Nutrient Sensing in the Duodenum

• Sponsor: Vanderbilt University Medical Center (Other)
• Overall Status: Enrolling by invitation
• CT.gov ID: NCT01694004
• Collaborator: National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK) (NIH)
• Enrollment: 20
• Location: 1
• Arm: 1
• Duration (Months): 122
• Patients Per Site Per Month: 0.2

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
The Effect of LCFA on Nutrient Absorption	Drug: Benzocaine Infusion into Duodenum	Phase 1

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 Design

• Study Type: Interventional
• Anticipated Enrollment: 20 participants
• Allocation: N/A
• Intervention Model: Single Group Assignment
• Masking: None (Open Label)
• Primary Purpose: Basic Science
• Official Title: Duodenal Lipid Sensing and Nutrient Absorption
• Study Start Date: Nov 1, 2012
• Anticipated Primary Completion Date: Jan 1, 2023
• Anticipated Study Completion Date: Jan 1, 2023

Arms and Interventions

Arm

Intervention/Treatment

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

Outcome Measures

Primary Outcome Measures

1. Nutrient Absorption [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.

Secondary Outcome Measures

1. Substrate Oxidation [6 hours]

   Oxidation of intraduodenally administered glucose or amino acid will be determined by the amount of 13C recovered from expired air.

2. Gut Hormone Levels [6 hours]

   Plasma levels of gut hormones will be measured by standard RIA or ELISA assays

Other Outcome Measures

1. Bioactive Lipids [6 hours]

   Plasma levels of N-acyl phosphatidylethanolamines (NAPES)will be measured by LC-MS

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years to 65 Years
• Sexes Eligible for Study: All
• Accepts 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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Vanderbilt University Medical Center	Nashville	Tennessee	United States	37232

Sponsors and Collaborators

• Vanderbilt University Medical Center
• National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)

Investigators

• Principal Investigator: Robyn Tamboli, PhD, Vanderbilt University Medical Center
• Study Director: Naji Abumrad, MD, Vanderbilt University Medical Center

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Robyn Tamboli, Research Assistant Professor, Vanderbilt University Medical Center
• ClinicalTrials.gov Identifier: NCT01694004
• Other Study ID Numbers: IRB #121111; P30DK058404
• First Posted: Sep 26, 2012
• Last Update Posted: Jan 19, 2022
• Last Verified: Jan 1, 2022

• Individual Participant Data (IPD) Sharing Statement: Undecided
• Plan to Share IPD: Undecided
• Studies a U.S. FDA-regulated Drug Product: Yes
• Studies a U.S. FDA-regulated Device Product: No
• Product Manufactured in and Exported from the U.S.: No
• Keywords provided by Robyn Tamboli, Research Assistant Professor, Vanderbilt University Medical Center: Nutrient absorption; Duodenal feeding tube; Gut-brain-gut axis
• Additional relevant MeSH terms: Benzocaine

Study Results

No Results Posted as of Jan 19, 2022