To study the extent of impaired urinary concentrating ability in hypothyroidism as well as the pathophysiological mechanisms involved before and after adequate treatment.
ID
Source
Brief title
Condition
- Thyroid gland disorders
- Renal disorders (excl nephropathies)
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
The primary outcome will be a significant difference in maximal urine
osmolality after water deprivation in euthyroid and hypothyroid state.
Secondary outcome
The secondary outcome is a difference in heart rate, urinary water and salt
transporter excretion in urinary microvesicles (both protein and RNA abundance)
and vasopressin/ copeptin levels after water deprivation.
Background summary
Hypothyroidism is associated with impaired urinary concentrating ability. The
effect of treatment as well as the mechanism involved have not been adequately
studied in humans.
Study objective
To study the extent of impaired urinary concentrating ability in hypothyroidism
as well as the pathophysiological mechanisms involved before and after adequate
treatment.
Study design
Single centre intervention study. During regular clinical follow-up, patients
with differentiated thyroid cancer are subject to severe hypothyroidism before
I-131 therapy, whereas they have relatively normal thyroid hormone levels
before thyroidectomy and after I-131 therapy when receiving thyroid hormone
substitution therapy with levothyroxine. Therefore, these patients provide an
excellent model to study the consequences of variations in thyroid state.
During two regular clinical visits, patients will undergo a water deprivation
test as well as blood and urine analysis.
Intervention
14 hour fasting.
Study burden and risks
Serum will be obtained by collecting two additional tubes of blood when blood
is drawn as part of the regular clinical follow-up. Also, one spot urine
sample will be collected.
An overnight water deprivation test will be performed, which may be
inconvenient for the patient. The risk of fasting includes dehydration and
related symptoms, such as excessive thirst, change in mental state and decrease
of blood pressure. However, the risk of dehydration after 14 hour fasting is
negligible.
There are no direct benefits associated with participation for the individual
patients.
's-Gravendijkwal 230
Rotterdam 3015 CE
NL
's-Gravendijkwal 230
Rotterdam 3015 CE
NL
Listed location countries
Age
Inclusion criteria
patient with differentiated thyroid carcinoma
Have the capacity to understand and willingness to sign an informed consent form.
Aged 18-65 years
Estimated kidney function, eGFR >60 mL/min per 1.73 m2
Exclusion criteria
Alcohol abuse
Other malignancy
Clinically relevant active systemic disease (such as autoimmune or infectious diseases)
Pregnancy
Use of drugs interfering with thyroid hormone metabolism (e.g. antiepileptic drugs, amiodarone, and lithium) or influencing renal concentration capacity (i.e. diuretics)
Other primary thyroid disease
History of diabetes insipidus, diabetes mellitus, adrenal deficiency, chronic kidney disease
Urinary tract infection or menstruation at the time of inclusion
Design
Recruitment
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 | NL48144.078.14 |