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

NCT06376240 | Completed

• 1 other identifier: NL85203.068.23
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Type 2 Diabetes; Microvascular Function; Retinopathy, Diabetic; Nephropathy, Diabetic; Neuropathy, Diabetic

Keywords

Pyridoxamine; Advanced Glycation End Products; Methylglyoxal; Type 2 Diabetes

Outcome Measures

Primary Outcomes (1)

• Central retinal artery equivalent of the eye

  in μm, measured with funduscopy

  8 weeks

Other Outcomes (13)

• eGFR

  8 weeks

• Microvascular function in skin

  8 weeks

• Markers of endothelial function and glycation in blood plasma.

  8 weeks

Study Arms (2)

Treatment order AB

EXPERIMENTAL

Treatment with A (either pyridoxamine or placebo) in period 1 followed by treatment with B (either pyridoxamine or placebo) in period 2.

Dietary Supplement: Pyridoxamine 300mg per day; Other: Placebo 300mg placebo per day

Treatment order BA

EXPERIMENTAL

Treatment with B (either pyridoxamine or placebo) in period 1 followed by treatment with A (either pyridoxamine or placebo) in period 2.

Dietary Supplement: Pyridoxamine 300mg per day; Other: Placebo 300mg placebo per day

Interventions

Pyridoxamine 300mg per day DIETARY_SUPPLEMENT

oral supplement

Treatment order AB; Treatment order BA

Placebo 300mg placebo per day OTHER

oral supplement

Treatment order AB; Treatment order BA

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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).

You may not qualify if:

• 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

Sponsors & Collaborators

• Maastricht University Medical Center: lead
• Diabetes Fonds: collaborator

Study Sites (1)

Academic Hospital Maastricht

Maastricht, 6229 HX, Netherlands

Location

MeSH Terms

Conditions

Diabetes Mellitus, Type 2; Diabetic Retinopathy; Diabetic Nephropathies; Diabetic Neuropathies

Interventions

Pyridoxamine

Condition Hierarchy (Ancestors)

Diabetes Mellitus; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases; Retinal Diseases; Eye Diseases; Diabetic Angiopathies; Vascular Diseases; Cardiovascular Diseases; Diabetes Complications; Kidney Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases; Peripheral Nervous System Diseases; Neuromuscular Diseases; Nervous System Diseases

Intervention Hierarchy (Ancestors)

Vitamin B 6; Picolines; Pyridines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 8, 2024
• First Posted: April 19, 2024
• Study Start: March 21, 2024
• Primary Completion: March 13, 2026
• Study Completion: March 13, 2026
• Last Updated: April 27, 2026

Record last verified: 2026-04

Locations

NL (1)