drugset / Trial / NCT03648996

Sex-related Differences in Arterial Stiffness in Type 2 Diabetics: Role of Uric Acid

NCT03648996

Phase 2 Completed 34 enrolled University of Missouri-Columbia
RandomizedParallel-groupTriple-blindTreatment

Summary

Three separate interventions will be undertaken with the primary outcome of improving pulse wave velocity. Initially, age and BMI-matched men and post-menopausal women, all with type 2 diabetes, will be treated with allopurinol (20 men, 20 women) for 6 months, in order to reduce serum uric acid (SUA) concentrations relative to placebo (10 men, 10 women). In a second intervention, dietary fructose will be restricted for a period of 6 months in type 2 diabetes (T2D) subjects who will maintain a stable weight (20 men, 20 women). In a third intervention, dietary fructose will be restricted for a period of 6 months in type 2 diabetes (T2D) subjects who will achieve a caloric deficit and weight reduction (20 men, 20 women). At the beginning and end of each of the studies, measures of arterial stiffness will be combined with assessments of endothelial function (flow-mediated dilation and insulin stimulated leg blood flow), measurements of systemic inflammation and oxidative stress.

Timeline

Start
2018-11-01
Primary completion
2022-03-10
Completion
2022-03-10

Drugs

EvaluationDrugModalityDoseRoute
Subject Allopurinol Small molecule 300 mg