Ignite Creation Date:
2024-05-06 @ 5:01 PM
Last Modification Date:
2024-10-26 @ 2:20 PM
Study NCT ID:
NCT05167084
Status:
COMPLETED
Last Update Posted:
2023-08-23
First Post:
2021-12-08
Brief Title:
Acute Consequences Of Food-induced Glucocorticoid Secretion In Healthy Individuals
Sponsor:
Eleonora Seelig
Organization:
University Hospital Basel Switzerland
Study Overview
Official Title:
Acute Consequences Of Food-induced Glucocorticoid Secretion In Healthy Individuals - A Double-blind Randomized Placebo-controlled Cross-over Study
Status:
COMPLETED
Status Verified Date:
2023-08
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:
Gluco-Feed
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 overfeeding periods with each treatment With the block and replace therapy food-induced GC peak will be suppressed Metabolic and autonomic parameters will be compared to reveal whether GCs mediate the physiological adaptions to excessive food intake
Understanding acute effects of GCs upon food intake is critical since repetitive disruptions of GC secretion may become harmful in chronic conditions
Understanding acute effects of GCs upon food intake is critical since repetitive disruptions of GC secretion may become harmful in chronic conditions
Detailed Description:
Obesity is one of the most serious health problems of the 21st century To understand how we regulate our body weight is crucial for developing new treatment targets Even though body mass index of populations is increasing the body weight of adults is usually kept stable over time Indeed acute excessive food intake triggers a set of adaptions in order to prevent weight gain The signal that triggers these beneficial adaptions is still unknown Glucocorticoid GC secretion increases with acute food intake and many physiological adaptions to overfeeding coincide with classical glucocorticoid actions The investigators therefore hypothesize that GCs are the signal that prevents weight gain during acute overfeeding
The objective of this project is to test whether food-induced GCs represent the physiological signal that defends against weight gain
The primary objective is to investigate whether reduction in insulin sensitivity is abolished with the block and replace therapy
Secondary objectives are to investigate whether suppression of GC secretion during excessive food intake impairs the activation of sympathetic nervous system satiety satiation energy expenditure substrate utilization blood pressure secretion of neuroendocrine hormones lipids and immune cells
This is a double-blind randomized placebo-controlled cross-over study After screening subjects will be randomized to two crossover 8-day study periods with a washout period of 28 days
A Participants will receive hydrocortisone 199 mgd subcutaneously via a pump in a pulsed fashion eight timesday and metyrapone per os starting with a dose of 500 mgd on day 1 to 2500mgd on day 4 and then will be kept constant until day 8
B Participants will receive placebo 09 NaCl solution 199 mgd subcutaneously via a pump in a pulsed fashion and placebo pills per os starting with a dose of 500 mgd on day 1 to 2500mgd on day 4 and then will be kept constant until day 8
The objective of this project is to test whether food-induced GCs represent the physiological signal that defends against weight gain
The primary objective is to investigate whether reduction in insulin sensitivity is abolished with the block and replace therapy
Secondary objectives are to investigate whether suppression of GC secretion during excessive food intake impairs the activation of sympathetic nervous system satiety satiation energy expenditure substrate utilization blood pressure secretion of neuroendocrine hormones lipids and immune cells
This is a double-blind randomized placebo-controlled cross-over study After screening subjects will be randomized to two crossover 8-day study periods with a washout period of 28 days
A Participants will receive hydrocortisone 199 mgd subcutaneously via a pump in a pulsed fashion eight timesday and metyrapone per os starting with a dose of 500 mgd on day 1 to 2500mgd on day 4 and then will be kept constant until day 8
B Participants will receive placebo 09 NaCl solution 199 mgd subcutaneously via a pump in a pulsed fashion and placebo pills per os starting with a dose of 500 mgd on day 1 to 2500mgd on day 4 and then will be kept constant until day 8
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