Effect of Pyridoxamine Supplementation on Vascular Function and Insulin Sensitivity
Effect of Pyridoxamine Supplementation on Vascular Function and Insulin Sensitivity
NCT ID: NCT02954588 Phase: NA Status: COMPLETED Enrollment: 112 Completion: 2020-08-08
Conditions
Abdominal Obesity Metabolic Syndrome
Interventions
Pyridoxamine, Placebo
Summary
A growing body of evidence demonstrates that increased adipose mass, especially visceral adipose tissue, contributes directly towards an increase in systemic inflammation, (micro-)vascular dysfunction and the burden of cardiovascular disease (CVD), insulin resistance and type 2 diabetes. Advanced glycation/lipoxidation endproducts (AGEs/ALEs) are a heterogeneous family of unavoidable by-products, which are formed by reactive metabolic intermediates derived from glucose and lipid oxidation. In addition to the overwhelming amount of data demonstrating the role of AGEs/ALEs in the development of (micro-)vascular dysfunction and disease, accumulation of AGEs/ALEs in the expanding adipose tissue contributes to the dysregulation of adipokines and the development of insulin resistance.
The investigators want to examine, in a double-blind randomized placebo controlled parallel study, the physiological effect of a dietary intervention with pyridoxamine in abdominally obese persons.
A sub-study is implemented next to the clinical trial. The objective of the sub-study is to measure the metabolization and kinetics of pyridoxamine in plasma and urine with UPLC-MS/MS. The sub-study comprises of 5 additional healthy volunteers, with pyridoxamine as an oral supplement.
Primary Outcome
Insulin sensitivity