trivalent Influenza Vaccine (TIV) in Type 2 Diabetes Mellitus (T2DM) Patients Wi… (NCT06252051) | Clinical Trial Compass
CompletedPhase 4
Effectiveness of Trivalent Influenza Vaccine (TIV) in Type 2 Diabetes Mellitus (T2DM) Patients With and Without Complications of Chronic Kidney Disease (CKD)
Indonesia76 participantsStarted 2021-01-05
Plain-language summary
This study assesses the effectiveness of the seasonal flu vaccine in individuals with Type 2 Diabetes Mellitus (T2DM) with and without Chronic Kidney Disease (CKD), as well as in healthy individuals. Additionally, the study investigates the dynamics of cytokines, specifically IL-2 and IL-6, in the three groups following influenza vaccination. The findings from these studies will contribute to our understanding of the safety and efficacy of the influenza vaccine in T2DM and T2DM-CKD, shedding light on inflammation changes and informing future research on mitigation strategies.
Who can participate
Age range
40 Years – 49 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:
Group 1 (T2DM)
* Individuals with Type 2 Diabetes Mellitus (T2DM)
* Age range: 40-59 years
Group 2 (T2DM-CKD):
* Individuals with Type 2 Diabetes Mellitus (T2DM)
* Age range: 40-59 years
* eGFR (ml/min/1.73 m2) \>15
* eGFR (ml/min/1.73 m2) \<89
* Proteinuria
Group 3 (Healthy Person) :
* Individuals without Type 2 Diabetes Mellitus (T2DM)
* Age range: 40-59 years
Exclusion Criteria:
* Incomplete medical records
* CKD Stage 5
* Currently pregnant
* Currently on long-term steroid use
* Received influenza vaccine in the last year
* Diagnosed with malignancy
* Autoimmune disease
* History of allergy to chicken eggs or vaccine constituents
* High fever, seizures, or acute infection
* History of COVID infection based on PCR testing with the last PCR result negative \<14 days
* History of COVID-19 vaccination \<14 days from the last vaccine administration
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.