NCT01772914

Brief Summary

The purpose of this study is to determine whether copeptin levels are affected by food intake.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
30

participants targeted

Target at below P25 for all trials

Timeline
Completed

Started Feb 2013

Shorter than P25 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

First Submitted

Initial submission to the registry

January 17, 2013

Completed
4 days until next milestone

First Posted

Study publicly available on registry

January 21, 2013

Completed
11 days until next milestone

Study Start

First participant enrolled

February 1, 2013

Completed
4 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2013

Completed
8 months until next milestone

Study Completion

Last participant's last visit for all outcomes

February 1, 2014

Completed
Last Updated

May 20, 2014

Status Verified

January 1, 2013

Enrollment Period

4 months

First QC Date

January 17, 2013

Last Update Submit

May 19, 2014

Conditions

Healthy AdultsCopeptin

Keywords

Copeptineatingglucose tolerance testmixed meal testphysiological

Outcome Measures

Primary Outcomes (1)

  • Changes in copeptin levels after intake of a oral glucose tolerance test- and a mixed meal tolerance test liquid

    30, 60, 90, 120, 180 minutes after intake of the test liquids

Eligibility Criteria

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

healthy adults

You may qualify if:

  • Aged over 18 years

You may not qualify if:

  • Intake of any kind of medication (except birth control pill)
  • BMI \>30 kg/m2
  • Evidence of any acute illness
  • History of chronic illness
  • Pregnancy
  • Known galactosemia or maltose malabsorption
  • Baseline glucose level \>5.5 mmol/l Baseline sodium level \<135 mmol/l or \>145 mmol/l

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University Hospital Basel

Basel, Canton of Basel-City, 4031, Switzerland

Location

Related Publications (1)

  • Walti C, Siegenthaler J, Christ-Crain M. Copeptin levels are independent of ingested nutrient type after standardised meal administration--the CoMEAL study. Biomarkers. 2014 Nov;19(7):557-62. doi: 10.3109/1354750X.2014.940504. Epub 2014 Sep 16.

    PMID: 25224842DERIVED

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.Dr.med.

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
CASE ONLY
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Prof. Dr. med.

Study Record Dates

First Submitted

January 17, 2013

First Posted

January 21, 2013

Study Start

February 1, 2013

Primary Completion

June 1, 2013

Study Completion

February 1, 2014

Last Updated

May 20, 2014

Record last verified: 2013-01

Locations

CH(1)