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

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

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.

Conditions6

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