Gender Differences in the Metabolic Effects of Uric Acid

Withdrawn before enrolling · Early Phase 1

Conditions studied: Hyperuricemia

In brief

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.

Key facts

Study ID

NCT03076684

Run by

University of Missouri-Columbia

People needed

0

Starts

2017-03-03

Expected to finish

2019-03-13

Last updated by the study team

2019-04-17

Who can join

Age: 40 and older, up to 70. Sex: any. Healthy volunteers: accepted.

You may qualify if…

• Men and women with characteristics of the metabolic syndrome.
• 40-70 years of age
• Overweight/obese subjects with BMI 25.1 - 40.0 kg/m2
• Pre-diabetes defined as fasting glucose 100 - 125 mg/dL or 2h glucose 140 - 200 mg/dL
• Habitual diets containing ≥ 13.0% of energy from added sugars
• Serum uric acid ≥ 7.0 mg/dL for men and women

You may not qualify if…

• Renal dysfunction (defined by glomerular filtration rate [GFR] <60), abnormal thyroid function or liver disease
• Use of diuretics or azathioprine
• Diabetes defined as fasting glucose ≥ 125 mg/dL or HbA1c ≥ 7%
• Use of medications that interfere with lipid, protein, or carbohydrate metabolism, or occasional or regular tobacco use
• Habitual diets with low content of added sugars (<5% of total energy)
• History of gout , gouty arthritis, or uncontrolled hypertension
• Pregnant
• Vegetarian food restrictions (the diets consumed contain some meat, eggs and dairy)
• Alcohol intake: females > 70 g/wk, males >140 g/wk
• Inability to have an MRI

Where it is running

• University of Missouri — Columbia, Missouri, United States

Full record on ClinicalTrials.gov

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