Last updated on May 2019

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

Brief description of study

Two 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). At the beginning and end of both 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.

Detailed Study Description

Sedentary, overweight and obese subjects diagnosed with T2D, age > 55 years old, will be recruited from the local community, via the University of Missouri's Endocrinology Clinic and the primary care clinics. During screening, and after consent, anthropometrics (waist circumference and body composition) will be obtained and fasting blood will be drawn for serum chemistries, A1c, complete blood count, liver and kidney function. Subjects in the fructose restriction arm will alcohol restrictions with the dietitian, and will be given a chance to acclimate to the hooded mode of the metabolic cart to prepare for future energy-expenditure measurements. Following screening, eligible subjects will be assigned to one of the three groups (allopurinol, placebo or fructose restriction). Allopurinol will be titrated to achieve a target dose of 300 mg/day. Along with placebo, this arm of the study is double-blinded. A separate group of men and women will be assigned to the fructose-restriction study in which dietary fructose is replaced by starch and body weight is held constant. The subjects in this group will not be blinded to the dietary treatment but the staff making measurements will be. Subjects in the three groups will be matched for age and BMI.

Clinical Study Identifier: NCT03648996

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University of Missouri

Columbia, MO United States
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