Ignite Creation Date:
2024-05-06 @ 8:28 PM
Last Modification Date:
2024-10-26 @ 3:28 PM
Study NCT ID:
NCT06390501
Status:
RECRUITING
Last Update Posted:
2024-04-30
First Post:
2024-04-11
Brief Title:
The Effect of Weekly Semaglutide Treatment on Energy Expenditure
Sponsor:
Shenzhen Institute of Advanced Technology Chinese Academy of Sciences
Organization:
Shenzhen Institute of Advanced Technology Chinese Academy of Sciences
Study Overview
Official Title:
The Effect of Weekly Semaglutide Treatment on Energy Expenditure
Status:
RECRUITING
Status Verified Date:
2024-04
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:
This study will test the effects of weekly injections of the glucagon like peptide-1 GLP-1 agonist semaglutide on energy expenditure and metabolic parameters in a 24 week double-blind placebo-controlled dose escalation randomized trial After baseline testing 52 patients will be randomly assigned to the semaglutide or matching placebo injection group In addition to taking medication or placebo all participants will a calorie restricted diet provided by the researchers providing 600 kcals per day below their estimated baseline requirements Before and at the end of treatment weight status body composition basal metabolic rate BEE 24h energy expenditure daily total energy expenditure TEE for free living physical activity energy intake questionnaire and food table and hormone parameters for energy homeostasis will be evaluated
Detailed Description:
Obesity is a complex chronic recurrent multifactorial disease characterized by abnormal or excessive body fat which impairs physical health In recent years the glucagon like peptide-1 GLP-1 receptor agonist semaglutide has attracted much attention due to its significant impact on weight loss It can not only effectively control blood sugar by regulating the secretion of insulin and glucagon It can also participate in certain brain regions of the body at pharmacological doses regulating food intake and consumption Semaglutide reduces energy intake and achieves weight loss by delaying gastric emptying suppressing appetite reducing hunger and increasing satiety This effect has been proven to be produced by activating the glucagon like peptide-1 GLP-1 receptors in the central nervous system further indirectly regulating the activity of neurons involved in appetite regulation food intake and preference
The previous results of using GLP-1 receptor agonist RA in rats and humans provide promising evidence data to support current randomized clinical trials Peripheral administration of GLP-1 or GLP-1 RA can reduce blood sugar and energy intake in humans and rodents and long-term treatment can lead to weight loss In mice the drug also sustains energy expenditure at levels similar to controls preventing the reduction that normally accompanies caloric restriction Whether the same effects occur in humans is unclear because no studies have yet been performed comparing semaglutide treated individuals with those on a standard calorie restricted diet in effect pair feeding Therefore in this study researchers will use doubly- labelled water DLW and respiratory chambers to investigate whether semaglutide can prevent the reduction of energy expenditure that typically occurs during energy restriction
The previous results of using GLP-1 receptor agonist RA in rats and humans provide promising evidence data to support current randomized clinical trials Peripheral administration of GLP-1 or GLP-1 RA can reduce blood sugar and energy intake in humans and rodents and long-term treatment can lead to weight loss In mice the drug also sustains energy expenditure at levels similar to controls preventing the reduction that normally accompanies caloric restriction Whether the same effects occur in humans is unclear because no studies have yet been performed comparing semaglutide treated individuals with those on a standard calorie restricted diet in effect pair feeding Therefore in this study researchers will use doubly- labelled water DLW and respiratory chambers to investigate whether semaglutide can prevent the reduction of energy expenditure that typically occurs during energy 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