Ignite Creation Date:
2024-05-06 @ 7:08 PM
Last Modification Date:
2024-10-26 @ 3:01 PM
Study NCT ID:
NCT05919992
Status:
COMPLETED
Last Update Posted:
2023-06-27
First Post:
2023-03-03
Brief Title:
The Role of Glucocorticoids to Maintain Energy Homeostasis During Starvation Gluco-Starve
Sponsor:
Eleonora Seelig
Organization:
University Hospital Basel Switzerland
Study Overview
Official Title:
The Role of Glucocorticoids to Maintain Energy Homeostasis During Starvation
Status:
COMPLETED
Status Verified Date:
2024-08
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
In a randomized cross-over study 20 healthy volunteers will receive a block and replace therapy that mimics physiological GC rhythm metyrapone plus hydrocortisone or placebo Participants will undergo two identical fasting periods with each treatment With the block and replace therapy fasting-induced GC peak will be suppressed Metabolic and autonomic parameters will be compared to reveal whether GCs mediate the physiological adaptions to caloric restriction
Understanding acute effects of GCs upon caloric restriction is critical since repetitive disruptions of GC secretion may become harmful in chronic conditions
Understanding acute effects of GCs upon caloric restriction is critical since repetitive disruptions of GC secretion may become harmful in chronic conditions
Detailed Description:
Obesity is one of the major causes of morbidity and mortality worldwide Achieving long-term weight loss is challenging as the body counteracts weight loss to preserve energy by increasing appetite and lowering energy expenditure These physiological defense mechanisms are the main obstacle to successful weight reduction in obese people
Therefore identifying the signals that defend body weight during caloric restriction is essential for developing new antiobesity drugs Corticosteroids mediate the physiological defense to starvation in rodents Whether cortisol has the same impact on humans is unknown
Therefore we investigate whether cortisol regulates the physiological adaptions to caloric restriction in humans
The general objective of this project is to investigate whether cortisol mediates physiological adaptions to caloric restriction
The primary objective is to test whether cortisol mediates the increased appetite during caloric restriction
Secondary objectives are to test whether the cortisol response to caloric restriction affects satiation satiety energy expenditure substrate utilization blood pressure weight body composition secretion of neuroendocrine hormones lipids glucose ketone bodies sympathetic nervous system activity immune cells and inflammatory markers
This is a double-blind randomized placebo-controlled crossover study
After screening subjects will be randomized to two crossover 7-day study periods with a wash-out period of 28 days
A Participants will receive hydrocortisone 199 mgd subcutaneously via a pump in a pulsed fashion eight timesday and metyrapone capsules per os starting with a dose of 500 mgd on day 1 to 3000mgd on day 5 and then will be kept constant until day 7
B Participants will receive a placebo 09 NaCl solution subcutaneously via a pump in a pulsed fashion and identical-looking placebo capsules per os with the same regimen as for metyrapone
During both study periods participants will undergo two days of caloric restriction
Therefore identifying the signals that defend body weight during caloric restriction is essential for developing new antiobesity drugs Corticosteroids mediate the physiological defense to starvation in rodents Whether cortisol has the same impact on humans is unknown
Therefore we investigate whether cortisol regulates the physiological adaptions to caloric restriction in humans
The general objective of this project is to investigate whether cortisol mediates physiological adaptions to caloric restriction
The primary objective is to test whether cortisol mediates the increased appetite during caloric restriction
Secondary objectives are to test whether the cortisol response to caloric restriction affects satiation satiety energy expenditure substrate utilization blood pressure weight body composition secretion of neuroendocrine hormones lipids glucose ketone bodies sympathetic nervous system activity immune cells and inflammatory markers
This is a double-blind randomized placebo-controlled crossover study
After screening subjects will be randomized to two crossover 7-day study periods with a wash-out period of 28 days
A Participants will receive hydrocortisone 199 mgd subcutaneously via a pump in a pulsed fashion eight timesday and metyrapone capsules per os starting with a dose of 500 mgd on day 1 to 3000mgd on day 5 and then will be kept constant until day 7
B Participants will receive a placebo 09 NaCl solution subcutaneously via a pump in a pulsed fashion and identical-looking placebo capsules per os with the same regimen as for metyrapone
During both study periods participants will undergo two days of caloric restriction
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None