Ignite Creation Date:
2025-12-24 @ 7:58 PM
Ignite Modification Date:
2026-01-25 @ 8:37 AM
Study NCT ID:
NCT01694004
Status:
COMPLETED
Last Update Posted:
2024-04-11
First Post:
2012-09-24
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Nutrient Sensing in the Duodenum
Sponsor:
Vanderbilt University Medical Center
Organization:
Study Overview
Official Title:
Duodenal Lipid Sensing and Nutrient Absorption
Status:
COMPLETED
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:
Preliminary studies in humans suggest that the presence of lipids in the gut can modify glucose absorption. The overall hypothesis of this proposal is that long chain fatty acid sensing in the duodenum has a significant role in modifying nutrient (glucose and amino acid) absorption from the GI tract through a gut-brain-gut axis.
Detailed Description:
The investigator will conduct a study in 20 lean (BMI = 19-27 kg/m2) subjects involving intravenous (IV) and intraduodenal (ID) infusions of glucose tracers or amino acid tracers and measurement of tracer rate of appearance in the plasma. An ID infusion of LCFA will allow the investigators to determine if LCFA can alter nutrient absorption and glucose and amino acid metabolism. Benzocaine will be added to the ID infusion of LCFA to inhibit nerve terminals in the duodenum thereby preventing gut-brain communication. Plasma levels of glucose and amino acid tracers, glucose oxidation (13CO2 breath test), gut hormones (CCK, GIP, PYY, GLP-1, ghrelin), and bioactive lipids (N-acyl phosphatidylethanolamines, NAPEs) will be measured during all infusion periods.
Study Oversight
Has Oversight DMC:
False
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?:
False
Is an FDA AA801 Violation?:
Secondary ID Infos
| Secondary ID | Type | Domain | Link | View |
|---|---|---|---|---|
| P30DK058404 | NIH | None | https://reporter.nih.gov/quic… | View |