The effect of pyridoxamine supplementation on microvascular function in type 2 diabetes: a double-blind randomized placebo-controlled cross-over trial

Recruiting

• Conditions: Type 2 diabetes; vascular disease; 10012653; 10047079

• Registration Number: NL-OMON56635
• Lead Sponsor: niversiteit Maastricht

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Last Update Posted: 18 June 2024

Recruitment & Eligibility

• Status: Recruiting
• Sex: Not specified
• Target Recruitment: 40

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

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%),
- 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 (e.g. stroke, coronary artery disease,
congestive heart failure, cardiac shunts, history of cardiac surgery, pulmonary
hypertension, cardiac arrhythmias, family history of ventricular arrhythmias or
sudden cardiac death),
- Alcohol usage >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.

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<p>The primary study parameter is the central retinal arteriolar diameter (CRAE)<br /><br>as measured with retinal funduscopy. </p><br>