Ignite Creation Date:
2024-05-05 @ 11:49 AM
Last Modification Date:
2024-10-26 @ 9:14 AM
Study NCT ID:
NCT00140205
Status:
COMPLETED
Last Update Posted:
2018-11-02
First Post:
2005-08-30
Brief Title:
Pharmacokinetics of Leptin Administration During Fasting
Sponsor:
Beth Israel Deaconess Medical Center
Organization:
Beth Israel Deaconess Medical Center
Study Overview
Official Title:
Pharmacokinetics of Leptin Administration During Fasting
Status:
COMPLETED
Status Verified Date:
2017-05
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:
None
Brief Summary:
The purpose of this study will be to determine the correct dose of leptin a natural hormone secreted by the fat cells to give to people when they are fasting and also to determine whether giving leptin to a person when he or she is fasting will reverse the changes in hormone levels that occur with fasting
Detailed Description:
Leptin is a newly-identified hormone secreted by fat cells under normal conditions that acts in the brain to decrease appetite and increase long term energy usage Leptin levels usually go down when people are not eating for extended periods of time Changes in metabolism and certain hormone levels also occur with fasting By studying the pharmacokinetics of leptin administration we can evaluate the changes of leptin levels in response to giving different doses of leptin as well as acute changes of other hormones in response to leptin levels Investigations such as this one have important implications for the future therapeutic use of leptin including determining the appropriate dose of leptin to use in future studies involving leptin administration
Comparison subjects receiving leptin at 3 different doses in the fed state compared to the fasting state
Comparison subjects receiving leptin at 3 different doses in the fed state compared to the fasting state
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