Toxicity of Perirenal Fat in Overweight or Obese Subjects: A Pathophysiological Link Between Uric Acid Stones and Renal Ammonium Formation
Primary Purpose
Uric Acid Stones
Status
Completed
Phase
Not Applicable
Locations
France
Study Type
Interventional
Intervention
acid load test
Sponsored by
About this trial
This is an interventional other trial for Uric Acid Stones focused on measuring Renal Ammonium ;uric acid
Eligibility Criteria
Inclusion Criteria:
- 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
Exclusion Criteria:
- 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);
Sites / Locations
- CHU de Nice
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
acid load test
Arm Description
Outcomes
Primary Outcome Measures
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.
Secondary Outcome Measures
the perirenal fat thickness (right)
the average thickness of perirenal fat measured to the right
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
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.
Full Information
NCT ID
NCT02561858
First Posted
September 22, 2015
Last Updated
March 8, 2018
Sponsor
Centre Hospitalier Universitaire de Nice
1. Study Identification
Unique Protocol Identification Number
NCT02561858
Brief Title
Toxicity of Perirenal Fat in Overweight or Obese Subjects: A Pathophysiological Link Between Uric Acid Stones and Renal Ammonium Formation
Official Title
Toxicity of Perirenal Fat in Overweight or Obese Subjects: A Pathophysiological Link Between Uric Acid Stones and Renal Ammonium Formation
Study Type
Interventional
2. Study Status
Record Verification Date
March 2018
Overall Recruitment Status
Completed
Study Start Date
October 14, 2015 (Actual)
Primary Completion Date
June 24, 2016 (Actual)
Study Completion Date
September 29, 2016 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Centre Hospitalier Universitaire de Nice
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief 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. 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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Uric Acid Stones
Keywords
Renal Ammonium ;uric acid
7. Study Design
Primary Purpose
Other
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
20 (Actual)
8. Arms, Groups, and Interventions
Arm Title
acid load test
Arm Type
Experimental
Intervention Type
Other
Intervention Name(s)
acid load test
Primary Outcome Measure Information:
Title
the perirenal fat thickness (left)
Description
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.
Time Frame
baseline
Secondary Outcome Measure Information:
Title
the perirenal fat thickness (right)
Description
the average thickness of perirenal fat measured to the right
Time Frame
baseline
Title
NH4 + / NAE
Description
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
Time Frame
at day 7 of a standard diet
Title
net acid urinary flow
Description
This is the net acid urinary flow and report NH4 + / creat obtained when the urine pH became <5.5, in an acidic filler.
Time Frame
at day 7 of a standard diet and when urine pH became <5.5
10. Eligibility
Sex
Male
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
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
Exclusion Criteria:
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);
Facility Information:
Facility Name
CHU de Nice
City
Nice
ZIP/Postal Code
06000
Country
France
12. IPD Sharing Statement
Learn more about this trial
Toxicity of Perirenal Fat in Overweight or Obese Subjects: A Pathophysiological Link Between Uric Acid Stones and Renal Ammonium Formation
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