Clinical Trial: Effect of Pyridoxamine Supplementation on Vascular Function and Insulin Sensitivity

Study Status: Recruiting
Recruit Status: Recruiting
Study Type: Interventional

Official Title: The Effect of Pyridoxamine Supplementation on Vascular Function and Insulin Sensitivity; a Double-blind Randomized Placebo Controlled Trial in Abdominally Obese Subjects.

Brief 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.

Detailed Summary:
Sponsor: Maastricht University Medical Center

Current Primary Outcome:

• Insulin sensitivity [ Time Frame: Difference after 8 weeks of intervention ]
  Assessed by hyperinsulinemic-euglycemic clamp
• Microvascular function [ Time Frame: Difference after 8 weeks of intervention ]
  Assessed by contrast-enhanced ultrasound (CEUS) in skeletal muscle

Original Primary Outcome: Same as current

Current Secondary Outcome:

Original Secondary Outcome:

Information By: Maastricht University Medical Center

Dates:
Date Received: November 2, 2016
Date Started: October 2016
Date Completion:
Last Updated: November 2, 2016
Last Verified: November 2016