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

Launched by MAASTRICHT UNIVERSITY MEDICAL CENTER · Apr 16, 2024

Keywords

ClinConnect Summary

This clinical trial is exploring whether taking pyridoxamine, a form of vitamin B6, can help improve blood vessel function in people with type 2 diabetes. Patients with this condition often face complications like eye, kidney, and nerve problems due to issues with their small blood vessels. The study will specifically look at how pyridoxamine might reduce harmful substances in the body that can lead to these complications, potentially benefiting the health of the eyes, kidneys, and skin.

To participate in this study, you must be diagnosed with type 2 diabetes and have some level of microvascular dysfunction, which could include certain kidney issues or early signs of eye problems. However, there are some exclusions, such as having uncontrolled diabetes or specific eye conditions. If you join the trial, you can expect regular check-ups and tests to monitor your health and how your body responds to the pyridoxamine supplementation. This research could provide valuable insights into managing diabetes-related complications and improving overall health.

Gender

ALL

Eligibility 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.