ObesityNCT01332526
FFT, Inflammation, Lipid Metabolism, Blood Pressure and Organ Damage in Patients With Obesity, Chronic Kidney Disease (CKD).
An observational study of Obesity and Chronic Kidney Disease, run by Collegium Medicum w Bydgoszczy.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Obesity, Chronic Kidney Disease, Metabolic Syndrome
- How many people
- 70 participants
- Where
- No sites listed yet
- Study dates
- May 2011to not given
- Phase
- Observational
- 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 18 to 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
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
Who may be able to join
- 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
Show all 11Show fewer
- 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
Who cannot join
- immunosuppressive agents, ACEi, ARB, allopurinol treatment
- diabetes mellitus
- not well controlled hypertension ( > 140/90 mmHg)
- proteinuria > 3,5 g/24 h
Trial locations and contacts
No sites are listed yet.
About this study
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.
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.
Read the 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
- Conditions
- Obesity, Chronic Kidney Disease, Metabolic Syndrome
- Keywords
- FFT, inflammation, lipid metabolism, hyperuricemia, Agents Affecting Uric Acid Metabolism
- Medical subject headings
- Obesity, Renal Insufficiency, Chronic, Metabolic Syndrome, Inflammation, Hyperuricemia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| 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 |
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Apr 2011 (estimated)
- Study startMay 2011
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for ObesityStudies of the same condition, open and under way.
- 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
- Observational
- Observational model
- Case-control
- Time perspective
- Prospective
- Enrolment
- 70 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Collegium Medicum w Bydgoszczy
- Sponsor type
- University, hospital or other
- Collaborators
- University of Colorado, Denver
- Investigators
- Jacek JM Manitius, Study chair, Department of Nephrology, Hypertension and Internal Diseases Nicolaus Copernicus University in Torun Poland Collegium Medicum in Bydgoszcz
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01332526
- Sponsor's protocol ID
- FFT Bydgoszcz
- Status last verified
- Mar 2011
- First submitted
- 31 Mar 2011
- Last updated
- 18 Apr 2011
- Results posted
- No
Publications
Donderski R, Miskowiec-Wisniewska I, Kretowicz M, Grajewska M, Manitius J, Kaminska A, Junik R, Siodmiak J, Stefanska A, Odrowaz-Sypniewska G, Pluta A, Lanaspa M, Johnson RJ. The fructose tolerance test in patients with chronic kidney disease and metabolic syndrome in comparison to healthy controls. BMC Nephrol. 2015 May 3;16:68. doi: 10.1186/s12882-015-0048-y.
PubMed 25935771
Study at a glance
From the registry record, last updated by the sponsor on 18 Apr 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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.
- ClinicalTrials.gov ID
- NCT01332526
- Acronym / sponsor ID
- FFT Bydgoszcz
- Conditions
- Obesity, Chronic Kidney Disease, Metabolic Syndrome
- Keywords
- FFT, inflammation, lipid metabolism, hyperuricemia, Agents Affecting Uric Acid Metabolism
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 70 participants (estimated)
- Lead sponsor
- Collegium Medicum w BydgoszczyUniversity, hospital or other
- Collaborators
- University of Colorado, Denver
- Study start
- May 2011
- First posted
- 11 Apr 2011 (estimated)
- 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.
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.
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
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 7
| Arm | Type | Receives |
|---|---|---|
| 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 |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- 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
Key inclusion criteria (11 listed)
- 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.
Key exclusion criteria (4 listed)
- immunosuppressive agents, ACEi, ARB, allopurinol treatment
- diabetes mellitus
- not well controlled hypertension ( > 140/90 mmHg)
- proteinuria > 3,5 g/24 h
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Not reported in the source record.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Apr 2011.
- Derived from this study: PubMed 25935771Donderski R, Miskowiec-Wisniewska I, Kretowicz M, Grajewska M, Manitius J, Kaminska A, Junik R, Siodmiak J, Stefanska A, Odrowaz-Sypniewska G, Pluta A, Lanaspa M, Johnson RJ. The fructose tolerance test in patients with chronic kidney disease and metabolic syndrome in comparison to healthy controls. BMC Nephrol. 2015 May 3;16:68. doi: 10.1186/s12882-015-0048-y.
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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.
Jacek JM Manitius study chair
Department of Nephrology, Hypertension and Internal Diseases Nicolaus Copernicus University in Torun Poland Collegium Medicum in Bydgoszcz
Questions about this trial
What is this clinical trial studying?
An observational study of Obesity and Chronic Kidney Disease, run by Collegium Medicum w Bydgoszczy.
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 11 inclusion and 4 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: status not confirmed, as of the sponsor's last update on 18 Apr 2011. Status can change between updates, so confirm with the study contact before making plans.
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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Jacek JM Manitius (+48525854030, nerka@nerkacpro.pl), or a site near the patient. AzTrials does not enrol participants or take referrals.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01332526, which also lists 1 linked publication.
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 18 Apr 2011.