Nutrient Sensing in the Duodenum
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|ClinicalTrials.gov Identifier: NCT01694004|
Recruitment Status : Enrolling by invitation
First Posted : September 26, 2012
Last Update Posted : January 25, 2018
|Condition or disease||Intervention/treatment||Phase|
|The Effect of LCFA on Nutrient Absorption||Drug: Benzocaine Infusion into Duodenum||Phase 1|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||20 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Primary Purpose:||Basic Science|
|Official Title:||Duodenal Lipid Sensing and Nutrient Absorption|
|Study Start Date :||November 2012|
|Estimated Primary Completion Date :||December 2018|
|Estimated Study Completion Date :||December 2018|
Experimental: Benzocaine Infusion into Duodenum
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 traces 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.
Drug: Benzocaine Infusion into Duodenum
- Nutrient Absorption [ Time Frame: 6 hours ]Stable 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.
- Substrate Oxidation [ Time Frame: 6 hours ]Oxidation of intraduodenally administered glucose or amino acid will be determined by the amount of 13C recovered from expired air.
- Gut Hormone Levels [ Time Frame: 6 hours ]Plasma levels of gut hormones will be measured by standard RIA or ELISA assays
- Bioactive Lipids [ Time Frame: 6 hours ]Plasma levels of N-acyl phosphatidylethanolamines (NAPES)will be measured by LC-MS
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01694004
|United States, Tennessee|
|Vanderbilt University Medical Center|
|Nashville, Tennessee, United States, 37232|
|Principal Investigator:||Robyn Tamboli, PhD||Vanderbilt University Medical Center|
|Study Director:||Naji Abumrad, MD||Vanderbilt University Medical Center|