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

NCT ID: NCT00139945

Last Updated: 2010-01-20

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

8 participants

Study Classification

INTERVENTIONAL

Study Start Date

2005-10-31

Study Completion Date

2007-03-31

Brief Summary

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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

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Conditions

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Hypopituitarism

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Primary Study Purpose

TREATMENT

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Interventions

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Human acylated ghrelin

5 pmol/kg body weight per min

Intervention Type DRUG

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

60 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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University of Aarhus

OTHER

Sponsor Role lead

Responsible Party

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University of Aarhus

Principal Investigators

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Jens Otto L Jorgensen, DrMedSci

Role: PRINCIPAL_INVESTIGATOR

Aarhus University Hospital

Locations

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Aarhus University Hospital

Aarhus, , Denmark

Site Status

Countries

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Denmark

References

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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.

Reference Type DERIVED
PMID: 32975853 (View on PubMed)

Vestergaard ET, Gormsen LC, Jessen N, Lund S, Hansen TK, Moller N, Jorgensen JO. Ghrelin infusion in humans induces acute insulin resistance and lipolysis independent of growth hormone signaling. Diabetes. 2008 Dec;57(12):3205-10. doi: 10.2337/db08-0025. Epub 2008 Sep 5.

Reference Type DERIVED
PMID: 18776138 (View on PubMed)

Other Identifiers

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2004/102

Identifier Type: -

Identifier Source: org_study_id

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