NCT02537314

Brief Summary

The overall hypothesis of this proposal is that nutrient sensing in the foregut regulates metabolic hormone secretion and nutrient metabolism via enteric neural signals, and these mechanisms might be defective in obesity.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
27

participants targeted

Target at P25-P50 for phase_1 obesity

Timeline
Completed

Started Sep 2015

Longer than P75 for phase_1 obesity

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

August 25, 2015

Completed
7 days until next milestone

First Posted

Study publicly available on registry

September 1, 2015

Completed
Same day until next milestone

Study Start

First participant enrolled

September 1, 2015

Completed
7.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 8, 2022

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 8, 2022

Completed
Last Updated

December 9, 2022

Status Verified

December 1, 2022

Enrollment Period

7.3 years

First QC Date

August 25, 2015

Last Update Submit

December 8, 2022

Conditions

Obesity

Keywords

Normal Body Weight

Outcome Measures

Primary Outcomes (3)

  • Gastrointestinal Hormones

    Plasma levels of Cholecystokinin, gastric inhibitory peptide and glucagon like peptide and Ghrelin

    5 Hours

  • Pancreatic Hormones

    Plasma levels of Insulin, C-peptide, Glucagon

    5 Hours

  • Glucose and Free Fatty Acids

    Plasma levels

    5 Hours

Secondary Outcomes (2)

  • Glucose Metabolism

    5 Hours

  • Fat Metabolism

    5 Hours

Other Outcomes (1)

  • Appetite, Hunger, and GI symptoms

    5 Hours

Study Arms (2)

benzocaine

ACTIVE COMPARATOR

0.5% benzocaine solution in saline/hydrochloric acid administered by intraduodenal infusion one time (6 ml bolus followed by 75 ml/hour for 105 minutes)

Drug: benzocaine

placebo

PLACEBO COMPARATOR

Placebo (saline) solution administered by intraduodenal infusion one time (6 ml bolus followed by 75 ml/hour for 105 minutes)

Other: placebo

Interventions

benzocaineDRUG

0.5% benzocaine solution in saline/hydrochloric acid administered by intraduodenal infusion one time (6 ml bolus followed by 75 ml/hour for 105 minutes)

Also known as: ethyl 4-aminobenzoate
benzocaine
placeboOTHER

Placebo (saline) solution administered by intraduodenal infusion one time (6 ml bolus followed by 75 ml/hour for 105 minutes)

Also known as: NaCl, sodium chloride
placebo

Eligibility Criteria

Age20 Years - 50 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • BMI 19 - 25 kg/m2 or 30 - 50 kg/m2
  • Age 20 - 50 years

You may not qualify if:

  • Contraindication to a nasoduodenal feeding tube (e.g., deviated nasal 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
  • Type 1 or type 2 diabetes
  • Recent presence of or treatment for gastroenteritis (diarrhea and/or vomiting), constipation, or upper respiratory infection
  • Anemia
  • Abnormal electrocardiogram
  • Prior adverse reaction to anesthesia
  • Tobacco use

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Vanderbilt University Medical Center

Nashville, Tennessee, 37232, United States

Location

Related Publications (1)

  • Sundaresan S, Johnson C, Dixon KB, Dole M, Kilkelly D, Antoun J, Flynn CR, Abumrad NN, Tamboli R. Intraduodenal nutrient infusion differentially alters intestinal nutrient sensing, appetite, and satiety responses in lean and obese subjects. Am J Clin Nutr. 2023 Sep;118(3):646-656. doi: 10.1016/j.ajcnut.2023.06.011. Epub 2023 Aug 8.

    PMID: 37661107DERIVED

MeSH Terms

Conditions

Obesity

Interventions

BenzocaineSodium Chloride

Condition Hierarchy (Ancestors)

OverweightOvernutritionNutrition DisordersNutritional and Metabolic DiseasesBody WeightSigns and SymptomsPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

para-AminobenzoatesAminobenzoatesBenzoatesAcids, CarbocyclicCarboxylic AcidsOrganic ChemicalsBenzene DerivativesHydrocarbons, AromaticHydrocarbons, CyclicHydrocarbonsChloridesHydrochloric AcidChlorine CompoundsInorganic ChemicalsSodium Compounds

Study Officials

  • Sinju Sundaresan, PhD

    Vanderbilt University Medical Center

    PRINCIPAL INVESTIGATOR

  • Naji N Abumrad, MD

    Vanderbilt University Medical Center

    PRINCIPAL INVESTIGATOR

  • Kala Dixon, MS

    Vanderbilt University Medical Center

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
phase 1
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
BASIC SCIENCE
Intervention Model
CROSSOVER
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor

Study Record Dates

First Submitted

August 25, 2015

First Posted

September 1, 2015

Study Start

September 1, 2015

Primary Completion

December 8, 2022

Study Completion

December 8, 2022

Last Updated

December 9, 2022

Record last verified: 2022-12

Locations

US(1)