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Nutrient Sensing in the Duodenum

This study is enrolling participants by invitation only.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01694004
First Posted: September 26, 2012
Last Update Posted: January 24, 2017
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Collaborator:
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
Information provided by (Responsible Party):
Robyn Tamboli, Vanderbilt University Medical Center
  Purpose
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 Intervention Phase
The Effect of LCFA on Nutrient Absorption Drug: Benzocaine Infusion into Duodenum Phase 1

Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Basic Science
Official Title: Duodenal Lipid Sensing and Nutrient Absorption

Resource links provided by NLM:


Further study details as provided by Robyn Tamboli, Vanderbilt University Medical Center:

Primary Outcome Measures:
  • 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.


Secondary Outcome Measures:
  • 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


Other Outcome Measures:
  • Bioactive Lipids [ Time Frame: 6 hours ]
    Plasma levels of N-acyl phosphatidylethanolamines (NAPES)will be measured by LC-MS


Estimated Enrollment: 20
Study Start Date: November 2012
Estimated Study Completion Date: December 2017
Estimated Primary Completion Date: December 2017 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

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.
  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 65 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

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
Information from the National Library of Medicine

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


Locations
United States, Tennessee
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
  More Information

Responsible Party: Robyn Tamboli, Research Assistant Professor, Vanderbilt University Medical Center
ClinicalTrials.gov Identifier: NCT01694004     History of Changes
Other Study ID Numbers: IRB #121111
P30DK058404 ( U.S. NIH Grant/Contract )
First Submitted: September 24, 2012
First Posted: September 26, 2012
Last Update Posted: January 24, 2017
Last Verified: January 2017
Individual Participant Data (IPD) Sharing Statement:
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, Vanderbilt University Medical Center:
Nutrient absorption
Duodenal feeding tube
Gut-brain-gut axis

Additional relevant MeSH terms:
Benzocaine
Anesthetics, Local
Anesthetics
Central Nervous System Depressants
Physiological Effects of Drugs
Sensory System Agents
Peripheral Nervous System Agents