Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu

Toxicity of Perirenal Fat in Overweight or Obese Subjects: A Pathophysiological Link Between Uric Acid Stones and Renal Ammonium Formation

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: NCT02561858
Recruitment Status : Completed
First Posted : September 28, 2015
Last Update Posted : March 12, 2018
Sponsor:
Information provided by (Responsible Party):
Centre Hospitalier Universitaire de Nice

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.


Condition or disease Intervention/treatment Phase
Uric Acid Stones Other: acid load test Not Applicable

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 20 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Other
Official Title: Toxicity of Perirenal Fat in Overweight or Obese Subjects: A Pathophysiological Link Between Uric Acid Stones and Renal Ammonium Formation
Actual Study Start Date : October 14, 2015
Actual Primary Completion Date : June 24, 2016
Actual Study Completion Date : September 29, 2016

Resource links provided by the National Library of Medicine

Drug Information available for: Uric Acid

Arm Intervention/treatment
Experimental: acid load test Other: acid load test



Primary Outcome Measures :
  1. 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.


Secondary Outcome Measures :
  1. the perirenal fat thickness (right) [ Time Frame: baseline ]
    the average thickness of perirenal fat measured to the right

  2. NH4 + / NAE [ Time Frame: at day 7 of a standard diet ]
    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

  3. net acid urinary flow [ Time Frame: at day 7 of a standard diet and when urine pH became <5.5 ]
    This is the net acid urinary flow and report NH4 + / creat obtained when the urine pH became <5.5, in an acidic filler.



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.


Layout table for eligibility information
Ages Eligible for Study:   18 Years to 70 Years   (Adult, Older Adult)
Sexes Eligible for Study:   Male
Accepts Healthy Volunteers:   No
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);

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): NCT02561858


Locations
Layout table for location information
France
CHU de Nice
Nice, France, 06000
Sponsors and Collaborators
Centre Hospitalier Universitaire de Nice

Layout table for additonal information
Responsible Party: Centre Hospitalier Universitaire de Nice
ClinicalTrials.gov Identifier: NCT02561858     History of Changes
Other Study ID Numbers: 15-AOI-07
First Posted: September 28, 2015    Key Record Dates
Last Update Posted: March 12, 2018
Last Verified: March 2018
Keywords provided by Centre Hospitalier Universitaire de Nice:
Renal Ammonium ;uric acid
Additional relevant MeSH terms:
Layout table for MeSH terms
Nephrolithiasis
Overweight
Body Weight
Signs and Symptoms
Kidney Diseases
Urologic Diseases
Urolithiasis
Uric Acid
Antioxidants
Molecular Mechanisms of Pharmacological Action
Protective Agents
Physiological Effects of Drugs