Nutrient Sensing in the Duodenum

This study is enrolling participants by invitation only.
Sponsor:
Information provided by (Responsible Party):
Robyn Tamboli, Vanderbilt University
ClinicalTrials.gov Identifier:
NCT01694004
First received: September 24, 2012
Last updated: November 6, 2013
Last verified: November 2013
  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
The Effect of LCFA on Nutrient Absorption
Procedure: Placement of naso-duodenal tube and infusions

Study Type: Observational
Study Design: Observational Model: Case-Only
Time Perspective: Prospective
Official Title: Duodenal Lipid Sensing and Nutrient Absorption

Further study details as provided by Vanderbilt University:

Primary Outcome Measures:
  • Nutrient Absorption [ Time Frame: 2 yrs ] [ Designated as safety issue: No ]
    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: 2 years ] [ Designated as safety issue: No ]
    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: 2 years ] [ Designated as safety issue: No ]
    Plasma levels of gut hormones will be measured by standard RIA or ELISA assays


Other Outcome Measures:
  • Bioactive Lipids [ Time Frame: 2 years ] [ Designated as safety issue: No ]
    Plasma levels of N-acyl phosphatidylethanolamines (NAPES)will be measured by LC-MS


Biospecimen Retention:   Samples With DNA

Plasma


Estimated Enrollment: 20
Study Start Date: November 2012
Estimated Study Completion Date: June 2014
Estimated Primary Completion Date: June 2014 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
LCFA effects on glucose and amino acid absorption
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.
Procedure: Placement of naso-duodenal tube and infusions

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

Ages Eligible for Study:   18 Years to 65 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Sampling Method:   Non-Probability Sample
Study Population

Residents within and near Nashville, TN

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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01694004

Locations
United States, Tennessee
Vanderbilt University Medical Center
Nashville, Tennessee, United States, 37232
Sponsors and Collaborators
Vanderbilt University
  More Information

No publications provided

Responsible Party: Robyn Tamboli, Research Assistant Professor, Vanderbilt University
ClinicalTrials.gov Identifier: NCT01694004     History of Changes
Other Study ID Numbers: IRB #121111, P30DK058404
Study First Received: September 24, 2012
Last Updated: November 6, 2013
Health Authority: United States: Food and Drug Administration

Keywords provided by Vanderbilt University:
Nutrient absorption
Duodenal feeding tube
Gut-brain-gut axis

ClinicalTrials.gov processed this record on September 11, 2014