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Effect of Metformin Hydrochloride on Inflammation and Aging Biomarkers in Pre‑diabetic Patients

Verified siteRegistered drugNo placebo
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What is this trial about?

A plain-language summary of the goals, design and what participants do

The research focuses on people with pre-diabetes, a condition where blood sugar levels are higher than normal but not high enough to be called diabetes. Participants will receive the oral medication Metformin in a film‑coated tablet form, while a comparable group will receive a placebo. The single aim of the trial is to determine whether Metformin can modify biological signs of inflammation and the aging process that are linked to the activation of the NLRP3 inflammasome, a protein complex that helps trigger inflammatory responses.

During the study, volunteers will attend regular visits over an 18‑month period, beginning with a baseline assessment and followed by follow‑up visits roughly every six months. At each visit, blood samples will be taken to measure levels of several substances that indicate inflammation, such as IL-1β, IL-6, and TNFα, as well as markers of blood vessel health, clotting, oxidative stress, and cellular aging. Simple explanations of these markers will be provided, for example, describing them as signals that the body uses to show whether inflammation or stress is occurring. Additional tests will track changes in weight, blood sugar control, and cholesterol levels. The overall design allows researchers to compare the changes in these measurements between the Metformin group and the placebo group to see if the drug influences the biological processes associated with aging and inflammation.

The research process

The trial runs in 4 steps – from screening to follow-up. Each step says what happens and what the team monitors.

  1. Step 1

    Initial visit and start of medication

    At the first visit after joining the study, a baseline assessment is performed. you will provide a blood sample and have measurements taken for weight, blood sugar, hemoglobin a1c, and cholesterol levels. these values serve as the reference point for the study.

    You will receive metformin tablets, each containing 850 mg of metformin hydrochloride. the instruction is to take three tablets each day by mouth, preferably with meals, for the entire duration of the trial.

  2. Step 2

    First follow-up at 6 months

    Six months after the baseline visit, you will attend a follow-up appointment. another blood sample will be taken to measure the same set of biomarkers that were checked at the start, such as inflammatory markers and indicators of biological aging.

    Your continuation of the daily metformin regimen will be confirmed, and any questions about the medication will be addressed.

  3. Step 3

    Second follow-up at 12 months

    At twelve months, a second follow-up visit occurs. a further blood sample is collected to evaluate changes in the previously measured biomarkers.

    The same dosage of metformin (three 850 mg tablets daily) is continued unless a safety concern arises.

  4. Step 4

    Final visit at 18 months and end of study

    The last visit takes place eighteen months after the baseline. a final blood sample is drawn to assess the long‑term effect of the treatment on the selected biomarkers.

    After this visit, the daily metformin medication is stopped, and the study concludes for you.

Who can join the trial?

5 criteria

  • Be an adult (male or female) aged between 18 and 60 years.
  • Have a body mass index (BMI) between 18 and 35 kg/m² (BMI measures weight relative to height).
  • If you are in the pre‑diabetic group (study arms A & B), you must meet at least one of these lab results: a fasting blood sugar (called basal glycaemia) measured twice and ranging from 110 to 125 mg/dL; or a 2‑hour blood sugar of 140 to 199 mg/dL after a 75‑gram oral glucose tolerance test; or an HbA1c level between 5.7% and 6.4% (HbA1c shows average blood sugar over the past 2‑3 months).
  • If you are a healthy control (study arm C), your fasting blood sugar must be less than 110 mg/dL and your HbA1c must be less than 5.7%.
  • Healthy controls must not have other cardiovascular risk factors: your blood pressure must be lower than 130/80 mmHg and your total cholesterol must be below 240 mg/dL (with LDL‑c, the “bad” cholesterol, below 160 mg/dL).

Who cannot join the trial?

8 criteria

  • Not willing or able to follow all scheduled visits, treatment plan, laboratory tests, lifestyle changes, or any other study procedures.
  • Currently receiving medical care for any health condition other than pre‑diabetes, or regularly taking medication for any condition, including diabetes medicines.
  • Has a known history of drug or substance abuse (using illegal drugs or misusing prescription drugs).
  • Is an active smoker or a former smoker who stopped smoking less than 12 months before screening.
  • Has any other health problem that the investigator believes could affect the study results.
  • Has any condition or situation that would make it difficult to follow the study rules.
  • Is a woman who could become pregnant (women of childbearing potential) and plans to become pregnant during the 18‑month study period.
  • Is currently enrolled in another clinical trial or has participated in one within the three months before this study.
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Investigated drugs

Metformin is an oral medication that helps lower blood sugar levels. In this study, it is given to people who have pre‑diabetes to see if it can change specific signs of inflammation and cell aging in the body. Researchers will compare the blood test results of participants taking metformin with those of participants who are not receiving any medication, to understand how metformin may affect the processes linked to “inflammageing” and the NLRP3 inflammasome.

What is already known about the treatment

Metformin - Metformin is taken by mouth as a film‑coated tablet; it is an approved, widely used drug that appears in standard medical literature. It is mainly prescribed to lower blood sugar in type 2 diabetes and is also used in pre‑diabetic patients to help keep glucose levels normal. It works by reducing the amount of sugar the liver releases and by improving how the body uses insulin. It is classified as a biguanide oral hypoglycemic agent.

Investigated diseases

Pre-diabetes - Pre-diabetes is a condition where blood sugar levels are higher than normal but not high enough for a diabetes diagnosis. It develops when the body’s ability to use insulin begins to decline or when the pancreas does not produce enough insulin. Over time, glucose control can worsen, leading to type 2 diabetes if lifestyle factors are not addressed. The condition is often identified by elevated fasting glucose, impaired glucose tolerance, or increased HbA1c. It may be accompanied by early changes in metabolism and inflammation. Monitoring helps track its progression.
Trial detailsLast updated 2 Oct 2026
Age18+ yearsPhasePhase IIITrial ID2026-527080-15-00Estimated enrolment105 patients

sourced from the EU Clinical Trials Register and site verification

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