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OpenTrials
Completed

NCT Number: NCT01694004

Nutrient Sensing in the Duodenum

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.

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Key information

Conditions

The Effect of LCFA on Nutrient Absorption

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

Vanderbilt University Medical Center

Nashville, Tennessee, 37232, United States

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Benzocaine Infusion into Duodenum

Drug

Primary outcomes

  1. 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 outcomes

  1. 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.

  2. Gut Hormone Levels

    Time frame: 6 hours

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

Other outcomes

  1. Bioactive Lipids

    Time frame: 6 hours

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

Sponsors and collaborators

Lead sponsor

Vanderbilt University Medical Center

Other

Collaborators

  • National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)

Registry information

Official study title

Duodenal Lipid Sensing and Nutrient Absorption

Important dates

Study start
2012
Primary completion
2014
Study completion
2014
First posted
Sep 26, 2012
Registry last updated
Apr 11, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.