We try to find a new standard within the field of ''MicroRNA'' proteins, that swim around in peoples blood and/or urine. MicroRNA's are very small proteins, that switches of genes in the cells, they are able to switch genes…
ID
Source
Brief title
Condition
- Other condition
- Lipid metabolism disorders
- Renal disorders (excl nephropathies)
Synonym
Health condition
obesitas
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
The main outcome parameter will be a top-5 of differentially expressed miRs in
plasma and urine between obese progressors to albuminuria versus
non-progressors, adjusted for miRs associated with progression to albuminuria
not related to obesity.
Secondary outcome
- albuminuria from 24h urine
- renal function as assessed by 24h urinary creatinine clearance
- anthropometric measures of obesity (BMI, waist/hip ratio)
- fasting glucose and post OGTT glucose
- automated blood pressure (dynamap)
- non-invasive assessment of microcirculation using orthogonal polarization
spectral (OPS) imaging of oral mucosa.
- serum/plasma parameters of obesity-associated parameters of inflammation
(hsCRP), endothelial dysfunction (sICAM-1, sVCAM-1, sE-Selectine) and
coagulation (PA1-1)
- smoking history, alcohol use
- medication including hormonal replacement therapy in women
- medical history / record review for cardiovascular history and/or de novo
renal disease.
Background summary
Serious overweigt is one of the criteria that deem it unsafe to donate a
kidney. This is due to the reason that among overweight persons the
renalfunction may deteriorate more quickly after donation. At this moment the
Body Mass Index or BMI is the best standard to estimate a serious overweight. A
person is seriously overweight when his of hers BMI is higher than 30(kg/m2).
However the BMI does not predict as well wich serious overweight is harmfull
and wich are not. A certain number of people, who are seriously overweight may
be perfectly able to donate a kidney safely, that is if we had a beter standard
to asses the risk. With this study we hope to find this standard in the
blood/urine. This is of great importance because the Dutch population is
getting fatter and possible donors are getting more seriously overweight(30
kg/m2).
Study objective
We try to find a new standard within the field of ''MicroRNA'' proteins, that
swim around in peoples blood and/or urine. MicroRNA's are very small proteins,
that switches of genes in the cells, they are able to switch genes on/off. In
this matter they control a lot of processes(of disease). With this research we
hope te find a number of MicroRNA's that are involved with the arise of kindney
damage in overweight people. MicroRNA's are measurable in the blood and in 24
hr urine. The MicroRNA's found may serve as a future standard to predict wich
seriously overweight people are, and wich seriously overweight people are not,
eligible to safely donate a kidney.
Study design
The study is a proof-of-principle study with an extreme phenotype nested
case-control design. Identification of microRNAs in plasma and urine will be
conducted in a cohort of former living kidney donors. All former donors are
invited to standard post-donation control of their renal function, proteinuria,
and blood pressure, and weight. During the clinical visit there will be 24h
urine and blood of the participants to microRNA measure their profiles into fat
and thin non-progressors and progressors of microalbuminuria since donation.
Figure 1
Urinary albumin excretion (UAE)
> 0.3g / d at follow-up BMI
18.5-25 kg/m2 BMI> 27 kg/m2
Progressor overtime 20-25
extremes 20-25 extremes
Non-Progressor overtime 20-25
extremes 20-25 extremes
Study burden and risks
A very low risk, taking blood may involve some inconvenience,
Albinusdreef 2
Leiden 2333RC
NL
Albinusdreef 2
Leiden 2333RC
NL
Listed location countries
Age
Inclusion criteria
All former living kidney donors who donated a kidney since 1968 at the Leiden University Medical Center (aproximate n<=650).
Exclusion criteria
Patients will be excluded from analyses if their medical history or the oral glucose tolerance test (OGTT) at the day of assessment reveals presence of diabetes mellitus.
Design
Recruitment
metc-ldd@lumc.nl
Followed up by the following (possibly more current) registration
No registrations found.
Other (possibly less up-to-date) registrations in this register
No registrations found.
In other registers
| Register | ID |
|---|---|
| CCMO | NL39603.058.13 |