Viewing Study NCT04482738



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Last Modification Date: 2024-10-26 @ 1:40 PM
Study NCT ID: NCT04482738
Status: COMPLETED
Last Update Posted: 2022-03-23
First Post: 2020-03-30

Brief Title: Study of the Effects of Overfeeding on Glucocorticoids in Lean and Obese Subjects
Sponsor: Eleonora Seelig
Organization: University Hospital Basel Switzerland

Study Overview

Official Title: The Acute Response of Glucocorticoids Upon Food Intake
Status: COMPLETED
Status Verified Date: 2022-03
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-Food
Brief Summary: Investigators suggest that in lean subjects cortisol increases in response to overfeeding and that this increase is blunted in obese subjects A group of 18 male healthy lean subjects and another group of 18 male healthy obese subjects will undergo a high-calorie meal test Prior to the meal intake an indirect calorimetry bioelectrical impedance heart rate variability a fasting blood sample and a perceived stress questionnaire will be assessed After intake of the study meal blood tests will be performed in order to measure the secretion of cortisol glucose and lipid metabolism and inflammatory markers Indirect calorimetry will be assessed again 60 and 180 minutes after the meal intake
Detailed Description: Obesity is one of the most serious health problems in the 21st century High energy food and a sedentary lifestyle are driving the current obesity pandemic These factors activate the hypothalamic-pituitary-adrenal HPA axis the key regulatory pathway of energy homeostasis Activation of the HPA-axis leads to secretion of glucocorticoids from the adrenal glands which control energy homeostasis by mobilizing and redistributing energy substrates

Animal models of obesity have shown that glucocorticoids play a key role in the development of the metabolic syndrome However studies in humans yielded conflicting results These studies have a major limitation in common They do not consider glucocorticoid rhythmicity but rather investigate a snapshot of glucocorticoid secretion Rhythmicity however is crucial because already minor glucocorticoid phase disturbances cause disease and could contribute to obesity

Interestingly excessive food intake may increase cortisol levels in healthy subjects The consequence of this food-induced cortisol peak is not understood but it may be key to restoring energy homeostasis after a meal Whether the food-induced cortisol peak in obese subjects is disturbed is not known

With this study investigators aim to better understand the role played by glucocorticoids in the origin of overweight and obesity Researchers will investigate in lean and obese subjects whether the pulsatile release of cortisol increases after intake of a high-calorie meal 36 subjects will take part in the study a group of 18 male lean subjects and a second group of 18 male obese patients

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