The development of a thirst provocation test using the AVP receptor antagonist Tolvaptan for quantification of thirst sensation in various patient groups (obese patients with and without a history of bariatric surgery, patients with congestive heart failure and patients with cranial diabetes insipidus as compared to healthy controls) and genotyping of the AVP receptor 2.
- Conditions
- abnormal thirstpathological thirst sensation100192801002111210017998
- Registration Number
- NL-OMON38159
- Lead Sponsor
- Reinier de Graaf Groep
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Withdrawn
- Sex
- Not specified
- Target Recruitment
- 60
1. Informed consent signed by all healthy probands and patients
2. Male and female probands and patients, age 18 - 65 years
3. For obese patients with a history of Bariatric Surgery: Pre-BS BMI >27 Kg/m2
4. For obese patients without a history of BS: BMI >27 Kg/m2
5. For obese patients with a history of BS: operation at least 2 years ago, stable weight for at least a year
1. Unwillingness to cooperate with the study procedures
2. History of an active malignancy
3. No written informed consent
4. Pregnancy
5. Breastfeeding
6. Urinary tract obstruction like benign prostate hyperplasia, or patients otherwise unable to void
7. (A history of) electrolyte disturbances or renal failure
8. Diabetes mellitus (as this can cause pseudohyponatraemia)
9. Lactose- or galactose intolerance
10. Clinical signs of dehydration
11. Failure to meet the inclusion criteria
Study & Design
- Study Type
- Observational invasive
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method <p>The main objective of this study is to determine the effects of BS, heart<br /><br>failure and diabetes insipidus on thirst sensation as measured on a visual<br /><br>analogue scale (VAS).</p><br>
- Secondary Outcome Measures
Name Time Method <p>The secondary objectives of this study are to determine the relation between<br /><br>AVP2R genotype and thirst sensation.</p><br>