Phase 2
Completed N=34
Sex-related Differences in Arterial Stiffness in Type 2 Diabetics: Role of Uric Acid
Source: ClinicalTrials.gov NCT03648996 ↗Enrolled (actual)
34
Serious AEs
3.6%
Results posted
Jul 2023
Primary outcomePrimary: Carotid Femoral Pulse Wave Velocity (cfPWV) — 8.71; 7.8; 8.28 m/s
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.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Carotid Femoral Pulse Wave Velocity (cfPWV) |
8.71; 7.8; 8.28 | — |
| SECONDARY Brachial Artery Flow Mediated Dilation (FMD) |
5.03; 4.4; 7.10 | — |
| SECONDARY Insulin-stimulated Leg Blood Flow |
-7.68; 68.18; 42.65 | — |
Eligibility 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 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)
Data sourced from ClinicalTrials.gov (NCT03648996). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.