Peripheral Metabolic Effects of Ghrelin | NCT00771940

Studies
Peripheral Metabolic Effects of Ghrelin

NCT00771940

Sponsor

University of Aarhus

Status

Completed

Last Update Posted

Feb 3, 2009Estimated

Enrollment

8Estimated

Phase

Phase 1

Conditions

Healthy Controls

Interventions

Ghrelin

Countries

Denmark

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

Feb 2009

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

Oct 2008

Primary Completion Date

Jan 2009Actual

Completion Date

Jan 2009Actual

First Submitted Date

Oct 8, 2008

First Submission Date that Met QC Criteria

Oct 13, 2008

First Posted Date

Oct 15, 2008Estimated

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

Feb 2, 2009

Last Update Posted Date

Feb 3, 2009Estimated

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

The aim of this study is to investigate putative peripheral effects of ghrelin on glucose and lipid metabolism in healthy men. Eight subjects will be enrolled. The hypothesis is that ghrelin infusion causes insulin resistance and lipolysis.

Detailed Description

Not provided

Design Module

Study Type

Interventional

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

Phase 1

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

8Estimated

Label	Type	Description	Intervention Names
Ghrelin	Active Comparator		Drug: Ghrelin

Name	Type	Description	Arm Group Labels	Other Names
Ghrelin	Drug	Solvent, cont. infusion	Ghrelin

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Plasma levels of glucose		During study day

Secondary Outcomes

Measure	Description	Time Frame
Insulin signaling		Study day
Serum levels of fatty acids		Study day

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

BMI < 27 kg/m2
Written informed consent
Non-smoker

Exclusion Criteria:

Any disease including epilepsy
Any use of medications (excl. paracetamol)
Present or previous malignancy
Alcohol dependency
Allergy to any trial medication

Accepts Healthy Volunteers

Yes

Sex

Male

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

60 Years

Standard Ages

Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Jens Otto L. Jorgensen, MD	Medical Department M, Aarhus University Horpital, Denmark	Study Director
Esben T Vestergaard, PhD	Medical Department M, Aarhus University Hospital, Denmark	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Aarhus University Hospital		Aarhus		Dk-8000	Denmark

Intervention Browse Module

MeSH Terms

ID	Term
D054439	Ghrelin

Ancestor Terms

ID	Term
D036361	Peptide Hormones
D006728	Hormones
D006730	Hormones, Hormone Substitutes, and Hormone Antagonists
D010455	Peptides

Browse Leaves

Not provided

Browse Branches

Not provided