NCT06376240Completed
The Effect of Pyridoxamine Supplementation on Microvascular Function in Type 2 Diabetes
The Effect of Pyridoxamine Supplementation on Microvascular Function in Type 2 Diabetes: a Double-blind Randomized Placebo-controlled Crossover Trial
Source: ClinicalTrials.gov · Last updated 27 Apr 2026
Brief summary (registry, in English)
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.
- Status (registry)
- Completed
- Study type
- Interventional
- Enrollment
- 40 (actual)
- First submitted
- 8 Apr 2024
- Start date
- 21 Mar 2024
- Primary completion date
- 13 Mar 2026
- Lead sponsor
- Maastricht University Medical Center
- Diseases
- Chronic kidney disease, Type 2 diabetes
- NCT number
- NCT06376240
What you commit to
- Study type: Interventional
- Participants enrolled: 40
- From 21 Mar 2024 to the primary completion date, 13 Mar 2026
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Drugs abuse,
- Use of an investigational product within the previous month,
- 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,
Other illness
- History of glaucoma,
- Diagnosis of epilepsy,
- Active cardiovascular disease,
- Higher grade hypertension
- Diagnosis of inflammatory disease,
Lab values
- Uncontrolled diabetes (i.e., hypoglycaemia \>2 times/week and/or unstable HbA1c \>9%),
- Albumine-creatinine ratio \>30 mg/mmol,
- eGFR \<30 mL/min/1.73m2,
Other
- Use of \>12 Units long-acting insulin per day,
- Use of short-acting insulin,
- Intraocular pressure ≥30 mmHg,
- Diagnosis of proliferative diabetic retinopathy,
- Diagnosis of diabetic macula edema,
- Alcohol usage \>4 U/day,
- Use of systemic glucocorticosteroids,
- Unstable body weight,
- Pregnancy or lactation,
- Change in use of oral contraceptives or IUD,
- Insufficient knowledge of the Dutch language,
- Inability to provide written informed consent.
Who the study is looking for
- 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).
Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Academic Hospital Maastricht Coordinator of this site? Confirm its status | Maastricht | Netherlands | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.