Effect of Reducing Uric Acid on Insulin Sensitivity and Oxidative Status

NCT ID: NCT01931527

Last Updated: 2018-08-14

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 31 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2006-07-31
• Study Completion Date: 2012-11-30

Brief 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.

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

Study Design

• Allocation Method: NON_RANDOMIZED
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: OTHER
• Blinding Strategy: NONE

Study Groups

Obese subjects with normal uric acid

Subjects with a body mass index = or \> 30 kg/m² with normal uric acid (= or \< 5 mg/dL)

Group Type: NO_INTERVENTION

No interventions assigned to this group

Obese subjects with high uric acid

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

Group Type: EXPERIMENTAL

Rasburicase

Intervention Type: DRUG

one single infusion of rasburicase (0.19 mg/kg FFM) infused over 30 min

Interventions

Rasburicase

one single infusion of rasburicase (0.19 mg/kg FFM) infused over 30 min

Intervention Type: DRUG

Other Intervention Names

Elitek

Eligibility Criteria

Inclusion Criteria

• obese (BMI 30-45 kg/m²);
• serum UA concentration either ≥5 mg/dL or ≤4.0 mg/dL (297 µmol/L)],

Exclusion Criteria

• 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)

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 65 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Washington University School of Medicine

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Samuel Klein, MD

Role: PRINCIPAL_INVESTIGATOR

Washington University School of Medicine

Locations

Washington University School of Medicine

St Louis, Missouri, United States

Countries

United States

Other Identifiers

06-0509 / 201104189

Identifier Type: -

Identifier Source: org_study_id