Toxicity of Perirenal Fat in Overweight or Obese Subjects: A Pathophysiological Link Between Uric Acid Stones and Renal Ammonium Formation
1 other identifier
interventional
20
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for not_applicable
Started Oct 2015
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
September 22, 2015
CompletedFirst Posted
Study publicly available on registry
September 28, 2015
CompletedStudy Start
First participant enrolled
October 14, 2015
CompletedPrimary Completion
Last participant's last visit for primary outcome
June 24, 2016
CompletedStudy Completion
Last participant's last visit for all outcomes
September 29, 2016
CompletedMarch 12, 2018
March 1, 2018
8 months
September 22, 2015
March 8, 2018
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
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.
baseline
Secondary Outcomes (3)
the perirenal fat thickness (right)
baseline
NH4 + / NAE
at day 7 of a standard diet
net acid urinary flow
at day 7 of a standard diet and when urine pH became <5.5
Study Arms (1)
acid load test
EXPERIMENTALInterventions
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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);
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
CHU de Nice
Nice, 06000, France
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- NA
- Masking
- NONE
- Purpose
- OTHER
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
September 22, 2015
First Posted
September 28, 2015
Study Start
October 14, 2015
Primary Completion
June 24, 2016
Study Completion
September 29, 2016
Last Updated
March 12, 2018
Record last verified: 2018-03