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CompletedNCT00139945Updated Jan 20, 2010

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

An interventional study of Human acylated ghrelin in Hypopituitarism, sponsored by University of Aarhus. Completed at 1 site in Denmark. Open to participants aged 18 Years to 60 Years. Per ClinicalTrials.gov, last updated 2010-01-20.

Sponsored by University of Aarhus · Not applicable, Interventional, and Treatment

Phase
Not applicable
Study type
Interventional
Enrollment
8
Allocation
Randomized
Ages
18 Years to 60 Years
Sex
All
01

Study 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.

02

Conditions studied

  • Hypopituitarism

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03

In context

Hypopituitarism

47 studies on the registry are indexed under Hypopituitarism; 8 are open to participants now.

This study's enrollment of 8 is below the median of 38 across 29 interventional studies indexed under Hypopituitarism.

Browse Hypopituitarism studies →

Lead sponsor

University of Aarhus is the lead sponsor of 1,300 studies on the registry; 189 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 60 Years
Sexes eligible
All
Accepts healthy volunteers
No

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

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

Exclusion criteria

Exclusion Criteria:

  • Age below 18 or above 60 yrs.
  • Diabetes mellitus
  • > 30
  • Fasting hypoglycemia
  • Convulsions
  • Allergy to trial products
Terms in these criteria, in plain language(2)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

Informed consent

Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.

You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.

BMI (body mass index)

Weight in kilograms divided by height in metres squared. Example: 70 kg and 1.75 m gives 70 ÷ (1.75 × 1.75) ≈ 22.9.

What counts as overweight or obesity differs between countries (some use lower cut-offs), so go by the range the study states.

05

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Crossover assignment
Masking
Quadruple (Participant, Care provider, Investigator, Outcomes assessor)
Enrollment
8 participants (actual)

Interventions

  • DrugHuman acylated ghrelin

    5 pmol/kg body weight per min

06

What researchers measure

Primary outcomes

  1. Endogenous serum ghrelin levels

    Time frame: Same day as intervention

Secondary outcomes

  1. Insulin sensitivity, appetite, metabolism, intracellular signal transduction

    Time frame: Same day as intervention

07

Study locations

1 site
  • Aarhus University Hospital
    Aarhus, 8000, Denmark
08

References and documents

Publications

  • 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. PubMed 32975853 ↗
  • 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. PubMed 18776138 ↗
09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jan 20, 2010, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT00139945
First posted
Aug 31, 2005
Start date
Oct 2005
Primary completion
Mar 2007
Completion
Mar 2007
Last update
Jan 20, 2010

Study contacts

Jens Otto L Jorgensen, DrMedSci
principal investigator · Aarhus University Hospital

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Jan 2010. You cannot join it, but the record below documents what was studied.

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Discussion

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