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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.

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. - Tolvaptan Thirst Research Project (TTReP)

Status
Unknown
Phases
Unknown
Study type
Observational
Source
NL-OMON
Registry ID
NL-OMON38159
Enrollment
60
Registered
2012-06-14
Start date
Unknown
Completion date
Unknown
Last updated
2024-04-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

abnormal thirst pathological thirst sensation

Interventions

None

Sponsors

Reinier de Graaf Groep
Lead Sponsor

Eligibility

Age
18 Years to 99 Years

Inclusion criteria

Inclusion criteria: 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

Exclusion criteria

Exclusion criteria: 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

Design outcomes

Primary

MeasureTime frame
The main objective of this study is to determine the effects of BS, heart failure and diabetes insipidus on thirst sensation as measured on a visual analogue scale (VAS).—

Secondary

MeasureTime frame
The secondary objectives of this study are to determine the relation between AVP2R genotype and thirst sensation.—

Countries

Netherlands

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP)