Study on the Effect of Metformin on Inflammation and Biological Ageing in People with Prediabetes.
EU CTIS ID: 2026-527080-15-00
What this study is testing
To assess changes in biomarkers of NLRP3 inflammasome activation and resulting end-product in pre-diabetic patients treated with metformin compared to those not receiving treatment.
- Therapeutic use (Phase IV)
A plain-language read of the study's public EU CTIS listing. The study team confirms the details.
Who can take part
You may be able to join if
- Arms A & B: Prediabetic subjects - Adults, male and female, aged 18-60 - Must present at least one criteria of pre-diabetes: basal glycaemia of 110-125 mg/dL measured twice or 140-199 mg/dL after 2h of glucose tolerance test (75 g), or HbA1c between 5.7-6.4%. - BMI between 18-35 kg/m2
- Arm C: Healthy controls - Adults, male and female, aged 18-60 - BMI between 18-35 kg/m2 - Basal glycaemia <110mg/dL and HbA1c <5.7% - Absence of other CV risk factors at screening, defined as high blood pressure (BP ≥ 130/80 mmHg) and high blood cholesterol (total cholesterol ≥ 240 mg/dL or LDL-c ≥ 160).
You likely can't join if
- Participants are not willing or able to comply with: all scheduled visits, treatment plan, laboratory tests, lifestyle considerations, or other study procedures.
- Participants who are currently under medical follow-up for any medical condition (besides prediabetes for Arms A & B) or who are regularly taking medication for any condition, including any diabetic treatment.
- Have a known history of drug substance abuse.
- Active smokers or former smokers who quit less than 12 months prior to screening.
- Any other condition that, in the opinion if the Investigator, may interfere with the outcome evaluation of the trial.
- Any condition or situation precluding or interfering with the compliance with the protocol.
See the full eligibility criteria
- Arms A & B: Prediabetic subjects - Adults, male and female, aged 18-60 - Must present at least one criteria of pre-diabetes: basal glycaemia of 110-125 mg/dL measured twice or 140-199 mg/dL after 2h of glucose tolerance test (75 g), or HbA1c between 5.7-6.4%. - BMI between 18-35 kg/m2
- Arm C: Healthy controls - Adults, male and female, aged 18-60 - BMI between 18-35 kg/m2 - Basal glycaemia <110mg/dL and HbA1c <5.7% - Absence of other CV risk factors at screening, defined as high blood pressure (BP ≥ 130/80 mmHg) and high blood cholesterol (total cholesterol ≥ 240 mg/dL or LDL-c ≥ 160).
- Participants are not willing or able to comply with: all scheduled visits, treatment plan, laboratory tests, lifestyle considerations, or other study procedures.
- Participants who are currently under medical follow-up for any medical condition (besides prediabetes for Arms A & B) or who are regularly taking medication for any condition, including any diabetic treatment.
- Have a known history of drug substance abuse.
- Active smokers or former smokers who quit less than 12 months prior to screening.
- Any other condition that, in the opinion if the Investigator, may interfere with the outcome evaluation of the trial.
- Any condition or situation precluding or interfering with the compliance with the protocol.
- Women of childbearing potential (WOCBP) who plan to become pregnant during the 18-month study period.
- Participant is currently enrolled or has enrolled in a clinical trial three months prior to inclusion in the current study.
The study team makes the final eligibility decision.
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18-64 years. The study team makes the final eligibility decision.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from EU CTIS; the study team decides eligibility.