Gender Differences in the Metabolic Effects of Uric Acid
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|ClinicalTrials.gov Identifier: NCT03076684|
Recruitment Status : Withdrawn (Preliminary data collected and diets developed. Funding has ended and data used to support a larger application to test the hypothesis.)
First Posted : March 10, 2017
Last Update Posted : April 17, 2019
|Condition or disease||Intervention/treatment||Phase|
|Hyperuricemia||Other: low-fructose diet Drug: Allopurinol||Early Phase 1|
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
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||0 participants|
|Intervention Model:||Parallel Assignment|
|Intervention Model Description:||There are three arms of this study: a diet-treated group, a drug-treated group and a control group.|
|Masking:||None (Open Label)|
|Primary Purpose:||Basic Science|
|Official Title:||Gender Differences in the Metabolic Effects of Uric Acid|
|Actual Study Start Date :||March 3, 2017|
|Estimated Primary Completion Date :||December 2018|
|Actual Study Completion Date :||March 13, 2019|
Experimental: low-fructose diet
Intervention: low-fructose 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.
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.
Experimental: allopurinol treatment
Subjects participating in the allopurinol treatment arm will begin with an initial dose of drug of 100 mg/d p.o. daily for 2 wks. The dose is then slowly increased over the next 8 wks to achieve a serum uric acid concentration of 6 mg/dL (maximum allopurinol dose is 800 mg/d). Once uric acid reaches 6 mg/dL, the subject stays on this dose and is seen for the interim visit (4 months), at which time all procedures are repeated. After this, drug treatment continues for another 4 months and the subject returns for the final visit at 8 months. The same procedures performed at baseline are repeated at this time. The dose of allopurinol will be taken the morning of the final visit.
Subjects in the drug arm will take the drug allopurinol daily.
No Intervention: control arm
After completion of the baseline visit (procedures described above), subjects participating in the control arm are not seen again until the 4-month time point, when the same procedures performed at baseline are repeated, except for the MRI. Following this, they are seen again at 8-months, when all baseline procedures are repeated. Cardiac MRI and labeled water consumption occur at the baseline and final visits.
- vessel stiffness [ Time Frame: Change from baseline at 4 months ]blood vessel stiffness is measured non-invasively with pulse wave velocity
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03076684
|United States, Missouri|
|University of Missouri|
|Columbia, Missouri, United States, 65212|
|Principal Investigator:||Elizabeth Parks, PhD||University of Missouri-Columbia|