HyperuricemiaEarly Phase 1NCT03076684
Gender Differences in the Metabolic Effects of Uric Acid
A Early Phase 1 study testing low-fructose diet and Allopurinol in people with Hyperuricemia, run by University of Missouri-Columbia at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 40 to 70 yearsHealthy volunteers can take part
- Conditions the study is for
- Hyperuricemia
- What is being tested?
- low-fructose diet and Allopurinol
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 0 participants
- Where
- 1 siteUnited States
- Study dates
- 3 Mar 2017to 13 Mar 2019
- Phase
- Early Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 40 to 70 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Show all 10Show fewer
- 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
Trial locations and contacts
1 site in 1 country.
About this study
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.
Read the 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
- Being tested
- low-fructose diet, Allopurinol
- Medical subject headings
- Hyperuricemia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
low-fructose dietOther
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.
AllopurinolDrug
Subjects in the drug arm will take the drug allopurinol daily.
| Study group | Role | What they receive |
|---|---|---|
| low-fructose diet | Experimental | 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. Receives: Other: low-fructose diet |
| allopurinol treatment | Experimental | 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. Receives: Drug: Allopurinol |
| control arm | No intervention | 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. |
What is being measured
The primary outcome is the main question the study is designed to answer.
vessel stiffness
blood vessel stiffness is measured non-invasively with pulse wave velocity
Measured: Change from baseline at 4 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Mar 2017
- Study start3 Mar 2017
- Primary completionDec 2018 (estimated)
- Study completion13 Mar 2019
Why it stopped: Preliminary data collected and diets developed. Funding has ended and data used to support a larger application to test the hypothesis.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HyperuricemiaStudies of the same condition, open and under way.
- More trials run by University of Missouri-ColumbiaThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Early Phase 1
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- 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)
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Missouri-Columbia
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Elizabeth Parks, University of Missouri-Columbia
- Investigators
- Elizabeth Parks, PhD, Principal investigator, University of Missouri-Columbia
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03076684
- Sponsor's protocol ID
- 2007093
- Status last verified
- Apr 2019
- First submitted
- 1 Mar 2017
- Last updated
- 17 Apr 2019
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 17 Apr 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Gender Differences in the Metabolic Effects of Uric Acid
- ClinicalTrials.gov ID
- NCT03076684
- Acronym / sponsor ID
- 2007093
- Conditions
- Hyperuricemia
- Phase
- Early Phase 1
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: Preliminary data collected and diets developed. Funding has ended and data used to support a larger application to test the hypothesis.
- Enrolment
- 0 participants (actual)
- Lead sponsor
- University of Missouri-ColumbiaUniversity, hospital or other
- Study start
- 3 Mar 2017 (actual)
- Primary completion
- Dec 2018 (estimated)
- Study completion
- 13 Mar 2019 (actual)
- First posted
- 10 Mar 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
- Model description
- There are three arms of this study: a diet-treated group, a drug-treated group and a control group.
| Arm | Type | Receives |
|---|---|---|
| low-fructose diet | Experimental | Other: low-fructose dietIntervention: 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. |
| allopurinol treatment | Experimental | Drug: AllopurinolSubjects 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. |
| control arm | No intervention | –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. |
Who may qualify
- Ages
- 40 to 70 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 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
Key exclusion criteria (10 listed)
- 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)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| low-fructose dietSubjects 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 |
| AllopurinolSubjects in the drug arm will take the drug allopurinol daily. | Drug | allopurinol treatment |
Primary outcome
vessel stiffness
Time frame: Change from baseline at 4 months
blood vessel stiffness is measured non-invasively with pulse wave velocity
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Apr 2019.
- Individual participant dataSharing planned: No
Related trials for Hyperuricemia
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A Study of Dotinurad Versus Allopurinol in Participants With Gout
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A Study of Dotinurad Versus Allopurinol in Tophaceous Gout
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Elizabeth Parks, PhD principal investigator
University of Missouri-Columbia
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Early Phase 1 study testing low-fructose diet and Allopurinol in people with Hyperuricemia, run by University of Missouri-Columbia at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: withdrawn, as of the sponsor's last update on 17 Apr 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Early Phase 1 (sometimes called Phase 0) studies give a very small amount of a treatment to a few people, mainly to see how the body handles it.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study was withdrawn before enrolling participants, so there are no results.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
vessel stiffness (time frame: Change from baseline at 4 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 Apr 2019.