- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03076684
Gender Differences in the Metabolic Effects of Uric Acid
Study Overview
Status
Conditions
Intervention / Treatment
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
Study Type
Phase
- Early Phase 1
Contacts and Locations
Study Locations
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Missouri
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Columbia, Missouri, United States, 65212
- University of Missouri
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- 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
Exclusion Criteria:
- 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
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Basic Science
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
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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.
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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.
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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.
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Subjects in the drug arm will take the drug allopurinol daily.
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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.
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
vessel stiffness
Time Frame: Change from baseline at 4 months
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blood vessel stiffness is measured non-invasively with pulse wave velocity
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Change from baseline at 4 months
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Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Elizabeth Parks, PhD, University of Missouri-Columbia
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Anticipated)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 2007093
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
product manufactured in and exported from the U.S.
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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