NCT01303848

Brief Summary

To elucidate whether blood lactate, lipid transfer proteins and PPARs/CLOCK/Bal1 have a circadian rhythm

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 2011

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

February 1, 2011

Completed
23 days until next milestone

First Submitted

Initial submission to the registry

February 24, 2011

Completed
1 day until next milestone

First Posted

Study publicly available on registry

February 25, 2011

Completed
9 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2011

Completed
5 months until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2012

Completed
Last Updated

May 2, 2012

Status Verified

May 1, 2012

Enrollment Period

10 months

First QC Date

February 24, 2011

Last Update Submit

May 1, 2012

Conditions

Healthy

Keywords

Blood lactateLipid transfer proteinsLactatePLTPCETPPPARsCLOCkBal1

Outcome Measures

Primary Outcomes (1)

  • Circadian rhythm of blood lactate

    Blood samples

    5 months

Secondary Outcomes (2)

  • Circadian rhythm of Lipid transfer proteins

    5 months

  • Circadian rhythm of PPARs, CLOCK and Bal1

    5 months

Study Arms (1)

Healthy probands

Healthy probands, age between 18 and 40 years

Other: Blood Sampling

Interventions

Blood SamplingOTHER

Blood Sampling over 24 hours

Healthy probands

Eligibility Criteria

Age18 Years - 40 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)
Sampling MethodNon-Probability Sample
Study Population

30 healthy probands

You may qualify if:

  • Age between 18 and 40 years old

You may not qualify if:

  • Inability/unwilling to give written informed consent
  • Chronic disease

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University Clinic Halle, Martin Luther-University Halle-Wittenberg

Halle, 06120, Germany

Location

MeSH Terms

Interventions

Blood Specimen Collection

Intervention Hierarchy (Ancestors)

Specimen HandlingClinical Laboratory TechniquesDiagnostic Techniques and ProceduresDiagnosisPuncturesSurgical Procedures, OperativeInvestigative Techniques

Study Officials

  • Axel Schlitt, MD

    Department of Medicine III, University Clinic Halle, Martin Luther-University Halle-Wittenberg

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
PD Dr. med. habil.

Study Record Dates

First Submitted

February 24, 2011

First Posted

February 25, 2011

Study Start

February 1, 2011

Primary Completion

December 1, 2011

Study Completion

May 1, 2012

Last Updated

May 2, 2012

Record last verified: 2012-05

Locations

DE(1)