HealthyPhase 4NCT00709839
Rapid Effects of Hydrocortisone on Glucose-induced Insulin Secretion in Healthy Humans
A Phase 4 study testing Hydrocortisone and Glucose 33% in people with Healthy, run by Medical University of Vienna at 1 site in Austria.
Trial summary
The purpose of this study is to investigate the effect of hydrocortisone on glucose-induced insulin secretion and sensitivity, by means of an intravenous glucose tolerance test with frequent sampling (FSIGT) followed by minimal model analysis. Read more about this study
- Who is it for?
- Ages 18 to 60 years, men onlyHealthy volunteers can take part
- Conditions the study is for
- Healthy
- What is being tested?
- Hydrocortisone and Glucose 33%
- Type of treatment
- Injection or infusion
- How many people
- 10 participants
- Where
- 1 siteAustria
- Study dates
- Jun 2008to Dec 2008
- Phase
- Phase 4
- 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
- Men only
- Healthy volunteers accepted
- Adult
Who may be able to join
- Healthy subjects
- No concomitant medication
- BMI < 25 kg/m2
- Age: 18-60 years old
Who cannot join
- Impaired glucose tolerance or diabetes mellitus
- Hyperthyroidism, hypothyroidism
- Hepatic, renal or cardiovascular diseases
- Malignancies
- History of medical therapy within 3 weeks prior to enrolment into the study
Trial locations and contacts
1 site in 1 country.
Austria1 site
Division of Endocrinology and Metabolism, Department of Medicine III, Medical University of Vienna
Vienna, A-1090
About this study
The purpose of this study is to investigate the effect of hydrocortisone on glucose-induced insulin secretion and sensitivity, by means of an intravenous glucose tolerance test with frequent sampling (FSIGT) followed by minimal model analysis. In a randomized single-blind cross-over design, the subjects will receive either hydrocortisone or placebo 4 minutes before an intravenous glucose load.
Read the detailed description
Glucocorticoids (mainly cortisol in men and corticosterone in rodents) are secreted in the adrenal cortex under the control of the hypothalamic-pituitary-adrenal (HPA) axis. They are known for and named after their combined actions on glucose metabolism: suppression of insulin secretion, inhibition of glucose uptake in peripheral tissues, and promotion of gluconeogenesis in the liver. As a result, glucose intolerance accompanies syndromes of cortisol excess, while recurrent hypoglycemia, especially in response to stress, is a typical feature of isolated familial glucocorticoid deficiency. Almost any acute severe challenge to homeostasis or stress will activate the hypothalamic-pituitary-adrenal (HPA) axis and cause a rise in plasma glucocorticoid levels, which is essential for survival. Thanks to their immunosuppressive and antiinflammatory actions, glucocorticoids are widely-used therapeuticals with important adverse effects.
The need to optimize the benefit-risk ratio of glucocorticoid therapy has lead to a recent focus of research in the pathways mediating their effects. Glucocorticoids act rapidly and within minutes, exerting effects which contradict the classical genomic signalling pathway. Little is known on the clinical rapid effects of glucocorticoids on carbohydrate metabolism. Corticosterone acutely lowers insulin plasma concentrations and their response to hyperglycemia in rodents in vivo. Intraperitoneally administered hydrocortisone suppresses the insulin levels stimulated by intravenous glucose in mice. Although subject to numerous studies, the metabolic effects of glucocorticoids have been generally tested after giving dexamethasone for a few days.
To our knowledge, there are no data on rapid effects of glucocorticoids on insulin secretion and sensitivity in humans. Despite the increased interest in rapid effects of steroids in the last decade, the immediate effects of glucocorticoids on carbohydrate metabolism have not yet been studied. This question is not easy to address in vivo because of the multiple (also compensatory) influences that can impact the endocrine pancreas. Therefore, we propose to use a rapid approach, studying the effect of a bolus of hydrocortisone on the response to an intravenous glucose tolerance test with frequent sampling (FSIGT).
The FSIGT consists in giving intravenously a glucose bolus and taking frequently blood samples afterwards for determining glucose, insulin and C-peptide. The glucose and insulin data analysed with the minimal model technique allow the calculation of the acute insulin response, glucose effectiveness and the insulin sensitivity index. The data on C-peptide will be used to evaluate the beta cell function.
The effects of Hydrocortisone on glucose-induced insulin secretion and sensitivity will be investigated by means of an FSIGT followed by minimal model analysis. The subjects will receive in a randomized single-blind cross-over design:
- 0.6 mg/kg body wt Hydrocortisone + 330 mg/kg body wt glucose
- Placebo + 330 mg/kg body wt glucose
- Conditions
- Healthy
- Being tested
- Hydrocortisone, Glucose 33%
- Keywords
- glucocorticoid, hydrocortisone, carbohydrate metabolism, appetite-regulatory hormones
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
HydrocortisoneDrug
0.6 mg/kg body weight, intravenous bolus given at time-point minus 4'
Glucose 33%Drug
1ml/kg body weight, intravenous bolus given at time-point 0'
What is being measured
The primary outcome is the main question the study is designed to answer.
Plasma insulin, glucose and C-peptide
Measured: Minutes: -10, -5, 0, 3, 4, 5, 6, 8, 10, 15, 20, 30, 40, 60, 80, 100, 120, 150, 180
Secondary outcomes (1)
Plasma levels of appetite-regulatory hormones: ghrelin, PYY and nesfatin-1.
Measured: Minutes: -10, 0, 30, 60, 120, 180
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Jul 2008 (estimated)
- Study startJun 2008
- Primary completionOct 2008
- Study completionDec 2008
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for HealthyStudies of the same condition, open and under way.
- More trials run by Medical University of ViennaThe 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 4
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 10 participants (actual)
Sponsor and investigators
- Lead sponsor
- Medical University of Vienna
- Sponsor type
- University, hospital or other
- Investigators
- Anton Luger, MD, Principal investigator, Medical University of Vienna
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00709839
- Sponsor's protocol ID
- FSIGT_Hydrocortisone_01
- Status last verified
- Jan 2009
- First submitted
- 1 Jul 2008
- Last updated
- 1 Jun 2011
- Results posted
- No
- Data monitoring committee
- No
Publications
Vila G, Krebs M, Riedl M, Baumgartner-Parzer SM, Clodi M, Maier C, Pacini G, Luger A. Acute effects of hydrocortisone on the metabolic response to a glucose load: increase in the first-phase insulin secretion. Eur J Endocrinol. 2010 Aug;163(2):225-31. doi: 10.1530/EJE-10-0282. Epub 2010 May 18.
PubMed 20484150
Study at a glance
From the registry record, last updated by the sponsor on 1 Jun 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Rapid Effects of Hydrocortisone on Glucose-induced Insulin Secretion in Healthy Humans
- ClinicalTrials.gov ID
- NCT00709839
- Acronym / sponsor ID
- FSIGT_Hydrocortisone_01
- Conditions
- Healthy
- Keywords
- glucocorticoid, hydrocortisone, carbohydrate metabolism, appetite-regulatory hormones
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 10 participants (actual)
- Lead sponsor
- Medical University of ViennaUniversity, hospital or other
- Study start
- Jun 2008
- Primary completion
- Oct 2008 (actual)
- Study completion
- Dec 2008 (actual)
- First posted
- 3 Jul 2008 (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 purpose of this study is to investigate the effect of hydrocortisone on glucose-induced insulin secretion and sensitivity, by means of an intravenous glucose tolerance test with frequent sampling (FSIGT) followed by minimal model analysis. In a randomized single-blind cross-over design, the subjects will receive either hydrocortisone or placebo 4 minutes before an intravenous glucose load.
Detailed description
Glucocorticoids (mainly cortisol in men and corticosterone in rodents) are secreted in the adrenal cortex under the control of the hypothalamic-pituitary-adrenal (HPA) axis. They are known for and named after their combined actions on glucose metabolism: suppression of insulin secretion, inhibition of glucose uptake in peripheral tissues, and promotion of gluconeogenesis in the liver. As a result, glucose intolerance accompanies syndromes of cortisol excess, while recurrent hypoglycemia, especially in response to stress, is a typical feature of isolated familial glucocorticoid deficiency. Almost any acute severe challenge to homeostasis or stress will activate the hypothalamic-pituitary-adrenal (HPA) axis and cause a rise in plasma glucocorticoid levels, which is essential for survival. Thanks to their immunosuppressive and antiinflammatory actions, glucocorticoids are widely-used therapeuticals with important adverse effects.
The need to optimize the benefit-risk ratio of glucocorticoid therapy has lead to a recent focus of research in the pathways mediating their effects. Glucocorticoids act rapidly and within minutes, exerting effects which contradict the classical genomic signalling pathway. Little is known on the clinical rapid effects of glucocorticoids on carbohydrate metabolism. Corticosterone acutely lowers insulin plasma concentrations and their response to hyperglycemia in rodents in vivo. Intraperitoneally administered hydrocortisone suppresses the insulin levels stimulated by intravenous glucose in mice. Although subject to numerous studies, the metabolic effects of glucocorticoids have been generally tested after giving dexamethasone for a few days.
To our knowledge, there are no data on rapid effects of glucocorticoids on insulin secretion and sensitivity in humans. Despite the increased interest in rapid effects of steroids in the last decade, the immediate effects of glucocorticoids on carbohydrate metabolism have not yet been studied. This question is not easy to address in vivo because of the multiple (also compensatory) influences that can impact the endocrine pancreas. Therefore, we propose to use a rapid approach, studying the effect of a bolus of hydrocortisone on the response to an intravenous glucose tolerance test with frequent sampling (FSIGT).
The FSIGT consists in giving intravenously a glucose bolus and taking frequently blood samples afterwards for determining glucose, insulin and C-peptide. The glucose and insulin data analysed with the minimal model technique allow the calculation of the acute insulin response, glucose effectiveness and the insulin sensitivity index. The data on C-peptide will be used to evaluate the beta cell function.
The effects of Hydrocortisone on glucose-induced insulin secretion and sensitivity will be investigated by means of an FSIGT followed by minimal model analysis. The subjects will receive in a randomized single-blind cross-over design:
- 0.6 mg/kg body wt Hydrocortisone + 330 mg/kg body wt glucose
- Placebo + 330 mg/kg body wt glucose
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Single blind (participant)
Who may qualify
- Ages
- 18 to 60 years
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- Healthy subjects
- No concomitant medication
- BMI < 25 kg/m2
- Age: 18-60 years old
Key exclusion criteria (5 listed)
- Impaired glucose tolerance or diabetes mellitus
- Hyperthyroidism, hypothyroidism
- Hepatic, renal or cardiovascular diseases
- Malignancies
- History of medical therapy within 3 weeks prior to enrolment into the 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 |
|---|---|---|
| Hydrocortisone0.6 mg/kg body weight, intravenous bolus given at time-point minus 4' | Drug | – |
| Glucose 33%1ml/kg body weight, intravenous bolus given at time-point 0' | Drug | – |
Primary outcome
Plasma insulin, glucose and C-peptide
Time frame: Minutes: -10, -5, 0, 3, 4, 5, 6, 8, 10, 15, 20, 30, 40, 60, 80, 100, 120, 150, 180
1 secondary outcome
Plasma levels of appetite-regulatory hormones: ghrelin, PYY and nesfatin-1.
Time frame: Minutes: -10, 0, 30, 60, 120, 180
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 1 Jun 2011.
- Results publication: PubMed 20484150Vila G, Krebs M, Riedl M, Baumgartner-Parzer SM, Clodi M, Maier C, Pacini G, Luger A. Acute effects of hydrocortisone on the metabolic response to a glucose load: increase in the first-phase insulin secretion. Eur J Endocrinol. 2010 Aug;163(2):225-31. doi: 10.1530/EJE-10-0282. Epub 2010 May 18.
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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.
Anton Luger, MD principal investigator
Medical University of Vienna
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Hydrocortisone and Glucose 33% in people with Healthy, run by Medical University of Vienna at 1 site in Austria.
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 4 inclusion and 5 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 1 Jun 2011. 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 Austria. 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.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
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?
Plasma insulin, glucose and C-peptide (time frame: Minutes: -10, -5, 0, 3, 4, 5, 6, 8, 10, 15, 20, 30, 40, 60, 80, 100, 120, 150, 180). 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 NCT00709839, which also lists 1 linked publication.
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 1 Jun 2011.