NCT01879137

Brief Summary

the purpose of the study is to investigate whether arginine infusion is a new tool to differentiate patients with diabetes insipidus, primary polydipsia and healthy subjects.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
60

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started Jun 2013

Longer than P75 for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

June 1, 2013

Completed
11 days until next milestone

First Submitted

Initial submission to the registry

June 12, 2013

Completed
5 days until next milestone

First Posted

Study publicly available on registry

June 17, 2013

Completed
3.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2017

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2017

Completed
Last Updated

July 11, 2017

Status Verified

July 1, 2017

Enrollment Period

3.9 years

First QC Date

June 12, 2013

Last Update Submit

July 10, 2017

Conditions

HealthyPolyuria-polydipsia Syndrome

Keywords

CopeptinArginin stimulation test

Outcome Measures

Primary Outcomes (1)

  • Discriminative value of copeptin after arginine infusion in the differential diagnosis of polyuria-polydipsia syndrome.

    up to 120 minutes after the Arginine infusion.

Study Arms (2)

healthy adults

Patients with a polyuria-polydipsia syndrome

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Healthy adults Patients with polyuria-polydipsia syndrome

You may qualify if:

  • Age over 18 years
  • No medication except hormonal contraception

You may not qualify if:

  • Evidence of any acute illness
  • Subjects refusing or unable to give written informed consent
  • Pregnancy
  • Any evidence of disordered drinking habits and diuresis

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University Hospital Basel

Basel, Canton of Basel-City, 4031, Switzerland

Location

Biospecimen

Serum EDTA

MeSH Terms

Conditions

Diabetes Insipidus

Condition Hierarchy (Ancestors)

Kidney DiseasesUrologic DiseasesFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesMale Urogenital DiseasesPituitary DiseasesEndocrine System Diseases

Study Officials

  • Mirjam Christ-Crain, Prof. MD

    University Hospital, Basel, Switzerland

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

June 12, 2013

First Posted

June 17, 2013

Study Start

June 1, 2013

Primary Completion

May 1, 2017

Study Completion

May 1, 2017

Last Updated

July 11, 2017

Record last verified: 2017-07

Locations

CH(1)