Type 2 diabetes vascular disease Diabetes type 2
Conditions
Interventions
Pyridoxamine, a vitamin B6 vitamer (Supersmart, Luxembourg). Placebo, capsule
identical to pyridoxamine but without the active substance (i.e. pyridoxamine)
(Supersmart, Luxembourg).
The daily dosa
Sponsors
Universiteit Maastricht
Eligibility
Age
18 Years to 99 Years
Inclusion criteria
Inclusion criteria: - Age >= 18 years, - Diagnosis of type 2 diabetes, - Generalized microvascular dysfunction, i.e. o eGFR 30-60 mL/min/1.73m2, and/or o Microalbuminuria albumin/creatinine ratio 3-30 mg/mmol, and/or o Retinopathy (not proliferative), and/or o Neuropathy (any).
Exclusion criteria
Exclusion criteria: A potential subject who meets any of the following criteria will be excluded from participation in this study: - Uncontrolled diabetes (i.e., hypoglycaemia >2 times/week and/or unstable HbA1c >9%), - Intraocular pressure >=30 mmHg, - History of glaucoma, - Diagnosis of proliferative diabetic retinopathy, - Diagnosis of diabetic macula edema, - Albumine-creatinine ratio >30 mg/mmol, - eGFR 4 U/day, - Drugs abuse, - Use of systemic glucocorticosteroids, - Higher grade hypertension (> 179 mmHg SBP and/or > 109 mmHg DBP), - Diagnosis of inflammatory disease, - Use of an investigational product within the previous month, - Unstable body weight (no drastic changes in lifestyle before or during the intervention are allowed, this means no weight gain or loss >3 kg in the last two months), - Pregnancy or lactation, - Change in use of oral contraceptives or IUD (12 weeks prior of during the intervention), - 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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The primary study parameter is the central retinal arteriolar diameter (CRAE) as measured with retinal funduscopy. | — |
Secondary
| Measure | Time frame |
|---|---|
| Sensitivity analyses of the primary study parameter are: • Microvascular function measured in the eyes with retinal funduscopy, adaptive optics funduscopy, optical coherence tomography angiography (OCT-A) and dynamic vascular analysis • Microvascular function measured in the skin with laser Doppler flowmetry. • Microvascular function measured as plasma markers of endothelial dysfunction and glycation. • Microvascular function measured in kidneys by urine albumin and estimated glomerular filtration rate. Other study parameters • age, • sex, • alcohol use, • lipid profile, • immunological profile, • baseline fasting glucose, • HbA1c, • glucose metabolism and β-cell function, • AGE measurements in skin and blood plasma, • concentration of MGO, • glyoxal and 3-deoxyglucose in blood plasma, • adipokine and inflammatory marker levels in blood plasma, • markers of dicarbonyl stress and oxidative stress in urine, • hepatic fat content, • blood pressure, • heart rate/ECG, • anthropometric measurements, • medical history, • medication use, and • potential (serious) adverse effects. • For monitoring the compliance, the vitamers pyridoxamine, pyridoxal, pyridoxine, and their phosphorylated derivatives will be measured in plasma by UPLC-MS/MS. | — |
Countries
Netherlands
Contacts
Public ContactMAJ Oeteren
Universiteit Maastricht
Outcome results
None listed