At a glance
ClinicalIndex Comparison RecordStandardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
Sex-related Differences in Arterial Stiffness in Type 2 Diabetics: Role of Uric Acid
In Brief
A Phase 2 clinical trial evaluating Low-fructose diet, isocaloric, Allopurinol, and 2 other interventions for Diabetes Mellitus, Type 2 and Hyperuricemia. Completed, enrolled 34 participants across 1 site.
Detailed 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.
Study Details
Timeline
Interventions
6 month of consumption a low fructose diet
6 months of allopurinol treatment with the goal of decreasing uric acid compared to control group
6 months of placebo treatment
6 month of consumption a low fructose diet with a 500 Calorie/day energy restriction