Pyridoxamine supplementation to improve blood vessel 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
This study is testing if taking a daily supplement of pyridoxamine can help improve blood vessel function in people with type 2 diabetes.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 40 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Maastricht University Medical Center Academic / other |
| Locations | 1 site (Maastricht) |
| Trial ID | NCT06376240 on ClinicalTrials.gov |
What this trial studies
This study investigates the effects of pyridoxamine, a form of vitamin B6, on microvascular function in patients with type 2 diabetes. It aims to determine whether daily supplementation with 300mg of pyridoxamine can reduce the harmful effects of methylglyoxal, a by-product of glucose metabolism that contributes to vascular complications. The study will assess improvements in microvascular function in the eye, kidney, and skin, as well as reductions in markers of endothelial dysfunction and glycation. Participants will be compared to a placebo group receiving an equivalent dose of a placebo.
Who should consider this trial
Good fit: Ideal candidates are individuals diagnosed with type 2 diabetes who exhibit signs of microvascular dysfunction.
Not a fit: Patients with uncontrolled diabetes or severe complications such as proliferative diabetic retinopathy may not benefit from this study.
Why it matters
Potential benefit: If successful, this treatment could significantly improve vascular health and reduce complications associated with type 2 diabetes.
How similar studies have performed: Previous studies have shown promising results with similar approaches targeting methylglyoxal and microvascular function, suggesting potential for success.
Eligibility criteria
Show full inclusion / exclusion criteria
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.
Where this trial is running
Maastricht
- Academic Hospital Maastricht — Maastricht, Netherlands (Recruiting)
Study contacts
- Study coordinator: M. van Oeteren, MD
- Email: intmed-onderzoek@maastrichtuniversity.nl
- Phone: +31883887628
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.