Ignite Creation Date:
2024-10-26 @ 3:37 PM
Last Modification Date:
2024-10-26 @ 3:37 PM
Study NCT ID:
NCT06556277
Status:
RECRUITING
Last Update Posted:
None
First Post:
2024-07-17
Brief Title:
Acute Consequences of Glucocorticoid Secretion in Overweight and Obese Individuals During Maximum Calorie Intake
Sponsor:
None
Organization:
None
Study Overview
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
Status:
RECRUITING
Status Verified Date:
2024-08
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
No
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
Gluco-Max
Brief 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
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
A Participants will receive hydrocortisone 199mgd day 1 to day 6 and 12mg on day 7 subcutaneously via a pump in a pulsed fashion eight timesday and metyrapone per os starting with a dose of 750mgd 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 09 NaCl solution 199mgd day 1 to day 6 and 12mg on day 7 subcutaneously via a pump in a pulsed fashion eight timesday and placebo pills per os starting with a dose of 750mgd on day 1 to 2500mg on day 3 which will be kept constant until day 6 and then reduced to 750mg on day 7
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 199mgd day 1 to day 6 and 12mg on day 7 subcutaneously via a pump in a pulsed fashion eight timesday and metyrapone per os starting with a dose of 750mgd 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 09 NaCl solution 199mgd day 1 to day 6 and 12mg on day 7 subcutaneously via a pump in a pulsed fashion eight timesday and placebo pills per os starting with a dose of 750mgd 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 Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None