Ignite Creation Date:
2024-10-26 @ 3:37 PM
Last Modification Date:
2024-10-26 @ 3:37 PM
Study NCT ID:
NCT06542198
Status:
NOT_YET_RECRUITING
Last Update Posted:
None
First Post:
2024-07-26
Brief Title:
Mannitol-induced Release of Copeptin in Healthy Adults and Patients With Polyuria-Polydipsia Syndrome MARS Study
Sponsor:
None
Organization:
None
Study Overview
Official Title:
Mannitol-induced Release of Copeptin in Healthy Adults and Patients With Polyuria-Polydipsia Syndrome a Double-blind Randomized Crossover Proof-of-concept and Open-label Single Arm Pilot Study MARS Study
Status:
NOT_YET_RECRUITING
Status Verified Date:
2024-08
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
No
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
The aims of this study are to investigate whether mannitol stimulates copeptin part 1 proof-of-concept and whether the copeptin levels upon mannitol infusion differ in primary polydipsia and arginine vasopressin deficiency part 2 pilot study
Detailed Description:
Diagnosing polyuria-polydipsia syndrome which includes arginine vasopressin AVP deficiency AVP-D formerly central diabetes insipidus and primary polydipsia PP is challenging but essential Currently the most accurate test currently involves measuring copeptin after osmotic stimulation with hypertonic saline but this test is rarely used due to the need for close sodium monitoring and the discomfort it can cause
Mannitol has been shown to stimulate AVP release but no study has tested copeptin levels after mannitol stimulation in healthy adults or patients with AVP-D or PP
This single-center study is conducted in two consecutive parts Part 1 is a double-blind randomized cross-over proof-of-concept study in healthy adults to investigate if mannitol infusion stimulates copeptin release Part 2 is an open-label single arm case-control pilot study in adults with diagnosed PP or AVP-D to see if copeptin levels after mannitol stimulation differ in PP and AVP-D
The results of this study aim to demonstrate if mannitol infusion has the potential to be used as an alternative to hypertonic saline infusion
Mannitol has been shown to stimulate AVP release but no study has tested copeptin levels after mannitol stimulation in healthy adults or patients with AVP-D or PP
This single-center study is conducted in two consecutive parts Part 1 is a double-blind randomized cross-over proof-of-concept study in healthy adults to investigate if mannitol infusion stimulates copeptin release Part 2 is an open-label single arm case-control pilot study in adults with diagnosed PP or AVP-D to see if copeptin levels after mannitol stimulation differ in PP and AVP-D
The results of this study aim to demonstrate if mannitol infusion has the potential to be used as an alternative to hypertonic saline infusion
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None