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 range18 Years

SexALL

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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.

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