Phase 4 Peripheral Arterial Disease Trial, Recruiting

Written by an AI model from ClinicalTrials.gov eligibility criteria and checked on a sample basis. Please confirm against the original criteria.

Who might be able to join this trial:

• People who have been diagnosed with pre-diabetes, shown by specific blood sugar test results: a HbA1c (average blood sugar level) between 5.7% and 6.4%, or fasting blood sugar readings of 100–125 mg/dL on two separate days, or a blood sugar level of 140–199 mg/dL two hours after drinking a sugary drink during a glucose tolerance test.
• People who have established heart or blood vessel disease in at least one area of the body, such as the heart (e.g., a prior heart attack, heart bypass surgery, stent procedure, or significant artery blockage), the brain (e.g., a prior stroke, certain types of mini-strokes, or significant narrowing of the neck arteries), or the legs/lower body arteries (e.g., prior surgery or procedure for poor blood flow to the limbs, limb amputation due to poor blood flow, or leg pain when walking combined with a specific ankle-to-arm blood pressure ratio result).
• People whose kidneys are working at a sufficient level, based on a blood test result of at least 45 mL/min/1.73 m² (confirm with trial site).
• People who have read, understood, and signed an informed consent form and agreed to follow the study procedures.

Who may not be able to join:

• People who have taken metformin or other diabetes medications within the 12 months before joining the trial (note: use of insulin during a hospital stay, or use of certain other medications such as SGLT2 inhibitors or GLP-1 medications for non-diabetes reasons, may not automatically disqualify someone — confirm with trial site).
• People who have used steroid medications (taken by mouth or injection, affecting the whole body) within the 3 months before joining.
• People whose blood sugar readings between the screening visit and the joining date are above certain levels (fasting blood sugar above 130 mg/dL, any blood sugar reading of 180 mg/dL or above, or a HbA1c of 7.0% or above in the past 12 months).
• People whose most recent blood test shows a total CO2 level below the normal range used by the local laboratory (confirm with trial site).
• People currently taking the medications cimetidine, vandetanib, or any whole-body treatment containing a carbonic anhydrase inhibitor (a type of medication used for various conditions — confirm with trial site if unsure).
• People who have cirrhosis (scarring of the liver), active hepatitis (liver inflammation), or jaundice (yellowing of the skin or eyes) at the time of joining, or whose bilirubin blood test result is more than twice the upper limit of normal.
• People who have engaged in binge or heavy alcohol drinking within the 6 months before joining.
• People with severe anaemia, indicated by a haemoglobin blood test result below 10 g/dL.
• People who have previously had a bad reaction or intolerance to metformin.
• People who have had a heart attack, heart stent or bypass procedure, or stroke within the month before joining.
• People with very high blood pressure at the screening visit (top number 180 mmHg or above, or bottom number 110 mmHg or above).
• People with acute or severely worsening heart failure at the time of joining.
• People whose life expectancy is shorter than the length of the study.
• People who, in the trial team's assessment, are unlikely to be able to follow the study requirements reliably.
• People who have a history of dementia or any condition that affects decision-making ability.
• People who are already taking part in another research study that involves being randomly assigned to a drug or medical device treatment (unless a specific exception has been granted).
• People who are pregnant, planning to become pregnant during the trial, or currently breastfeeding.
• Women who could become pregnant and are not using a highly effective form of contraception.

Important: Always verify eligibility with the trial site directly before applying.