CompletedNot Applicable

The Effect of Pyridoxamine Supplementation on Microvascular Function in Type 2 Diabetes

Netherlands40 participantsStarted 2024-03-21

Plain-language summary

Patients with type 2 diabetes have an increased risk of developing vascular complications. Microvascular dysfunction might be caused by the increased production of methylglyoxal under hyperglycaemic conditions. Methylglyoxal is a by-product of glycolysis and forms advanced glycation endproducts (AGEs) on proteins and DNA, thereby disrupting their function. Preventing methylglyoxal accumulation and AGEs formation may offer a therapeutic option for treating microvascular complications in diabetics. Pyridoxamine is a vitamin B6 vitamer that scavenges methylglyoxal and thereby inhibits the formation of AGEs. In this study, the researchers investigate whether pyridoxamine supplementation in type 2 diabetes improves microvascular function in the eye, kidney and skin, and reduces markers of endothelial dysfunction and glycation.

Who can participate

Age range

18 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: * Diagnosis of type 2 diabetes, * Generalized microvascular dysfunction, i.e. * eGFR 30-60 mL/min/1.73m2, and/or * Microalbuminuria albumin-creatinine ratio 3-30 mg/mmol, and/or * Retinopathy (not proliferative), and/or * Neuropathy (any). Exclusion Criteria: * Uncontrolled diabetes (i.e., hypoglycaemia \>2 times/week and/or unstable HbA1c \>9%), * Use of \>12 Units long-acting insulin per day, * Use of short-acting insulin, * Intraocular pressure ≥30 mmHg, * History of glaucoma, * Diagnosis of proliferative diabetic retinopathy, * Diagnosis of diabetic macula edema, * Albumine-creatinine ratio \>30 mg/mmol, * eGFR \<30 mL/min/1.73m2, * Diagnosis of epilepsy, * Active cardiovascular disease, * Alcohol usage \>4 U/day, * Drugs abuse, * Use of systemic glucocorticosteroids, * Higher grade hypertension * Diagnosis of inflammatory disease, * Use of an investigational product within the previous month, * Unstable body weight, * Pregnancy or lactation, * Change in use of oral contraceptives or IUD, * Unwillingness to give up being a blood donor (or having donated blood) from 8 weeks prior to the start of the study to end of study, * Insufficient knowledge of the Dutch language, * Inability to provide written informed consent.

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

Central retinal artery equivalent of the eye

Timeframe: 8 weeks

Trial details

NCT IDNCT06376240

SponsorMaastricht University Medical Center

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2026-03-13

View on ClinicalTrials.gov More Type 2 Diabetes trials