HypopituitarismNCT00139945
Ghrelin, Growth Hormone and Cortisol Interaction in Growth Hormone Deficient Patients
A study testing Human acylated ghrelin in people with Hypopituitarism, run by University of Aarhus at 1 site in Denmark.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 60 years
- Conditions the study is for
- Hypopituitarism
- What is being tested?
- Human acylated ghrelin
- How many people
- 8 participants
- Where
- 1 siteDenmark
- Study dates
- Oct 2005to Mar 2007
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 60 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- Age between 18 and 60 yrs.
- Verified hypopituitarism
- Unchanged substitution treatment through 3+ months
- Unchanged additional medical treatment
- Oral and written informed consent
Who cannot join
- Age below 18 or above 60 yrs.
- Diabetes mellitus
- body mass index > 30
- Fasting hypoglycemia
- Convulsions
- Allergy to trial products
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Effects of Acute Ghrelin Infusion to Growth Hormone Deficient Adults: Growth Hormone and Cortisol Interaction
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.
- Conditions
- Hypopituitarism
- Being tested
- Human acylated ghrelin
- Medical subject headings
- Hypopituitarism
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Human acylated ghrelinDrug
5 pmol/kg body weight per min
What is being measured
The primary outcome is the main question the study is designed to answer.
Endogenous serum ghrelin levels
Measured: Same day as intervention
Secondary outcomes (1)
Insulin sensitivity, appetite, metabolism, intracellular signal transduction
Measured: Same day as intervention
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 Aug 2005 (estimated)
- Study startOct 2005
- Primary completionMar 2007
- Study completionMar 2007
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for HypopituitarismStudies of the same condition, open and under way.
- More trials run by University of AarhusThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 8 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Aarhus
- Sponsor type
- University, hospital or other
- Investigators
- Jens Otto L Jorgensen, DrMedSci, Principal investigator, Aarhus University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00139945
- Sponsor's protocol ID
- 2004/102
- Status last verified
- Jan 2010
- First submitted
- 30 Aug 2005
- Last updated
- 20 Jan 2010
- Results posted
- No
- Data monitoring committee
- No
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 32975853Vestergaard 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
Study at a glance
From the registry record, last updated by the sponsor on 20 Jan 2010. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Acute Ghrelin Infusion to Growth Hormone Deficient Adults: Growth Hormone and Cortisol Interaction
- ClinicalTrials.gov ID
- NCT00139945
- Acronym / sponsor ID
- 2004/102
- Conditions
- Hypopituitarism
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 8 participants (actual)
- Lead sponsor
- University of AarhusUniversity, hospital or other
- Study start
- Oct 2005
- Primary completion
- Mar 2007 (actual)
- Study completion
- Mar 2007 (actual)
- First posted
- 31 Aug 2005 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- Age between 18 and 60 yrs.
- Verified hypopituitarism
- Unchanged substitution treatment through 3+ months
- Unchanged additional medical treatment
- Oral and written informed consent
Key exclusion criteria (6 listed)
- Age below 18 or above 60 yrs.
- Diabetes mellitus
- body mass index > 30
- Fasting hypoglycemia
- Convulsions
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Human acylated ghrelin5 pmol/kg body weight per min | Drug | – |
Primary outcome
Endogenous serum ghrelin levels
Time frame: Same day as intervention
1 secondary outcome
Insulin sensitivity, appetite, metabolism, intracellular signal transduction
Time frame: Same day as intervention
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Jan 2010.
- Derived from this study: PubMed 32975853Lauritzen 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.
- Derived from this study: PubMed 18776138Vestergaard 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.
Related trials for Hypopituitarism
RecruitingPhase 1
Effects of Intranasal Oxytocin in Patients With Arginine-vasopressin Deficiency
Vasopressin Deficiency
RecruitingEarly Phase 1
Identifying Oxytocin Deficiency in Pediatric Patients With Pituitary Disease
Arginine Vasopressin Deficiency, Oxytocin Deficiency
RecruitingPhase 3
Phase 3 Study of LUM-201 in Children With Growth Hormone Deficiency
Growth Hormone Deficiency (GHD)
RecruitingPhase 3
Growth Hormone Replacement Therapy in Veterans With Mild Traumatic Brain Injury (mTBI) and Adult Growth Hormone Deficiency (AGHD)
Adult Growth Hormone Deficiency, Mild Traumatic Brain Injury
Active, not recruitingObservational study
Ngenla Subcutaneous Injection Special Investigation
Growth Hormone Deficiency Without Epiphyseal Closure
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Jens Otto L Jorgensen, DrMedSci principal investigator
Aarhus University Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Human acylated ghrelin in people with Hypopituitarism, run by University of Aarhus at 1 site in Denmark.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 20 Jan 2010. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Denmark. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Endogenous serum ghrelin levels (time frame: Same day as intervention). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00139945, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 Jan 2010.