Ghrelin, Growth Hormone and Cortisol Interaction in Growt... | NCT00139945

Studies
Ghrelin, Growth Hormone and Cortisol Interaction in Growth Hormone Deficient Patients

NCT00139945

Sponsor

University of Aarhus

Status

Completed

Last Update Posted

Jan 20, 2010Estimated

Enrollment

8Actual

Phase

Not Applicable

Conditions

Hypopituitarism

Interventions

Human acylated 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

Jan 2010

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 2005

Primary Completion Date

Mar 2007Actual

Completion Date

Mar 2007Actual

First Submitted Date

Aug 30, 2005

First Submission Date that Met QC Criteria

Aug 30, 2005

First Posted Date

Aug 31, 2005Estimated

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

Jan 19, 2010

Last Update Posted Date

Jan 20, 2010Estimated

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

In growth hormone deficient patients: Determination of endogenous circulating ghrelin levels, ghrelin effects on insulin sensitivity, appetite, energy metabolism, and signal transduction in fat and muscle.

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

Not Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

8Actual

Name	Type	Description	Arm Group Labels	Other Names
Human acylated ghrelin	Drug	5 pmol/kg body weight per min

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Endogenous serum ghrelin levels		Same day as intervention

Secondary Outcomes

Measure	Description	Time Frame
Insulin sensitivity, appetite, metabolism, intracellular signal transduction		Same day as intervention

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Age between 18 and 60 yrs.
Verified hypopituitarism
Unchanged substitution treatment through 3+ months
Unchanged additional medical treatment
Oral and written informed consent

Exclusion Criteria:

Age below 18 or above 60 yrs.
Diabetes mellitus
body mass index > 30
Fasting hypoglycemia
Convulsions
Allergy to trial products

Accepts Healthy Volunteers

Sex

All

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, DrMedSci	Aarhus University Hospital	Principal Investigator

Locations

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

References Module

Citations

PubMed Identifier	Type	Citation	Retractions
32975853	Derived	Lauritzen ES, Jorgensen JOL, Moller N, Nielsen S, Vestergaard ET. Increased lipolysis after infusion of acylated ghrelin: a randomized, double-blinded placebo-controlled trial in hypopituitary patients. Clin Endocrinol (Oxf). 2020 Dec;93(6):672-677. doi: 10.1111/cen.14290. Epub 2020 Aug 3.
18776138	Derived

ID	Term
D010900	Pituitary Diseases
D007027	Hypothalamic Diseases
D001927	Brain Diseases
D002493	Central Nervous System Diseases