Whole Body Catabolisme Induced by GlucocorticoidsPhase 2NCT01762540
Glucocorticoid Induced Whole Body Catabolisme
A Phase 2 study testing Glucocorticoids and Calcium Supplement in people with Whole Body Catabolisme Induced by Glucocorticoids, run by University of Aarhus at 1 site in Denmark.
Trial summary
The main purpose of the trial is to advance our knowledge on the possible mechanism underlying the catabolic effects of long-term treatment with glucocorticoid. Read more about this study
- Who is it for?
- Ages 20 to 30 years, men onlyHealthy volunteers can take part
- Conditions the study is for
- Whole Body Catabolisme Induced by Glucocorticoids
- What is being tested?
- Glucocorticoids and Calcium Supplement
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 19 participants
- Where
- 1 siteDenmark
- Study dates
- Jan 2013to Jun 2014
- Phase
- Phase 2
- 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 20 to 30 years
- Men only
- Healthy volunteers accepted
- Adult
Who may be able to join
- signed and dated informed consent
- healthy subjects
- sex: male
- age 20-30 years
- BMI 19-26 kg/m2
- normal HbA1c
Who cannot join
- suspected og known allergy to the trial drug or similar medications.
- known current illness including diabetes mellitus, ischemic heart disease or cardiac arrhythmia.
- Daily drug intake (excluding Over-the-Counter medicines).
- Known or previous mental illness
- Current participation or previous participation in experiments using ionizing radiation for a year prior to inclusion in this study.
- Participation in a larger X-ray examinations in trial period.
Trial locations and contacts
1 site in 1 country.
Denmark1 site
Medical Research Laboratory, Clinical Institute of Medicine, Aarhus University Hospital
Aarhus, 8000
About this study
Official title: Glucocorticoid Induced Inhibition of IGF-I Activity: Exploring Underlying Mechanisms.
The main purpose of the trial is to advance our knowledge on the possible mechanism underlying the catabolic effects of long-term treatment with glucocorticoid.
Read the detailed description
Long-term treatment with glucocorticoid induces a general state of catabolism and increases insulin resistance. The underlying mechanisms are insufficiently characterized, however glucocorticoid induced changes of Growth Hormone (GH) and the Insulin-like growth factor I (IGF-I) appear to be of outmost importance.
We wish to investigate the mechanism behind glucocorticoid induced catabolism and insulin resistance.
More specific we wish to investigate:
- Whether glucocorticoid induces IGF-I inhibiting substances in serum or interstitial fluid that block the ability of IGF-I to phosphorylate its receptor in vitro
- Whether glucocorticoid inhibits intracellular IGF-I and insulin signaling in vitro and in vivo
- The mechanisms by which growth hormone counteracts the CG-mediated inhibition of IGF-I action
- Being tested
- Glucocorticoids, Calcium Supplement
- Keywords
- Protein breakdown, Insulin resistance, Glucose intolerance, Lipolysis
- Medical subject headings
- Insulin Resistance, Glucose Intolerance
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
GlucocorticoidsDrug
Also called Prednisolone
Prednisolone 37.5 mg x1 for 5 days
Calcium SupplementDrug
Also called Placebo
Placebo
| Study group | Role | What they receive |
|---|---|---|
| Calcium supplement | Placebo comparator | Capsule with tablet of calclium supplement Receives: Drug: Calcium Supplement |
| Glucocorticoids | Active comparator | Capsule with tablet of Prednisolone 37,5mg Receives: Drug: Glucocorticoids |
What is being measured
The primary outcome is the main question the study is designed to answer.
Insulin-like Growth Factor (IGF)-I profiles of subjects before and after prednisolone-treatment.
Blood-test before (day 1) during (day 3) and at the end (day 5) of placebo/prednisolone treatment.
Measured: day 1, 3 and 5
Secondary outcomes (2)
Intracellular signaling of IGF-I under the influence/abscence of prednisolone.
Tissue biopsy on day 5.
Measured: day 5
Insulin sensitivity under the influence/abscence of prednisolone.
Hyperinsulinemic euglycemic clamp on day 5.
Measured: Day 5
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Jan 2013 (estimated)
- Study startJan 2013
- Primary completionJun 2014
- Study completionJun 2014
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 Whole Body Catabolisme Induced by GlucocorticoidsStudies 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 2
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 19 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Aarhus
- Sponsor type
- University, hospital or other
- Collaborators
- The Ministry of Science, Technology and Innovation, Denmark
- Responsible party
- Sponsor
- Investigators
- Jan Frystyk, Professor, Principal investigator, Medical Research Laboratory, Clinical institute of Medicine, Aarhus University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01762540
- Sponsor's protocol ID
- GK_nilani_2012
- Status last verified
- Jan 2013
- First submitted
- 3 Jan 2013
- Last updated
- 8 Jan 2016
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Ramshanker N, Jessen N, Voss TS, Pedersen SB, Jorgensen JOL, Nielsen TS, Frystyk J, Moller N. Effects of short-term prednisolone treatment on indices of lipolysis and lipase signaling in abdominal adipose tissue in healthy humans. Metabolism. 2019 Oct;99:1-10. doi: 10.1016/j.metabol.2019.06.013. Epub 2019 Jun 29.
PubMed 31260678Ramshanker N, Aagaard M, Hjortebjerg R, Voss TS, Moller N, Jorgensen JOL, Jessen N, Bjerring P, Magnusson NE, Bjerre M, Oxvig C, Frystyk J. Effects of Prednisolone on Serum and Tissue Fluid IGF-I Receptor Activation and Post-Receptor Signaling in Humans. J Clin Endocrinol Metab. 2017 Nov 1;102(11):4031-4040. doi: 10.1210/jc.2017-00696.
PubMed 28945869
Study at a glance
From the registry record, last updated by the sponsor on 8 Jan 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Glucocorticoid Induced Inhibition of IGF-I Activity: Exploring Underlying Mechanisms.
- ClinicalTrials.gov ID
- NCT01762540
- Acronym / sponsor ID
- GK_nilani_2012
- Keywords
- Protein breakdown, Insulin resistance, Glucose intolerance, Lipolysis
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 19 participants (actual)
- Lead sponsor
- University of AarhusUniversity, hospital or other
- Collaborators
- The Ministry of Science, Technology and Innovation, Denmark
- Study start
- Jan 2013
- Primary completion
- Jun 2014 (actual)
- Study completion
- Jun 2014 (actual)
- First posted
- 7 Jan 2013 (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.
The main purpose of the trial is to advance our knowledge on the possible mechanism underlying the catabolic effects of long-term treatment with glucocorticoid.
Detailed description
Long-term treatment with glucocorticoid induces a general state of catabolism and increases insulin resistance. The underlying mechanisms are insufficiently characterized, however glucocorticoid induced changes of Growth Hormone (GH) and the Insulin-like growth factor I (IGF-I) appear to be of outmost importance.
We wish to investigate the mechanism behind glucocorticoid induced catabolism and insulin resistance.
More specific we wish to investigate:
- Whether glucocorticoid induces IGF-I inhibiting substances in serum or interstitial fluid that block the ability of IGF-I to phosphorylate its receptor in vitro
- Whether glucocorticoid inhibits intracellular IGF-I and insulin signaling in vitro and in vivo
- The mechanisms by which growth hormone counteracts the CG-mediated inhibition of IGF-I action
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Calcium supplement | Placebo comparator | Drug: Calcium SupplementCapsule with tablet of calclium supplement |
| Glucocorticoids | Active comparator | Drug: GlucocorticoidsCapsule with tablet of Prednisolone 37,5mg |
Who may qualify
- Ages
- 20 to 30 years
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (6 listed)
- signed and dated informed consent
- healthy subjects
- sex: male
- age 20-30 years
- BMI 19-26 kg/m2
Key exclusion criteria (6 listed)
- suspected og known allergy to the trial drug or similar medications.
- known current illness including diabetes mellitus, ischemic heart disease or cardiac arrhythmia.
- Daily drug intake (excluding Over-the-Counter medicines).
- Known or previous mental illness
- Current participation or previous participation in experiments using ionizing radiation for a year prior to inclusion in this study.
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 |
|---|---|---|
| GlucocorticoidsAlso: PrednisolonePrednisolone 37.5 mg x1 for 5 days | Drug | Glucocorticoids |
| Calcium SupplementAlso: PlaceboPlacebo | Drug | Calcium supplement |
Primary outcome
Insulin-like Growth Factor (IGF)-I profiles of subjects before and after prednisolone-treatment.
Time frame: day 1, 3 and 5
Blood-test before (day 1) during (day 3) and at the end (day 5) of placebo/prednisolone treatment.
2 secondary outcomes
Intracellular signaling of IGF-I under the influence/abscence of prednisolone.
Time frame: day 5
Insulin sensitivity under the influence/abscence of prednisolone.
Time frame: Day 5
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 8 Jan 2016.
- Derived from this study: PubMed 31260678Ramshanker N, Jessen N, Voss TS, Pedersen SB, Jorgensen JOL, Nielsen TS, Frystyk J, Moller N. Effects of short-term prednisolone treatment on indices of lipolysis and lipase signaling in abdominal adipose tissue in healthy humans. Metabolism. 2019 Oct;99:1-10. doi: 10.1016/j.metabol.2019.06.013. Epub 2019 Jun 29.
- Derived from this study: PubMed 28945869Ramshanker N, Aagaard M, Hjortebjerg R, Voss TS, Moller N, Jorgensen JOL, Jessen N, Bjerring P, Magnusson NE, Bjerre M, Oxvig C, Frystyk J. Effects of Prednisolone on Serum and Tissue Fluid IGF-I Receptor Activation and Post-Receptor Signaling in Humans. J Clin Endocrinol Metab. 2017 Nov 1;102(11):4031-4040. doi: 10.1210/jc.2017-00696.
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.
Jan Frystyk, Professor principal investigator
Medical Research Laboratory, Clinical institute of Medicine, 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 Phase 2 study testing Glucocorticoids and Calcium Supplement in people with Whole Body Catabolisme Induced by Glucocorticoids, 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 6 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 8 Jan 2016. 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. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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?
Insulin-like Growth Factor (IGF)-I profiles of subjects before and after prednisolone-treatment. (time frame: day 1, 3 and 5). 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 NCT01762540, 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 8 Jan 2016.