Ignite Creation Date:
2024-05-05 @ 11:45 AM
Last Modification Date:
2024-10-26 @ 9:12 AM
Study NCT ID:
NCT00121433
Status:
COMPLETED
Last Update Posted:
2006-06-27
First Post:
2005-07-13
Brief Title:
Leptin and Endothelial Function
Sponsor:
University of Michigan
Organization:
University of Michigan
Study Overview
Official Title:
The Role of Leptin in Modulating Vascular Tone and Endothelial Function in Obese and Normal Weight Adults A Vascular-Protective Effect of Leptin
Status:
COMPLETED
Status Verified Date:
2005-07
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 trial was to determine if injections of leptin would improve vascular function in normal-weight healthy volunteers
Detailed Description:
The researchers plan to enroll a total of 15 non-obese BMI 27 kgm2 otherwise healthy adults into a randomized double-blinded cross-over study of the impact of recombinant methionyl human leptin 02 mgkg SC hereafter called rL Amgen Inc Thousand Oaks Calif versus placebo SC sorbitol and sodium acetate pH 40 of same volume in 15 non-obese adults Subjects will have baseline vascular studies performed by brachial artery ultrasonography-flow-mediated dilatation and nitroglycerin mediated dilatation and blood drawn for measures of leptin levels They will then receive rL SC or placebo SC randomized order They will then have vascular studies performed and blood levels drawn every 2 hours for 6 hours total After completion of day 1 patients will return 1-4 weeks later and repeat the protocol crossed-over to the alternate intervention rL or placebo
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
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| IRB 2003-0383 | None | None | None |
| GCRC 1955 | None | None | None |