Circadian Rhythm of Blood Lactate | NCT01303848

Studies
Circadian Rhythm of Blood Lactate

NCT01303848

Sponsor

Martin-Luther-Universität Halle-Wittenberg

Status

Completed

Last Update Posted

May 2, 2012Estimated

Enrollment

30Actual

Phase

Not provided

Conditions

Healthy

Interventions

Blood Sampling

Countries

Germany

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

May 2012

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Feb 2011

Primary Completion Date

Dec 2011Actual

Completion Date

May 2012Actual

First Submitted Date

Feb 24, 2011

First Submission Date that Met QC Criteria

Feb 24, 2011

First Posted Date

Feb 25, 2011Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

May 1, 2012

Last Update Posted Date

May 2, 2012Estimated

Sponsor/Collaborators Module

Responsible Party, by Official Title

Axel Schlitt, PD Dr. med. habil., Martin-Luther-Universität Halle-WittenbergPrincipal Investigator

Lead Sponsor

Martin-Luther-Universität Halle-WittenbergOTHER

Collaborators

Name	Class
State University of New York - Downstate Medical Center	OTHER

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief Summary

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

Detailed Description

Blood will be drawn fasting and then every hour over a period of 24 hours in 30 healthy probands.

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

30Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Healthy probands		Healthy probands, age between 18 and 40 years	Other: Blood Sampling

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Blood Sampling	Other	Blood Sampling over 24 hours	Healthy probands

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Circadian rhythm of blood lactate	Blood samples	5 months

Secondary Outcomes

Measure	Description	Time Frame
Circadian rhythm of Lipid transfer proteins	Blood	5 months
Circadian rhythm of PPARs, CLOCK and Bal1	Blood	5 months

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Age between 18 and 40 years old

Exclusion Criteria:

Inability/unwilling to give written informed consent
Chronic disease

Accepts Healthy Volunteers

Yes

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

40 Years

Standard Ages

Adult

Study Population

30 healthy probands

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Axel Schlitt, MD	Department of Medicine III, University Clinic Halle, Martin Luther-University Halle-Wittenberg	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
University Clinic Halle, Martin Luther-University Halle-Wittenberg		Halle		06120	Germany

Intervention Browse Module

MeSH Terms

ID	Term
D001800	Blood Specimen Collection

Ancestor Terms

ID	Term
D013048	Specimen Handling
D019411	Clinical Laboratory Techniques
D019937	Diagnostic Techniques and Procedures
D003933	Diagnosis

Browse Leaves

Not provided

Browse Branches

Not provided