GlucocorticoidsGluco-MaxNCT06556277
Acute Consequences of Glucocorticoid Secretion in Overweight and Obese Individuals During Maximum Calorie Intake
A study testing Metyrapone And Hydrocortisone in people with Glucocorticoids and Overweight and Obesity, run by Eleonora Seelig at 1 site in Switzerland.
Trial summary
The investigator aim to understand whether food-induced glucocorticoids influence fat mass in overweight and obese people. In a randomized, cross-over study, 23 overweight and obese volunteers will receive a block and replace therapy that mimics physiological glucocorticoid (GC) rhythm (metyrapone plus hydrocortisone)… Read more about this study
- Who is it for?
- Ages 18 to 50 years, men onlyHealthy volunteers can take part
- Conditions the study is for
- Glucocorticoids, Overweight and Obesity, Overeating
- What is being tested?
- Metyrapone And Hydrocortisone
- Type of treatment
- Pill or oral medicine, Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 23 participants
- Where
- 1 siteSwitzerland
- Study dates
- 1 Sep 2024to 25 Feb 2026
- 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 50 years
- Men only
- Healthy volunteers accepted
- Adult
Who may be able to join
- Males aged 18 to 50 years
- BMI≥ 25 kg/m² with a stable weight within past three months before study initiation
Who cannot join
- Any severe acute or chronic disease, including diabetes mellitus type 2
- Intake of GLP-1 agonists or hormone therapy
- Hypercortisolism
- Casual smoking (more than 6 cigarettes per day)
- Frequent, heavy alcohol consumption (more than 30g/day)
- Frequent, heavy caffeine consumption (more than 4 caffeinated drinks/day)
Show all 12Show fewer
- Regular physical exercise (more than 4hrs per week)
- Shift work
- Participation in an investigational drug trial within the past two months
- Intake of any steroid-containing drugs, including topical steroids and inhalers, within 4 weeks of the study initiation
- Known allergy to metyrapone
- Inability or unwillingness to provide informed consent
Trial locations and contacts
1 site in 1 country.
Switzerland1 site
University Hospital Basel
Basel, Canton of Basel-City, 4031
About this study
Official title: Acute Consequences of Glucocorticoid Secretion in Overweight and Obese Individuals During Maximum Calorie Intake: a Double-blind, Randomized, Placebo-controlled, Cross-over Study
The investigator aim to understand whether food-induced glucocorticoids influence fat mass in overweight and obese people.
In a randomized, cross-over study, 23 overweight and obese volunteers will receive a block and replace therapy that mimics physiological glucocorticoid (GC) rhythm (metyrapone plus hydrocortisone) or placebo. Participants will undergo two identical overfeeding periods with each treatment. With the block and replace therapy food-induced GC peak will be suppressed. Metabolic and immunological parameters will be compared to reveal the effects of GCs during excessive overfeeding, particularly to understand changes in body fat.
Read the detailed description
Obesity is one of the most serious health problems of the 21st century, and new therapies are urgently needed.
Glucocorticoids (GCs) increase with acute food intake. Several clinical studies have found that glucocorticoids contribute to common obesity, but the underlying mechanisms remain unknown. Here, the investigator aim to understand whether GCs influence the total body fat in obese and overweight study participants during excessive overfeeding.
In a randomized, cross-over study, 23 overweight and obese individuals will receive a block and replace therapy that mimics physiological GC rhythm (Metyrapone plus hydrocortisone) or placebo. Participants will undergo two identical overfeeding periods with each treatment. With the block and replace therapy, food-induced GC peak will be suppressed. Metabolic, autonomic, and immunological parameters will be compared.
- Participants will receive hydrocortisone 19.9mg/d day 1 to day 6 and 12mg on day 7 subcutaneously via a pump in a pulsed fashion (eight times/day) and metyrapone per os (starting with a dose of 750mg/d on day 1 to 2500mg on day 3, which will be kept constant until day 6 and then reduced to 750mg on day 7)
- Participants will receive placebo (0,9% NaCl solution) 19.9mg/d day 1 to day 6 and 12mg on day 7 subcutaneously via a pump in a pulsed fashion (eight times/day) and placebo pills per os (starting with a dose of 750mg/d on day 1 to 2500mg on day 3, which will be kept constant until day 6 and then reduced to 750mg on day 7)
- Conditions
- Glucocorticoids, Overweight and Obesity, Overeating
- Being tested
- Metyrapone And Hydrocortisone, Placebo
- Medical subject headings
- Overweight, Obesity, Hyperphagia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Metyrapone And HydrocortisoneDrug
Drug: Metyrapone 250 mg Oral Tablets
During one phase of the study: Metyrapone (pills of 250mg) on full stomach: Day 1 0-1-2, day 2 1-2-2, day 3 3-3-4 day 4 3-3-4 day 5 3-3-4 day 6 3-3-4 day 7 3-0-0
Drug: Hydrocortisone 19,9mg/12mg s.c., pulsatile with a flow rate of 10μl/s
Hydrocortisone will be delivered subcutaneously via a pump in a pulsed fashion with a flow rate of 10μl/s from day 1 to day 6 in a total daily dose of 19.9mg and 12mg on day 7
PlaceboDrug
Drug: Placebo 250 mg Tablets
During another phase of the study: identical looking placebo pills starting Day 1 During one phase of the study: Metyrapone (pills of 250mg) on full stomach: Day 1 0-1-2, day 2 1-2-2, day 3 3-3-4 day 4 3-3-4 day 5 3-3-4 day 6 3-3-4 day 7 3-0-0
Drug: Placebo (0,9% NaCl solution)
Placebo (0,9% NaCl solution) 19.9 mg/d subcutaneously via a pump in a pulsed fashion with a flow rate of 10μl/s from day 1 to day 6 and 12mg on day 7
| Study group | Role | What they receive |
|---|---|---|
| Metyrapone And Hydrocortisone | Experimental | During one of the study periods, subjects receive hydrocortisone 19.9 mg/d day 1 to day 6 and 12 mg/d on day 7 subcutaneously via a pump in a pulsed fashion (eight times/day) and metyrapone per os (starting with a dose of 750 mg/d, then the dose will be increased on day 3, where 2500mg/d is achieved and reduced on day 7 to 750mg). Receives: Drug: Metyrapone And Hydrocortisone |
| Placebo | Placebo comparator | During the other study period, subjects receive placebo (0,9% NaCl solution) the same dose of placebo instead of hydrocortisone subcutaneously via a pump in a pulsed fashion and the same dose of placebo tablets p.o instead of metyrapone. Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Total body fat
Change in total body fat assessed with a Dual-Energy-X-Ray-Absorptiometry (DXA)
Measured: Two 7-day intervention periods
Secondary outcomes (44)
Total lean mass
Change in total lean mass assessed with DXA
Measured: Two 7-day intervention periods
Insulin sensitivity
Change in insulin sensitivity assessed with a mixed meal tolerance test
Measured: Two 7-day intervention periods
Glucose
Change in Glucose assessed with a mixed meal tolerance test
Measured: Two 7-day intervention periods
Insulin
Change in Insulin assessed with a mixed meal tolerance test
Measured: Two 7-day intervention periods
C-peptide
Change in C-peptide assessed with a mixed meal tolerance test
Measured: Two 7-day intervention periods
Energy expenditure
Basal metabolic rate measured with indirect calorimetryy
Measured: Two 7-day intervention periods
Substrate utilization
Respiratory quotient assessed with indirect calorimetry
Measured: Two 7-day intervention periods
Systolic and diastolic blood pressure
Assessment of blood pressure with a standard blood pressure monitor.
Measured: Two 7-day intervention periods
Weight
Measurement of weight with a standard scale
Measured: Two 7-day intervention periods
Lipids (mmol/l) ((total cholesterol, LDL-cholesterol, HDL-cholesterol and triglycerides)
Blood sample
Measured: Two 7-day intervention periods
Immune cells (peripheral blood mononuclear cells)
Blood sample
Measured: Two 7-day intervention periods
Satiation
Amount of food intake with ad libitum buffet
Measured: Two 7-day intervention periods
Satiety
Appetite rating with visual analogue scale (VAS) from 0mm-100mm (0mm=not at all and 100mm=extreme)
Measured: Two 7-day intervention periods
Motivation
Motivation to eat measured with a speed clicking test
Measured: Two 7-day intervention periods
IL-6 (Inflammatory markers)
Blood sample
Measured: Two 7-day intervention periods
IL-1RA (Inflammatory markers)
Blood sample
Measured: Two 7-day intervention periods
IL-8 (Inflammatory markers)
Blood sample
Measured: Two 7-day intervention periods
CRP (Inflammatory markers)
Blood sample
Measured: Two 7-day intervention periods
Thyroid hormones
Blood sample
Measured: Two 7-day intervention periods
Growth hormone
Blood sample
Measured: Two 7-day intervention periods
IGF1
Blood sample
Measured: Two 7-day intervention periods
Catecholamines
Blood sample
Measured: Two 7-day intervention periods
GLP-1
Blood sample
Measured: Two 7-day intervention periods
GIP
Blood sample
Measured: Two 7-day intervention periods
Glucagon
Blood sample
Measured: Two 7-day intervention periods
PYY
Blood sample
Measured: Two 7-day intervention periods
CCK
Blood sample
Measured: Two 7-day intervention periods
FGF21
Blood sample
Measured: Two 7-day intervention periods
Leptin
Blood sample
Measured: Two 7-day intervention periods
Ghrelin
Blood sample
Measured: Two 7-day intervention periods
GDF15
Blood sample
Measured: Two 7-day intervention periods
Cortisol
Blood sample
Measured: Two 7-day intervention periods
Aldosterone
Blood sample
Measured: Two 7-day intervention periods
Renin
Blood sample
Measured: Two 7-day intervention periods
ACTH
Blood sample
Measured: Two 7-day intervention periods
Pregnenolone
Blood sample
Measured: Two 7-day intervention periods
Progesterone
Blood sample
Measured: Two 7-day intervention periods
11-deoxycorticosterone
Blood sample
Measured: Two 7-day intervention periods
Corticosterone
Blood sample
Measured: Two 7-day intervention periods
18-hydroxycorticosterone
Blood sample
Measured: Two 7-day intervention periods
17-hydroxypregnenolone
Blood sample
Measured: Two 7-day intervention periods
17-hydroxyprogesterone
Blood sample
Measured: Two 7-day intervention periods
11-deoxycortisol
Blood sample
Measured: Two 7-day intervention periods
Oxytocin
Blood sample
Measured: Two 7-day intervention periods
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Aug 2024
- Study start1 Sep 2024
- Primary completion25 Feb 2026
- Study completion25 Feb 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for GlucocorticoidsStudies of the same condition, open and under way.
- 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
- Other
- Allocation
- Randomised
- Intervention model
- Crossover
- Model description
- Double-blind, randomized, placebo-controlled cross-over study
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 23 participants (actual)
Sponsor and investigators
- Lead sponsor
- Eleonora Seelig
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Eleonora Seelig, University Hospital, Basel, Switzerland
- Investigators
- Eleonora Seelig, PD Dr.med., Principal investigator, Sponsor and principal investigator
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06556277
- Sponsor's protocol ID
- EKNZ 2024-01381
- Acronym
- Gluco-Max
- Status last verified
- May 2026
- First submitted
- 17 Jul 2024
- Last updated
- 22 May 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 22 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Acute Consequences of Glucocorticoid Secretion in Overweight and Obese Individuals During Maximum Calorie Intake: a Double-blind, Randomized, Placebo-controlled, Cross-over Study
- ClinicalTrials.gov ID
- NCT06556277
- Acronym / sponsor ID
- Gluco-Max / EKNZ 2024-01381
- Conditions
- Glucocorticoids, Overweight and Obesity, Overeating
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 23 participants (actual)
- Lead sponsor
- Eleonora SeeligUniversity, hospital or other
- Study start
- 1 Sep 2024 (actual)
- Primary completion
- 25 Feb 2026 (actual)
- Study completion
- 25 Feb 2026 (actual)
- First posted
- 16 Aug 2024 (actual)
- 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 investigator aim to understand whether food-induced glucocorticoids influence fat mass in overweight and obese people.
In a randomized, cross-over study, 23 overweight and obese volunteers will receive a block and replace therapy that mimics physiological glucocorticoid (GC) rhythm (metyrapone plus hydrocortisone) or placebo. Participants will undergo two identical overfeeding periods with each treatment. With the block and replace therapy food-induced GC peak will be suppressed. Metabolic and immunological parameters will be compared to reveal the effects of GCs during excessive overfeeding, particularly to understand changes in body fat.
Detailed description
Obesity is one of the most serious health problems of the 21st century, and new therapies are urgently needed.
Glucocorticoids (GCs) increase with acute food intake. Several clinical studies have found that glucocorticoids contribute to common obesity, but the underlying mechanisms remain unknown. Here, the investigator aim to understand whether GCs influence the total body fat in obese and overweight study participants during excessive overfeeding.
In a randomized, cross-over study, 23 overweight and obese individuals will receive a block and replace therapy that mimics physiological GC rhythm (Metyrapone plus hydrocortisone) or placebo. Participants will undergo two identical overfeeding periods with each treatment. With the block and replace therapy, food-induced GC peak will be suppressed. Metabolic, autonomic, and immunological parameters will be compared.
- Participants will receive hydrocortisone 19.9mg/d day 1 to day 6 and 12mg on day 7 subcutaneously via a pump in a pulsed fashion (eight times/day) and metyrapone per os (starting with a dose of 750mg/d on day 1 to 2500mg on day 3, which will be kept constant until day 6 and then reduced to 750mg on day 7)
- Participants will receive placebo (0,9% NaCl solution) 19.9mg/d day 1 to day 6 and 12mg on day 7 subcutaneously via a pump in a pulsed fashion (eight times/day) and placebo pills per os (starting with a dose of 750mg/d on day 1 to 2500mg on day 3, which will be kept constant until day 6 and then reduced to 750mg on day 7)
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
- Model description
- Double-blind, randomized, placebo-controlled cross-over study
| Arm | Type | Receives |
|---|---|---|
| Metyrapone And Hydrocortisone | Experimental | Drug: Metyrapone And HydrocortisoneDuring one of the study periods, subjects receive hydrocortisone 19.9 mg/d day 1 to day 6 and 12 mg/d on day 7 subcutaneously via a pump in a pulsed fashion (eight times/day) and metyrapone per os (starting with a dose of 750 mg/d, then the dose will be increased on day 3, where 2500mg/d is achieved and reduced on day 7 to 750mg). |
| Placebo | Placebo comparator | Drug: PlaceboDuring the other study period, subjects receive placebo (0,9% NaCl solution) the same dose of placebo instead of hydrocortisone subcutaneously via a pump in a pulsed fashion and the same dose of placebo tablets p.o instead of metyrapone. |
Who may qualify
- Ages
- 18 to 50 years
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (2 listed)
- Males aged 18 to 50 years
- BMI≥ 25 kg/m² with a stable weight within past three months before study initiation
Key exclusion criteria (12 listed)
- Any severe acute or chronic disease, including diabetes mellitus type 2
- Intake of GLP-1 agonists or hormone therapy
- Hypercortisolism
- Casual smoking (more than 6 cigarettes per day)
- Frequent, heavy alcohol consumption (more than 30g/day)
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 |
|---|---|---|
| Metyrapone And HydrocortisoneDrug: Metyrapone 250 mg Oral Tablets During one phase of the study: Metyrapone (pills of 250mg) on full stomach: Day 1 0-1-2, day 2 1-2-2, day 3 3-3-4 day 4 3-3-4 day 5 3-3-4 day 6 3-3-4 day 7 3-0-0 Drug: Hydrocortisone 19,9mg/12mg s.c., pulsatile with a flow rate of 10μl/s Hydrocortisone will be delivered subcutaneously via a pump in a pulsed fashion with a flow rate of 10μl/s from day 1 to day 6 in a total daily dose of 19.9mg and 12mg on day 7 | Drug | Metyrapone And Hydrocortisone |
| PlaceboDrug: Placebo 250 mg Tablets During another phase of the study: identical looking placebo pills starting Day 1 During one phase of the study: Metyrapone (pills of 250mg) on full stomach: Day 1 0-1-2, day 2 1-2-2, day 3 3-3-4 day 4 3-3-4 day 5 3-3-4 day 6 3-3-4 day 7 3-0-0 Drug: Placebo (0,9% NaCl solution) Placebo (0,9% NaCl solution) 19.9 mg/d subcutaneously via a pump in a pulsed fashion with a flow rate of 10μl/s from day 1 to day 6 and 12mg on day 7 | Drug | Placebo |
Primary outcome
Total body fat
Time frame: Two 7-day intervention periods
Change in total body fat assessed with a Dual-Energy-X-Ray-Absorptiometry (DXA)
44 secondary outcomes
Total lean mass
Time frame: Two 7-day intervention periods
Insulin sensitivity
Time frame: Two 7-day intervention periods
Glucose
Time frame: Two 7-day intervention periods
Insulin
Time frame: Two 7-day intervention periods
C-peptide
Time frame: Two 7-day intervention periods
Energy expenditure
Time frame: Two 7-day intervention periods
Substrate utilization
Time frame: Two 7-day intervention periods
Systolic and diastolic blood pressure
Time frame: Two 7-day intervention periods
Weight
Time frame: Two 7-day intervention periods
Lipids (mmol/l) ((total cholesterol, LDL-cholesterol, HDL-cholesterol and triglycerides)
Time frame: Two 7-day intervention periods
Immune cells (peripheral blood mononuclear cells)
Time frame: Two 7-day intervention periods
Satiation
Time frame: Two 7-day intervention periods
Satiety
Time frame: Two 7-day intervention periods
Motivation
Time frame: Two 7-day intervention periods
IL-6 (Inflammatory markers)
Time frame: Two 7-day intervention periods
IL-1RA (Inflammatory markers)
Time frame: Two 7-day intervention periods
IL-8 (Inflammatory markers)
Time frame: Two 7-day intervention periods
CRP (Inflammatory markers)
Time frame: Two 7-day intervention periods
Thyroid hormones
Time frame: Two 7-day intervention periods
Growth hormone
Time frame: Two 7-day intervention periods
IGF1
Time frame: Two 7-day intervention periods
Catecholamines
Time frame: Two 7-day intervention periods
GLP-1
Time frame: Two 7-day intervention periods
GIP
Time frame: Two 7-day intervention periods
Glucagon
Time frame: Two 7-day intervention periods
PYY
Time frame: Two 7-day intervention periods
CCK
Time frame: Two 7-day intervention periods
FGF21
Time frame: Two 7-day intervention periods
Leptin
Time frame: Two 7-day intervention periods
Ghrelin
Time frame: Two 7-day intervention periods
GDF15
Time frame: Two 7-day intervention periods
Cortisol
Time frame: Two 7-day intervention periods
Aldosterone
Time frame: Two 7-day intervention periods
Renin
Time frame: Two 7-day intervention periods
ACTH
Time frame: Two 7-day intervention periods
Pregnenolone
Time frame: Two 7-day intervention periods
Progesterone
Time frame: Two 7-day intervention periods
11-deoxycorticosterone
Time frame: Two 7-day intervention periods
Corticosterone
Time frame: Two 7-day intervention periods
18-hydroxycorticosterone
Time frame: Two 7-day intervention periods
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 22 May 2026.
- Individual participant dataSharing planned: No
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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.
Eleonora Seelig, PD Dr.med. principal investigator
Sponsor and principal investigator
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Metyrapone And Hydrocortisone in people with Glucocorticoids and Overweight and Obesity, run by Eleonora Seelig at 1 site in Switzerland.
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 2 inclusion and 12 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 22 May 2026. 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 Switzerland. 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.
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?
Total body fat (time frame: Two 7-day intervention periods). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 22 May 2026.