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Nutrient Sensing in the Duodenum

Duodenal Lipid Sensing and Nutrient Absorption

Status
Completed
Phases
Phase 1
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT01694004
Enrollment
16
Registered
2012-09-26
Start date
2012-11-30
Completion date
2014-10-27
Last updated
2024-04-11

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

The Effect of LCFA on Nutrient Absorption

Keywords

Nutrient absorption, Duodenal feeding tube, Gut-brain-gut axis

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.

Interventions

DRUGBenzocaine Infusion into Duodenum

Sponsors

National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
CollaboratorNIH
Vanderbilt University Medical Center
Lead SponsorOTHER

Study design

Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
BASIC_SCIENCE
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
18 Years to 65 Years
Healthy volunteers
Yes

Inclusion criteria

* BMI = 19-27 kg/m2 * 30-55 years of age

Exclusion criteria

* Contraindication for nasal tube placement (e.g. deviated septum, prior upper gastrointestinal bleed, or history of easy bleeding) * Prior gastric or intestinal surgery or pancreas resection * Females with a positive pregnancy test * Known history of intestinal diseases including (but not limited to) inflammatory bowel disease (e.g. ulcerative colitis, Crohn's disease), celiac sprue, Barrett's esophagus * Type 1 or type 2 diabetes * Gastroenteritis (diarrhea and/or vomiting) or constipation within the past week

Design outcomes

Primary

MeasureTime frameDescription
Nutrient Absorption6 hoursStable isotope tracers (glucose or amino acid) will be administered intravenously (IV) and intraduodenally (ID) and tracer rate of appearance in the plasma will be measured.

Secondary

MeasureTime frameDescription
Substrate Oxidation6 hoursOxidation of intraduodenally administered glucose or amino acid will be determined by the amount of 13C recovered from expired air.
Gut Hormone Levels6 hoursPlasma levels of gut hormones will be measured by standard RIA or ELISA assays

Other

MeasureTime frameDescription
Bioactive Lipids6 hoursPlasma levels of N-acyl phosphatidylethanolamines (NAPES)will be measured by LC-MS

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026