Acute Consequences of Glucocorticoid Secretion in Overweight and Obese Individuals During Maximum Calorie Intake
NCT Number: NCT06556277
Acronym: Gluco-Max
Status: NOT_YET_RECRUITING
Study Type: INTERVENTIONAL
Phases: NA
Conditions: Glucocorticoids|Overweight and Obesity|Overeating
Interventions: DRUG: Metyrapone And Hydrocortisone|DRUG: Placebo
Sponsor: Eleonora Seelig
Sex: MALE
Age: ADULT
Enrollment: 23
Study Design: Allocation: RANDOMIZED|Intervention Model: CROSSOVER|Masking: DOUBLE (PARTICIPANT, INVESTIGATOR)|Primary Purpose: OTHER
Start Date: 2024-08
Completion Date: 2026-07

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.

Primary Outcome Measures: Total body fat, Change in total body fat assessed with a Dual-Energy-X-Ray-Absorptiometry (DXA), Two 7-day intervention periods
Secondary Outcome Measures: Total lean mass, Change in total lean mass assessed with DXA, Two 7-day intervention periods|Insulin sensitivity, Change in insulin sensitivity assessed with a mixed meal tolerance test, Two 7-day intervention periods|Glucose, Change in Glucose assessed with a mixed meal tolerance test, Two 7-day intervention periods|Insulin, Change in Insulin assessed with a mixed meal tolerance test, Two 7-day intervention periods|C-peptide, Change in C-peptide assessed with a mixed meal tolerance test, Two 7-day intervention periods|Energy expenditure, Basal metabolic rate measured with indirect calorimetryy, Two 7-day intervention periods|Substrate utilization, Respiratory quotient assessed with indirect calorimetry, Two 7-day intervention periods|Systolic and diastolic blood pressure, Assessment of blood pressure with a standard blood pressure monitor., Two 7-day intervention periods|Weight, Measurement of weight with a standard scale, Two 7-day intervention periods|Lipids (mmol/l) ((total cholesterol, LDL-cholesterol, HDL-cholesterol and triglycerides), Blood sample, Two 7-day intervention periods|Immune cells (peripheral blood mononuclear cells), Blood sample, Two 7-day intervention periods|Satiation, Amount of food intake with ad libitum buffet, Two 7-day intervention periods|Satiety, Appetite rating with visual analogue scale (VAS) from 0mm-100mm (0mm=not at all and 100mm=extreme), Two 7-day intervention periods|Motivation, Motivation to eat measured with a speed clicking test, Two 7-day intervention periods|IL-6 (Inflammatory markers), Blood sample, Two 7-day intervention periods|IL-1RA (Inflammatory markers), Blood sample, Two 7-day intervention periods|IL-8 (Inflammatory markers), Blood sample, Two 7-day intervention periods|CRP (Inflammatory markers), Blood sample, Two 7-day intervention periods|Thyroid hormones, Blood sample, Two 7-day intervention periods|Growth hormone, Blood sample, Two 7-day intervention periods|IGF1, Blood sample, Two 7-day intervention periods|Catecholamines, Blood sample, Two 7-day intervention periods|GLP-1, Blood sample, Two 7-day intervention periods|GIP, Blood sample, Two 7-day intervention periods|Glucagon, Blood sample, Two 7-day intervention periods|PYY, Blood sample, Two 7-day intervention periods|CCK, Blood sample, Two 7-day intervention periods|FGF21, Blood sample, Two 7-day intervention periods|Leptin, Blood sample, Two 7-day intervention periods|Ghrelin, Blood sample, Two 7-day intervention periods|GDF15, Blood sample, Two 7-day intervention periods|Cortisol, Blood sample, Two 7-day intervention periods|Aldosterone, Blood sample, Two 7-day intervention periods|Renin, Blood sample, Two 7-day intervention periods|ACTH, Blood sample, Two 7-day intervention periods|Pregnenolone, Blood sample, Two 7-day intervention periods|Progesterone, Blood sample, Two 7-day intervention periods|11-deoxycorticosterone, Blood sample, Two 7-day intervention periods|Corticosterone, Blood sample, Two 7-day intervention periods|18-hydroxycorticosterone, Blood sample, Two 7-day intervention periods|17-hydroxypregnenolone, Blood sample, Two 7-day intervention periods|17-hydroxyprogesterone, Blood sample, Two 7-day intervention periods|11-deoxycortisol, Blood sample, Two 7-day intervention periods|Oxytocin, Blood sample, Two 7-day intervention periods
Other Outcome Measures: Untargeted metabolomics of blood, Blood sample, Two 7-day intervention periods|Untargeted metabolomics of adipose tissue, Adipose tissue sample, Two 7-day intervention periods|Untargeted metabolomics of muscle, Muscle tissue sample, Two 7-day intervention periods|Gene expression analysis of adipose tissue, Adipose tissue sample, Two 7-day intervention periods|Gene expressions analysis of muscle tissue, Muscle tissue sample, Two 7-day intervention periods