We updated the design of this site on December 18, 2017. Learn more.
ClinicalTrials.gov
ClinicalTrials.gov Menu

FFT, Inflammation, Lipid Metabolism, Blood Pressure and Organ Damage in Patients With Obesity, Chronic Kidney Disease (CKD).

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT01332526
Recruitment Status : Unknown
Verified March 2011 by Collegium Medicum w Bydgoszczy.
Recruitment status was:  Not yet recruiting
First Posted : April 11, 2011
Last Update Posted : April 18, 2011
Sponsor:
Collaborator:
Information provided by:

Study Description
Brief Summary:

Fructose intake from added sugars has increased dramatically over the last century and has recently been implicated as potential contributor to metabolic syndrome, obesity, hypertension, inflammation and kidney disease. Fructose differs from the other sugars because, uric acid is generated during its metabolism. Serum uric acid levels have been found to correlate with the intake of fructose and added sugars. In turn, an elevated serum uric acid has also been shown to be associated with increased risk for cardiovascular and metabolic diseases. On the other hand complexity of fructose metabolism in each individuals results of the various magnitude of hyperuricemia induced by fructose intake. The magnitude of uric acid production in each patient may reflect individual predisposition to endogenous urate production in a face of relatively normal fasting uric acid concentration. Therefore the oral fructose tolerance test might reveal an occult purine disturbances which plays casual role in either metabolic disturbances or organ damage.

The aim of this study is to see whether is a relationship between fructose induced hyperuricemia and metabolic disturbances , inflammatory state and organ damage in obese and various stages CKD patients.


Condition or disease
Obesity Chronic Kidney Disease Metabolic Syndrome

Detailed Description:

The study will be performed in two experimental groups. Proposed study groups Study I Patients with BMI> 30 and metabolic syndrome. Patient with BMI> 30 without metabolic syndrome. Normal healthy controls. Study II Patients with CKD stage III and uric acid < 7 mg/dl Patients with CKD stage III and uric acid > 7 mg/dl Patient with asymptomatic hyperuricemia and eGFR > 90 ml/min/1.73 m2, , uric acid > 7 mg/dl Hemodialysis patients

Characteristics of the particular patients group- including criteria:

10- 15 participants in each subset of each group age 18-65 y. Gender: females and males in equal proportion. Group I Patients with BMI> 30 and metabolic syndrome ( ATP III). Patient with BMI> 30 without metabolic syndrome. Normal healthy control- healthy persons( without renal disease, cardiovascular diseases, diabetes mellitus, BMI < 25;normotensives ).

Group II Patients with CKD stage III (GFR 30-59 ml/min/1,73 m2) and uric acid < 7 mg/dl.

  • without diabetes mellitus proteinuria < 3,5 g/24 h without immunosuppressive agents, ACEi, ARB, allopurinol treatment well controlled hypertension ( < 140/90 mmHg) Patients with CKD stage III(GFR 30-59 ml/min/1,73 m2) and uric acid > 7 mg/dl
  • without diabetes mellitus proteinuria < 3,5 g/24 h without immunosuppressive agents, ACEi, ARB, allopurinol treatment well controlled hypertension ( < 140/90 mmHg)

Patient with asymptomatic hyperuricemia, uric acid > 7 mg/dl with normal renal function Hemodialysis patients.

  • CKD: nondiabetic nephropathy
  • duration hemodialysis 3-48 months
  • Hb-11-13 g/dl
  • well controlled hypertension ( < 140/90 mmHg)
  • without ACEi, ARB, allopurinol treatment
  • residual diuresis will be estimated for last 48 hours-between mid and next dialysis Method of investigation All patients and controls ( but hemodialysis) will present after overnight fast. Baseline tests include 24 hr urine collection for: sodium, calcium, phosphorus, creatinine, uric acid, NAG, albumin will be carry out and the same morning fasting sample of blood for: creatinine, cystatin C , uric acid, sodium, glucose, insulin, triglycerides, HDL and LDL cholesterol, calcium, phosphorus, hsCRP. BP will be determined as the mean of three readings taken 5 min apart while sitting. Next in all patients and controls fructose tolerance test will be performed. The test consists of giving 1 gram/kg b.w. of fructose p.o. with blood collection at 0,30,60 and 120 min afterward for serum uric acid determination and uric acid area under the curve will be calculated. The calculated area under curve is the measure of occult uric acid disturbance when compared to controls.

Day before the urine collection the ABPM , BMI, IM (intima media ratio) , renal duplex ultrasound (RI) will be done

Measure BMI, waist circumference


Study Design

Study Type : Observational
Estimated Enrollment : 70 participants
Observational Model: Case Control
Time Perspective: Prospective
Official Title: The Oral Fructose Load Test and Inflammation, Lipid Metabolism, Blood Pressure and Organ Damage in Patients With Obesity, Chronic Kidney Disease With Comparison With Healthy Controls.
Study Start Date : May 2011

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Kidney Diseases
U.S. FDA Resources

Groups and Cohorts

Group/Cohort
Patients with BMI> 30 and metabolic syndrome ( ATP III).
Patients with BMI> 30 and metabolic syndrome ( ATP III).
Patient with BMI> 30 without metabolic syndrome.
Patient with BMI> 30 without metabolic syndrome.
Normal healthy control
healthy persons( without renal disease, cardiovascular diseases, diabetes mellitus, BMI < 25;normotensives ).
Patients with CKD stage III and uric acid < 7 mg/dl

Patients with CKD stage III (GFR 30-59 ml/min/1,73 m2) and uric acid < 7 mg/dl.

  • without diabetes mellitus proteinuria < 3,5 g/24 h without immunosuppressives agents, ACEi, ARB, allopurinol treatment well controlled hypertension ( < 140/90 mmHg)
Patients with CKD stage III and uric acid > 7 mg/dl

Patients with CKD stage III(GFR 30-59 ml/min/1,73 m2) and uric acid > 7 mg/dl

  • without diabetes mellitus proteinuria < 3,5 g/24 h without immunosuppressive agents, ACEi, ARB, allopurinol treatment well controlled hypertension ( < 140/90 mmHg)
Patient with asymptomatic hyperuricemia
Patient with asymptomatic hyperuricemia, uric acid > 7 mg/dl with normal renal function
Hemodialysis patients

Patient with asymptomatic hyperuricemia, uric acid > 7 mg/dl with normal renal function Hemodialysis patients.

  • CKD: nondiabetic nephropathy
  • duration hemodialysis 3-48 months
  • Hb-11-13 g/dl
  • well controlled hypertension ( < 140/90 mmHg)
  • without ACEi, ARB, allopurinol treatment
  • residual diuresis will be estimated for last 48 hours-between mid and next dialysis


Outcome Measures

Eligibility Criteria

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Ages Eligible for Study:   18 Years to 65 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Sampling Method:   Probability Sample
Study Population
Study I Patients with BMI> 30 and metabolic syndrome. Patient with BMI> 30 without metabolic syndrome. Normal healthy controls. Study II Patients with CKD stage III and uric acid < 7 mg/dl Patients with CKD stage III and uric acid > 7 mg/dl Patient with asymptomatic hiperuricemia and eGFR > 90 ml/min/1.73 m2, , uric acid > 7 mg/dl Hemodialysis patients
Criteria

Inclusion Criteria:

- Group I Patients with BMI> 30 and metabolic syndrome ( ATP III). Patient with BMI> 30 without metabolic syndrome. Normal healthy control- healthy persons( without renal disease, cardiovascular diseases, diabetes mellitus, BMI < 25;normotensives ).

Group II Patients with CKD stage III (GFR 30-59 ml/min/1,73 m2) and uric acid < 7 mg/dl.

  • without diabetes mellitus proteinuria < 3,5 g/24 h without immunosuppressives agents, ACEi, ARB, allopurinol treatment well controlled hypertension ( < 140/90 mmHg) Patients with CKD stage III(GFR 30-59 ml/min/1,73 m2) and uric acid > 7 mg/dl
  • without diabetes mellitus proteinuria < 3,5 g/24 h without immunosuppressive agents, ACEi, ARB, allopurinol treatment well controlled hypertension ( < 140/90 mmHg)

Patient with asymptomatic hyperuricemia, uric acid > 7 mg/dl with normal renal function Hemodialysis patients.

  • CKD: nondiabetic nephropathy
  • duration hemodialysis 3-48 months
  • Hb-11-13 g/dl
  • well controlled hypertension ( < 140/90 mmHg)
  • without ACEi, ARB, allopurinol treatment
  • residual diuresis will be estimated for last 48 hours-between mid and next dialysis

Exclusion Criteria:

  • immunosuppressive agents, ACEi, ARB, allopurinol treatment
  • diabetes mellitus
  • not well controlled hypertension ( > 140/90 mmHg)
  • proteinuria > 3,5 g/24 h
Contacts and Locations

Information from the National Library of Medicine

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): NCT01332526


Contacts
Contact: Jacek JM Manitius +48525854030 nerka@nerkacpro.pl

Sponsors and Collaborators
Collegium Medicum w Bydgoszczy
University of Colorado, Denver
Investigators
Study Chair: Jacek JM Manitius Department of Nephrology, Hypertension and Internal Diseases Nicolaus Copernicus University in Torun Poland Collegium Medicum in Bydgoszcz
More Information

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Richard Johnson M.D., Chief, Division of Renal Diseases and Hypertension
ClinicalTrials.gov Identifier: NCT01332526     History of Changes
Other Study ID Numbers: FFT Bydgoszcz
First Posted: April 11, 2011    Key Record Dates
Last Update Posted: April 18, 2011
Last Verified: March 2011

Keywords provided by Collegium Medicum w Bydgoszczy:
FFT
inflammation
lipid metabolism
hyperuricemia
Agents Affecting Uric Acid Metabolism

Additional relevant MeSH terms:
Obesity
Inflammation
Kidney Diseases
Renal Insufficiency, Chronic
Metabolic Syndrome X
Overnutrition
Nutrition Disorders
Overweight
Body Weight
Signs and Symptoms
Pathologic Processes
Urologic Diseases
Renal Insufficiency
Insulin Resistance
Hyperinsulinism
Glucose Metabolism Disorders
Metabolic Diseases
Uric Acid
Immunosuppressive Agents
Antioxidants
Molecular Mechanisms of Pharmacological Action
Protective Agents
Physiological Effects of Drugs
Immunologic Factors