Uric Acid StonesNCT02561858
Toxicity of Perirenal Fat in Overweight or Obese Subjects: A Pathophysiological Link Between Uric Acid Stones and Renal Ammonium Formation
A study testing acid load test in people with Uric Acid Stones, run by Centre Hospitalier Universitaire de Nice at 1 site in France.
Trial summary
Patients who are overweight or obese, diabetic or not, share with those who are suffering from uric stones the same way to remove abnormal acidity of the body in urine, ie a kidney ammoniogenesis default. Read more about this study
- Who is it for?
- Ages 18 to 70 years, men only
- Conditions the study is for
- Uric Acid Stones
- What is being tested?
- acid load test
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 1 siteFrance
- Study dates
- 14 Oct 2015to 29 Sep 2016
- Phase
- Interventional
- 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 70 years
- Men only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Urolithiasis Uric defined by more than 90% of uric acid anhydrous and / or dihydrate or calcium lithiasis defined by more than 90% mono calcium oxalate and / or dihydrate, and / or carbapatite and / or brushite;
- Overweight and obesity defined by 25 <BMI <35 kg / m2
Who cannot join
- staghorn lithiasis, stones struvite or cystine;
- Primary hyperparathyroidism;
- Hyperthyroidism;
- Any form of calcium or uric lithiasis secondary;
- Abnormal kidney structure (cysts, cortical thinning, kidney tumor);
Trial locations and contacts
1 site in 1 country.
About this study
Patients who are overweight or obese, diabetic or not, share with those who are suffering from uric stones the same way to remove abnormal acidity of the body in urine, ie a kidney ammoniogenesis default. This results in an overly acidic urine pH which is directly pathogenic in people predisposed to develop uric stones because the precipitation of urate soluble uric acid is accelerated in acid medium.
Excess visceral fat, particularly perirenal, this defect may promote formation of renal ammonium. Indeed, the perirenal fat is adjacent to the renal cortex and shares with it a common arterial supply via the plexus Turner. Adipokines and fatty acids of the perirenal fat are predisposed to gain the renal cortex, seat of the ammoniogenesis. In humans the pathogenic role of the perirenal fat is demonstrated in chronic kidney disease and essential hypertension. However, the amount of fat and perirenal that of intra-abdominal fat are positively correlated.
Read more
Investigators hypothesis is that the perirenal fat also exert a pathogenic role in uric because of anatomical links between kidney stones and greasy environment and because excess fatty acids reaching the renal cortex decreases ammoniogenesis in an animal model metabolic syndrome.
For the test, the investigators will compare the amount of fat and perirenal renal ability to form ammonium in patients with uric or calcium lithiasis taking into account the amount of intra-abdominal fat.
- Conditions
- Uric Acid Stones
- Being tested
- acid load test
- Keywords
- Renal Ammonium ;uric acid
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
acid load testOther
| Study group | Role | What they receive |
|---|---|---|
| acid load test | Experimental | Not described Receives: Other: acid load test |
What is being measured
The primary outcome is the main question the study is designed to answer.
the perirenal fat thickness (left)
This is the perirenal fat thickness measured between the left posterior wall of the kidney and the posterior wall of the abdominal cavity on a TDM section in the plane of the left renal vein.
Measured: baseline
Secondary outcomes (3)
the perirenal fat thickness (right)
the average thickness of perirenal fat measured to the right
Measured: baseline
NH4 + / NAE
It is the ratio NH4 + / NAE measured over 24 hours of urine collected at day 7 of a standard diet; it determines from acid removed as ammonium whose production is regulated physiologically by the kidneys
Measured: at day 7 of a standard diet
net acid urinary flow
This is the net acid urinary flow and report NH4 + / creat obtained when the urine pH became <5.5, in an acidic filler.
Measured: at day 7 of a standard diet and when urine pH became <5.5
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Sep 2015 (estimated)
- Study start14 Oct 2015
- Primary completion24 Jun 2016
- Study completion29 Sep 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Uric Acid StonesStudies of the same condition, open and under way.
- More trials run by Centre Hospitalier Universitaire de NiceThe 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
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 20 participants (actual)
Sponsor and investigators
- Lead sponsor
- Centre Hospitalier Universitaire de Nice
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02561858
- Sponsor's protocol ID
- 15-AOI-07
- Status last verified
- Mar 2018
- First submitted
- 22 Sep 2015
- Last updated
- 12 Mar 2018
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 12 Mar 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Toxicity of Perirenal Fat in Overweight or Obese Subjects: A Pathophysiological Link Between Uric Acid Stones and Renal Ammonium Formation
- ClinicalTrials.gov ID
- NCT02561858
- Acronym / sponsor ID
- 15-AOI-07
- Conditions
- Uric Acid Stones
- Keywords
- Renal Ammonium ;uric acid
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 20 participants (actual)
- Lead sponsor
- Centre Hospitalier Universitaire de NiceUniversity, hospital or other
- Study start
- 14 Oct 2015 (actual)
- Primary completion
- 24 Jun 2016 (actual)
- Study completion
- 29 Sep 2016 (actual)
- First posted
- 28 Sep 2015 (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.
Patients who are overweight or obese, diabetic or not, share with those who are suffering from uric stones the same way to remove abnormal acidity of the body in urine, ie a kidney ammoniogenesis default. This results in an overly acidic urine pH which is directly pathogenic in people predisposed to develop uric stones because the precipitation of urate soluble uric acid is accelerated in acid medium.
Excess visceral fat, particularly perirenal, this defect may promote formation of renal ammonium. Indeed, the perirenal fat is adjacent to the renal cortex and shares with it a common arterial supply via the plexus Turner. Adipokines and fatty acids of the perirenal fat are predisposed to gain the renal cortex, seat of the ammoniogenesis. In humans the pathogenic role of the perirenal fat is demonstrated in chronic kidney disease and essential hypertension. However, the amount of fat and perirenal that of intra-abdominal fat are positively correlated.
Investigators hypothesis is that the perirenal fat also exert a pathogenic role in uric because of anatomical links between kidney stones and greasy environment and because excess fatty acids reaching the renal cortex decreases ammoniogenesis in an animal model metabolic syndrome.
For the test, the investigators will compare the amount of fat and perirenal renal ability to form ammonium in patients with uric or calcium lithiasis taking into account the amount of intra-abdominal fat.
Study design
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| acid load test | Experimental | Other: acid load test |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Urolithiasis Uric defined by more than 90% of uric acid anhydrous and / or dihydrate or calcium lithiasis defined by more than 90% mono calcium oxalate and / or dihydrate, and / or carbapatite and / or brushite;
- Overweight and obesity defined by 25 <BMI <35 kg / m2
Key exclusion criteria (5 listed)
- staghorn lithiasis, stones struvite or cystine;
- Primary hyperparathyroidism;
- Hyperthyroidism;
- Any form of calcium or uric lithiasis secondary;
- Abnormal kidney structure (cysts, cortical thinning, kidney tumor);
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 |
|---|---|---|
| acid load test | Other | acid load test |
Primary outcome
the perirenal fat thickness (left)
Time frame: baseline
This is the perirenal fat thickness measured between the left posterior wall of the kidney and the posterior wall of the abdominal cavity on a TDM section in the plane of the left renal vein.
3 secondary outcomes
the perirenal fat thickness (right)
Time frame: baseline
NH4 + / NAE
Time frame: at day 7 of a standard diet
net acid urinary flow
Time frame: at day 7 of a standard diet and when urine pH became <5.5
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Mar 2018.
Related trials for Uric Acid Stones
Active, not recruitingObservational study
Multicenter Study to Develop a Model to Identify Uric Acid Urinary Tract Stones Using CT and Lab Tests
Urinary Tract Stones
RecruitingPhase 1
Impact of Sodium Bicarbonate on 24-hour Urine Parameters in Hypocitriuric and Uric Acid Stone Formers
Uric Acid Stones
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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing acid load test in people with Uric Acid Stones, run by Centre Hospitalier Universitaire de Nice at 1 site in France.
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 5 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 12 Mar 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 France. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
the perirenal fat thickness (left) (time frame: baseline). 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 12 Mar 2018.