NCT03076684

Gender Differences in the Metabolic Effects of Uric Acid

• Status: Withdrawn
• Phase: EARLY_Phase 1
• Study type: Interventional
• Enrollment: 0 (actual)
• Sponsor: University of Missouri-Columbia · Academic / Other
• Sex: All
• Age: 40 Years – 70 Years
• Healthy volunteers: Accepted

Summary

Increased stiffening of the heart and blood vessels is a predictor of heart disease. Stiffening has been found to be greater in women than men, which puts women with poor blood sugar control at a greater risk for heart disease than men. In women only, a molecule in the blood called uric acid can be elevated due to diets high in fructose consumption and it is thought to be a cause of heart and vessel stiffening. From previous research, we have found that restricting fructose in the diet lowers uric acid more in women than men. There is also a drug that can be used to lower uric acid. These findings suggest a potential approach to decrease vessel and heart stiffness in women. The present study will investigate fructose restriction in the diet and drug treatment to lower uric acid in the blood and its effects on heart disease risk in women compared to men.

Detailed description

This project will use treatments from 4-8 months to lower uric acid in men and women. This study has three parts and each subject will participate in only one part. Tests that will be performed before and after treatment include measurements of body weight, blood pressure, blood vessel stiffness, heart stiffness, and blood lipids and glucose. Part 1: Dietary treatment The overall goal of part 1 is to remove fructose and simple sugars from the diets of women and men at risk for future heart disease. Dietary fructose will be replaced with starchy foods to keep the research subjects' body weights stable. Subjects will be treated for 4 months and measurements of vascular and heart stiffness will be made before, during, and after treatment. Part 2: Drug treatment The overall goal of part 2 is to treat women and men with mild elevations in blood uric acid for 8 months. The treatment will be allopurinol administration, ramping up the dose over a 2 month period to achieve a uric acid concentration of 6 mg/dL. Measurements of vascular and heart stiffness will be made before, during, and after. Part 3: Control, no treatment These individuals will undergo the same baseline and follow-up tests as the other two parts but have no treatments. Tests that will be completed before and after

Conditions

• Hyperuricemia

Interventions

Type	Name	Description
OTHER	low-fructose diet	Subjects will consume a four-month diet with the goal of reducing added sugar intake from ≥13% of energy to \<5% of energy and keeping their weight stable.
DRUG	Allopurinol	Subjects in the drug arm will take the drug allopurinol daily.

Timeline

• Start date: 2017-03-03
• Primary completion: 2018-12-01
• Completion: 2019-03-13
• First posted: 2017-03-10
• Last updated: 2019-04-17

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study