NCT02561858

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

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
20

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Oct 2015

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

September 22, 2015

Completed
6 days until next milestone

First Posted

Study publicly available on registry

September 28, 2015

Completed
16 days until next milestone

Study Start

First participant enrolled

October 14, 2015

Completed
8 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 24, 2016

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

September 29, 2016

Completed
Last Updated

March 12, 2018

Status Verified

March 1, 2018

Enrollment Period

8 months

First QC Date

September 22, 2015

Last Update Submit

March 8, 2018

Conditions

Keywords

Renal Ammonium ;uric acid

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

EXPERIMENTAL
Other: acid load test

Interventions

acid load test

Eligibility Criteria

Age18 Years - 70 Years
Sexmale
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

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

Location

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

Locations