ObesityUANCT01931527
Effect of Reducing Uric Acid on Insulin Sensitivity and Oxidative Status
A study testing Rasburicase in people with Obesity and Metabolic Syndrome, run by Washington University School of Medicine at 1 site in United States.
Trial summary
The purpose of this study is to learn more about what is the effect of uric acid on oxidative stress and on the way the body metabolizes sugar in obese people. Understanding this may lead to better diseases such as diabetes. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Obesity, Metabolic Syndrome, Hyperuricemia
- What is being tested?
- Rasburicase
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 31 participants
- Where
- 1 siteUnited States
- Study dates
- Jul 2006to Nov 2012
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 18 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- obese (BMI 30-45 kg/m²);
- serum UA concentration either ≥5 mg/dL or ≤4.0 mg/dL (297 µmol/L)],
Who cannot join
- renal dysfunction (serum creatinine >1.5 mg/dL);
- pregnancy or lactating;
- take urate-lowering agents, thiazide diuretics, prednisone or medications containing aspirin or other salicylates;
- history of xanthinuria, type 2 diabetes or other significant organ system dysfunction;
- have G6PD deficiency;
- use hormone-replacement or oral-contraceptive therapy;
- smoke tobacco;
- anemic (Hb <10 g/dl)
Trial locations and contacts
1 site in 1 country.
United States1 site
Washington University School of Medicine
St Louis, Missouri, 63110
About this study
Official title: Effect of Plasma Uric Acid on Insulin Sensitivity, Endothelial Function and Inflammation
The purpose of this study is to learn more about what is the effect of uric acid on oxidative stress and on the way the body metabolizes sugar in obese people. Understanding this may lead to better diseases such as diabetes.
Read the detailed description
It has been hypothesized that oxidative stress is involved in the pathogenesis of insulin resistance associated with obesity. Circulating uric acid (UA) is the body's major endogenous plasma antioxidant. Therefore, the investigators evaluated whether alterations in serum UA concentration affect: 1) systemic and skeletal muscle oxidative stress, 2) total antioxidant capacity, and 4) skeletal muscle insulin sensitivity during a hyperinsulinemic-euglycemic clamp.
- Conditions
- Obesity, Metabolic Syndrome, Hyperuricemia
- Being tested
- Rasburicase
- Keywords
- Obesity, Metabolic syndrome, Hyperuricemia
- Medical subject headings
- Obesity, Metabolic Syndrome, Hyperuricemia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
RasburicaseDrug
Also called Elitek
one single infusion of rasburicase (0.19 mg/kg FFM) infused over 30 min
| Study group | Role | What they receive |
|---|---|---|
| Obese subjects with normal uric acid | No intervention | Subjects with a body mass index = or > 30 kg/m² with normal uric acid (= or < 5 mg/dL) |
| Obese subjects with high uric acid | Experimental | Subjects with a body mass index = or > 30 kg/m² with high uric acid (>6 mg/dL)
Intervention: one single infusion of rasburicase (0.19 mg/kg FFM) infused over 30 min Receives: Drug: Rasburicase |
What is being measured
The primary outcome is the main question the study is designed to answer.
Percent Increase in Insulin-stimulated Glucose Uptake
Uric acid will be reduced to 0 with a 30 minute infusion of a uricase (Elitek, Sanofi-Aventis). A hyperinsulinemic-euglycemic clamp procedure in conjunction with stable isotope glucose tracer infusion will be used to measure percent increase in insulin-stimulated glucose uptake in obese subjects with high uric acid before and after uric acid reduction.
Measured: 12 hours after reducing uric acid
Secondary outcomes (7)
The Effect of Reducing Uric Acid on Oxidative Status
Uric acid will be reduced to 0 with a 30 minute infusion of a uricase (Elitek, Sanofi-Aventis). Systemic (urinary isoprostanes) and skeletal muscle (carbonylated protein ratio) oxidative stress and total antioxidant capacity (plasma TRAP and FRAP) will be measured in obese subjects with high uric acid before and after uric acid reduction. Levels of isoprostanes were normalized to urinary creatinine and reported at ng/mg.
Measured: 12 hours after reducing uric acid
Baseline Carbonylated Protein Ratio
Baseline ratio of total carbonylated proteins to the loading control protein Ran in skeletal muscle
Measured: Before reducing uric acid
AFTER Rasburicase Carbonylated Protein Ratio
Baseline ratio of total carbonylated proteins to the loading control protein Ran in skeletal muscle
Measured: 12 hours after reducing uric acid
Baseline Plasma TRAP
Total Radical-Trapping Antioxidant Potential
Measured: Before reducing uric acid
AFTER Rasburicase Plasma TRAP
Total Radical-Trapping Antioxidant Potential
Measured: 12 hours after reducing uric acid
Baseline Plasma FRAP
Ferric-Reducing Antioxidant Potential
Measured: Before reducing uric acid
AFTER Rasburicase Plasma FRAP (Fe⁺² · Lˉ¹)
Ferric-Reducing Antioxidant Potential
Measured: 12 hours after reducing uric acid
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Aug 2013 (estimated)
- Study startJul 2006
- Primary completionJun 2008
- Study completionNov 2012
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for ObesityStudies of the same condition, open and under way.
- More trials run by Washington University School of MedicineThe 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
- Phase N/A
- Primary purpose
- Other
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 31 participants (actual)
Sponsor and investigators
- Lead sponsor
- Washington University School of Medicine
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Samuel Klein, MD, Principal investigator, Washington University School of Medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01931527
- Sponsor's protocol ID
- 06-0509 / 201104189
- Acronym
- UA
- Status last verified
- Jul 2018
- First submitted
- 23 Aug 2013
- Last updated
- 14 Aug 2018
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 14 Aug 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Plasma Uric Acid on Insulin Sensitivity, Endothelial Function and Inflammation
- ClinicalTrials.gov ID
- NCT01931527
- Acronym / sponsor ID
- UA / 06-0509 / 201104189
- Conditions
- Obesity, Metabolic Syndrome, Hyperuricemia
- Keywords
- Obesity, Metabolic syndrome, Hyperuricemia
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 31 participants (actual)
- Lead sponsor
- Washington University School of MedicineUniversity, hospital or other
- Study start
- Jul 2006
- Primary completion
- Jun 2008 (actual)
- Study completion
- Nov 2012 (actual)
- First posted
- 29 Aug 2013 (estimated)
- Results
- Posted 15 May 2015
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of this study is to learn more about what is the effect of uric acid on oxidative stress and on the way the body metabolizes sugar in obese people. Understanding this may lead to better diseases such as diabetes.
Detailed description
It has been hypothesized that oxidative stress is involved in the pathogenesis of insulin resistance associated with obesity. Circulating uric acid (UA) is the body's major endogenous plasma antioxidant. Therefore, the investigators evaluated whether alterations in serum UA concentration affect: 1) systemic and skeletal muscle oxidative stress, 2) total antioxidant capacity, and 4) skeletal muscle insulin sensitivity during a hyperinsulinemic-euglycemic clamp.
Study design
- Primary purpose
- Other
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Obese subjects with normal uric acid | No intervention | –Subjects with a body mass index = or > 30 kg/m² with normal uric acid (= or < 5 mg/dL) |
| Obese subjects with high uric acid | Experimental | Drug: RasburicaseSubjects with a body mass index = or > 30 kg/m² with high uric acid (>6 mg/dL) Intervention: one single infusion of rasburicase (0.19 mg/kg FFM) infused over 30 min |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- obese (BMI 30-45 kg/m²);
- serum UA concentration either ≥5 mg/dL or ≤4.0 mg/dL (297 µmol/L)],
Key exclusion criteria (8 listed)
- renal dysfunction (serum creatinine >1.5 mg/dL);
- pregnancy or lactating;
- take urate-lowering agents, thiazide diuretics, prednisone or medications containing aspirin or other salicylates;
- history of xanthinuria, type 2 diabetes or other significant organ system dysfunction;
- have G6PD deficiency;
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 |
|---|---|---|
| RasburicaseAlso: Elitekone single infusion of rasburicase (0.19 mg/kg FFM) infused over 30 min | Drug | Obese subjects with high uric acid |
Primary outcome
Percent Increase in Insulin-stimulated Glucose Uptake
Time frame: 12 hours after reducing uric acid
Uric acid will be reduced to 0 with a 30 minute infusion of a uricase (Elitek, Sanofi-Aventis). A hyperinsulinemic-euglycemic clamp procedure in conjunction with stable isotope glucose tracer infusion will be used to measure percent increase in insulin-stimulated glucose uptake in obese subjects with high uric acid before and after uric acid reduction.
7 secondary outcomes
The Effect of Reducing Uric Acid on Oxidative Status
Time frame: 12 hours after reducing uric acid
Baseline Carbonylated Protein Ratio
Time frame: Before reducing uric acid
AFTER Rasburicase Carbonylated Protein Ratio
Time frame: 12 hours after reducing uric acid
Baseline Plasma TRAP
Time frame: Before reducing uric acid
AFTER Rasburicase Plasma TRAP
Time frame: 12 hours after reducing uric acid
Baseline Plasma FRAP
Time frame: Before reducing uric acid
AFTER Rasburicase Plasma FRAP (Fe⁺² · Lˉ¹)
Time frame: 12 hours after reducing uric acid
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Aug 2018.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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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.
Samuel Klein, MD principal investigator
Washington University School of Medicine
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Rasburicase in people with Obesity and Metabolic Syndrome, run by Washington University School of Medicine 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 2 inclusion and 8 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: finished, as of the sponsor's last update on 14 Aug 2018. 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.
Are results available for this study?
Yes. Results are posted in the registry (first posted 15 May 2015). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Percent Increase in Insulin-stimulated Glucose Uptake (time frame: 12 hours after reducing uric acid). 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 14 Aug 2018.