Ignite Creation Date:
2024-05-06 @ 11:21 AM
Last Modification Date:
2024-10-26 @ 12:44 PM
Study NCT ID:
NCT03497988
Status:
WITHDRAWN
Last Update Posted:
2018-12-26
First Post:
2018-03-19
Brief Title:
Intranasal Oxytocin and Food Intake in Obese Adolescents
Sponsor:
Shana McCormack MD
Organization:
Childrens Hospital of Philadelphia
Study Overview
Official Title:
Effect of a Single Dose of Intranasal Oxytocin on Food Intake in Obese Adolescents
Status:
WITHDRAWN
Status Verified Date:
2018-12
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Grant proposal not funded study has been withdrawn with IRB
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
The purpose of the study is to determine the effect of intranasal OXT caloric intake and eating behaviors in otherwise healthy obese adolescents
The primary objective of this study is to determine the effects of intranasal administration of oxytocin on food intake in obese pubertal or post-pubertal adolescents 13 to 18 years in girls and 15 to 20 years in boys
The primary objective of this study is to determine the effects of intranasal administration of oxytocin on food intake in obese pubertal or post-pubertal adolescents 13 to 18 years in girls and 15 to 20 years in boys
Detailed Description:
Participants will undergo a telephone screening and then within 4 weeks complete an in-person screening visit to determine eligibility Then within 4 weeks they will be randomized to either OXT or placebo After a minimum 1-week 7-28 days washout participants will cross-over to treatment with the other condition ie placebo or OXT
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
True
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