ClinicalTrials.gg
CompletedNCT06556277Gluco-MaxUpdated May 22, 2026

Acute Consequences of Glucocorticoid Secretion in Overweight and Obese Individuals During Maximum Calorie Intake

An interventional study of Metyrapone And Hydrocortisone and Placebo in Glucocorticoids, Overweight and Obesity and Overeating, sponsored by Eleonora Seelig. Completed at 1 site in Switzerland. Open to male participants aged 18 Years to 50 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2026-05-22.

Primary conditionObesityRegistry: OverweightReclassifiedWhy we changed it
Registry
Overweight — the first condition term the registry derived for this study.
ClinicalTrials.gg
Obesity
Why
  1. The study's listed conditions name Obesity, a narrower term within Overweight.
Confidence
High: the new condition is named in the study's own listed conditions. Of 351 hand-checked studies reclassified this way, 68% were exactly right and 84% in the right disease family; the registry's first term was right for 5% (measured 2026-10-21). How we classify →
Wrong?
Tell us the study's main condition →

Sponsored by Eleonora Seelig · Not applicable, Interventional, and Other

Phase
Not applicable
Study type
Interventional
Enrollment
23
Allocation
Randomized
Ages
18 Years to 50 Years
Sex
Male
01

Study 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) 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.

A) 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)

B) 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)

02

Conditions studied

  • Glucocorticoids
  • Overweight and Obesity
  • Overeating

Browse trials for

03

In context

Obesity Reclassified

11,522 studies on the registry are indexed under Obesity; 2,033 are open to participants now.

This study's enrollment of 23 is below the median of 67 across 9,006 interventional studies indexed under Obesity.

Browse Obesity studies →

Lead sponsor

Eleonora Seelig is the lead sponsor of 6 studies on the registry; none are open to participants now.

Compared within Obesity, this study's primary condition as ClinicalTrials.gg classifies it; the registry's first condition term is Overweight. The counts are of registry records indexed under each term, refreshed daily. How we classify →

04

Who can participate

Ages eligible
18 Years to 50 Years
Sexes eligible
Male
Accepts healthy volunteers
Yes

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

  • Males aged 18 to 50 years
  • ≥ 25 kg/m² with a stable weight within past three months before study initiation

Exclusion criteria

Exclusion Criteria:

  • 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)
  • Regular physical exercise (more than 4hrs per week)
  • Shift work
  • Participation in an drug trial within the past two months
  • Intake of any -containing drugs, including topical steroids and inhalers, within 4 weeks of the study initiation
  • Known allergy to metyrapone
  • Inability or unwillingness to provide
Terms in these criteria, in plain language(4)

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.

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.

Investigational drug or device

A drug or device being studied in a clinical trial.

It may be new, or already approved and being studied for another use, dose or form. Criteria often leave out people who took part in another study of one within a recent period, commonly 30 days or five half-lives.

Corticosteroids (steroids)

Anti-inflammatory medicines such as prednisone, prednisolone and dexamethasone — not the anabolic steroids used for muscle.

Studies differ in what they allow: check which steroid medicines, routes (tablets, injections, creams, inhalers, eye drops) and doses this study accepts.

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.

05

Study design

Phase
Not applicable
Primary purpose
Other
Allocation
Randomized
Intervention model
Crossover assignment
Masking
Double (Participant, Investigator)
Enrollment
23 participants (actual)

Study arms

  • Experimental
    Metyrapone And Hydrocortisone

    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).

    Drug: Metyrapone And Hydrocortisone

  • Placebo comparator
    Placebo

    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.

    Drug: Placebo

Interventions

  • DrugMetyrapone And Hydrocortisone

    Drug pages: Metyrapone · Hydrocortisone

    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

  • DrugPlacebo

    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

06

What researchers measure

Primary outcomes

  1. Total body fat

    Change in total body fat assessed with a Dual-Energy-X-Ray-Absorptiometry (DXA)

    Time frame: Two 7-day intervention periods

Secondary outcomes

  1. Total lean mass

    Change in total lean mass assessed with DXA

    Time frame: Two 7-day intervention periods

  2. Insulin sensitivity

    Change in insulin sensitivity assessed with a mixed meal tolerance test

    Time frame: Two 7-day intervention periods

  3. Glucose

    Change in Glucose assessed with a mixed meal tolerance test

    Time frame: Two 7-day intervention periods

  4. Insulin

    Change in Insulin assessed with a mixed meal tolerance test

    Time frame: Two 7-day intervention periods

  5. C-peptide

    Change in C-peptide assessed with a mixed meal tolerance test

    Time frame: Two 7-day intervention periods

  6. Energy expenditure

    Basal metabolic rate measured with indirect calorimetryy

    Time frame: Two 7-day intervention periods

  7. Substrate utilization

    Respiratory quotient assessed with indirect calorimetry

    Time frame: Two 7-day intervention periods

  8. Systolic and diastolic blood pressure

    Assessment of blood pressure with a standard blood pressure monitor.

    Time frame: Two 7-day intervention periods

  9. Weight

    Measurement of weight with a standard scale

    Time frame: Two 7-day intervention periods

  10. Lipids (mmol/l) ((total cholesterol, LDL-cholesterol, HDL-cholesterol and triglycerides)

    Blood sample

    Time frame: Two 7-day intervention periods

  11. Immune cells (peripheral blood mononuclear cells)

    Blood sample

    Time frame: Two 7-day intervention periods

  12. Satiation

    Amount of food intake with ad libitum buffet

    Time frame: Two 7-day intervention periods

  13. Satiety

    Appetite rating with visual analogue scale (VAS) from 0mm-100mm (0mm=not at all and 100mm=extreme)

    Time frame: Two 7-day intervention periods

  14. Motivation

    Motivation to eat measured with a speed clicking test

    Time frame: Two 7-day intervention periods

  15. IL-6 (Inflammatory markers)

    Blood sample

    Time frame: Two 7-day intervention periods

  16. IL-1RA (Inflammatory markers)

    Blood sample

    Time frame: Two 7-day intervention periods

  17. IL-8 (Inflammatory markers)

    Blood sample

    Time frame: Two 7-day intervention periods

  18. CRP (Inflammatory markers)

    Blood sample

    Time frame: Two 7-day intervention periods

  19. Thyroid hormones

    Blood sample

    Time frame: Two 7-day intervention periods

  20. Growth hormone

    Blood sample

    Time frame: Two 7-day intervention periods

  21. IGF1

    Blood sample

    Time frame: Two 7-day intervention periods

  22. Catecholamines

    Blood sample

    Time frame: Two 7-day intervention periods

  23. GLP-1

    Blood sample

    Time frame: Two 7-day intervention periods

  24. GIP

    Blood sample

    Time frame: Two 7-day intervention periods

  25. Glucagon

    Blood sample

    Time frame: Two 7-day intervention periods

  26. PYY

    Blood sample

    Time frame: Two 7-day intervention periods

  27. CCK

    Blood sample

    Time frame: Two 7-day intervention periods

  28. FGF21

    Blood sample

    Time frame: Two 7-day intervention periods

  29. Leptin

    Blood sample

    Time frame: Two 7-day intervention periods

  30. Ghrelin

    Blood sample

    Time frame: Two 7-day intervention periods

  31. GDF15

    Blood sample

    Time frame: Two 7-day intervention periods

  32. Cortisol

    Blood sample

    Time frame: Two 7-day intervention periods

  33. Aldosterone

    Blood sample

    Time frame: Two 7-day intervention periods

  34. Renin

    Blood sample

    Time frame: Two 7-day intervention periods

  35. ACTH

    Blood sample

    Time frame: Two 7-day intervention periods

  36. Pregnenolone

    Blood sample

    Time frame: Two 7-day intervention periods

  37. Progesterone

    Blood sample

    Time frame: Two 7-day intervention periods

  38. 11-deoxycorticosterone

    Blood sample

    Time frame: Two 7-day intervention periods

  39. Corticosterone

    Blood sample

    Time frame: Two 7-day intervention periods

  40. 18-hydroxycorticosterone

    Blood sample

    Time frame: Two 7-day intervention periods

  41. 17-hydroxypregnenolone

    Blood sample

    Time frame: Two 7-day intervention periods

  42. 17-hydroxyprogesterone

    Blood sample

    Time frame: Two 7-day intervention periods

  43. 11-deoxycortisol

    Blood sample

    Time frame: Two 7-day intervention periods

  44. Oxytocin

    Blood sample

    Time frame: Two 7-day intervention periods

Other outcomes

  1. Untargeted metabolomics of blood

    Blood sample

    Time frame: Two 7-day intervention periods

  2. Untargeted metabolomics of adipose tissue

    Adipose tissue sample

    Time frame: Two 7-day intervention periods

  3. Untargeted metabolomics of muscle

    Muscle tissue sample

    Time frame: Two 7-day intervention periods

  4. Gene expression analysis of adipose tissue

    Adipose tissue sample

    Time frame: Two 7-day intervention periods

  5. Gene expressions analysis of muscle tissue

    Muscle tissue sample

    Time frame: Two 7-day intervention periods

07

Study locations

1 site
  • University Hospital Basel
    Basel, Canton of Basel-City 4031, Switzerland
08

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

09

Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reachedSimilar studies: half by the dot; the band is the middle halfHalf of similar studies reached it by the dot; the band is the middle half, from a quarter to three quarters

Ran from Sep 2024 to primary completion in Feb 2026, 17 months.

Of 3,680 non-industry interventional studies with no phase under Obesity, half reached primary completion within 23 months of starting (the median), counting those still running; a quarter within 10 and three quarters within 43. This study's 17 months is below that.

Counting every sponsor, half of 3,843 studies reached it within 22 months; a quarter within 10 and three quarters within 42.

How these figures are worked out, and which studies are left out of them.

Registered
Jul 17, 2024
First posted
Aug 16, 2024
StartActual
Sep 1, 2024
Primary completionActual
Feb 25, 2026
CompletionActual
Feb 25, 2026
Last update
May 22, 2026
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on May 22, 2026, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT06556277
Lead sponsor
Eleonora Seelig
Responsible party
Eleonora Seelig (Principal Investigator, University Hospital, Basel, Switzerland) — Sponsor-investigator
First posted
Aug 16, 2024
Start date
Sep 1, 2024
Primary completion
Feb 25, 2026
Completion
Feb 25, 2026
Last update
May 22, 2026

Study contacts

Eleonora Seelig, PD Dr.med.
principal investigator · Sponsor and principal investigator

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in May 2026. You cannot join it, but the record below documents what was studied.

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Studies of the drugs tested here: Metyrapone · Hydrocortisone

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