The Effect of Pyridoxamine Supplementation on Microvascular Function in Type 2 Diabetes: a Double-blind Randomized Placebo-controlled Crossover Trial

Status: Recruiting
Location: See location...
Intervention Type: Other, Dietary supplement
Study Type: Interventional
Study Phase: Not Applicable
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.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: f
View:

• 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).

Locations
Other Locations
Netherlands
Academic Hospital Maastricht
RECRUITING
Maastricht
Contact Information
Primary
M. van Oeteren, MD
intmed-onderzoek@maastrichtuniversity.nl
+31883887628
Time Frame
Start Date: 2024-03-21
Estimated Completion Date: 2025-12-31
Participants
Target number of participants: 40
Treatments
Experimental: Treatment order AB
Treatment with A (either pyridoxamine or placebo) in period 1 followed by treatment with B (either pyridoxamine or placebo) in period 2.
Experimental: Treatment order BA
Treatment with B (either pyridoxamine or placebo) in period 1 followed by treatment with A (either pyridoxamine or placebo) in period 2.
Sponsors
Collaborators: Diabetes Fonds
Leads: Maastricht University Medical Center

This content was sourced from clinicaltrials.gov