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

• Status: Recruiting
• Trial end date: 2022-09-30
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: University of Missouri-Columbia
• Treatments: Allopurinol; Uric Acid

Criteria

Inclusion Criteria:

• Men and women ages 40-75 years at randomization

• BMI between 25.1 and 50 kg/m2.

• Type 2 diabetes diagnosed > 3 months ago. Patients with T2D will be classified based on physician diagnosis.

Exclusion Criteria:

• serum uric acid < 5.5 mg/dL (for medication/allopurinol and isocaloric low-fructose diet arm)

• habitual diet containing low amount of sugars < 5% of total energy intake

• recent CVD event (stroke, heart failure hospitalization, revascularization or acute coronary event in the last 12 months).

• abnormal thyroid tests or chronic liver disease

• stage IV renal disease (GFR <30)

• hyperparathyroidism

• use of azathioprine

• active cancer

• autoimmune diseases

• excessive alcohol consumption (>14 drinks/week for men, >7 drinks/week for women)

• current tobacco use

• bodyweight change ≥10% within the last 6 months

• history of gout or uncontrolled hypertension

• A1C >10 % (only for medication/placebo arm)

• Pregnancy or lactation in women (or women not using contraceptives)