Role of the Foregut in Nutrient Metabolism in Lean and Obese Humans
NCT ID: NCT02537314
Last Updated: 2022-12-09
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE1
27 participants
INTERVENTIONAL
2015-09-30
2022-12-08
Brief Summary
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Detailed Description
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Obese (BMI = 30-50 kg/m2) subjects will be studied. The topical anesthetic benzocaine will be infused into the duodenum prior to infusion of glucose and oleic acid into the duodenum. Duodenal infusions with a naso-intestinal feeding tube will circumvent the confounding effects of gastric emptying on the metabolic responses to a meal. Substrates (glucose, free fatty acids), and lipoproteins) and hormones will be measured by standard biochemical and immunological methods. Aim 2 will determine if enteric neural signals regulate appetite. The studies will be carried out in both lean and obese humans and the procedure will be performed as described above. In addition, the subjects will be asked to use a visual analog scale to estimate their level of appetite before, during and after enteral infusions.
Conditions
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Keywords
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Study Design
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RANDOMIZED
CROSSOVER
BASIC_SCIENCE
SINGLE
Study Groups
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benzocaine
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)
benzocaine
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)
placebo
Placebo (saline) solution administered by intraduodenal infusion one time (6 ml bolus followed by 75 ml/hour for 105 minutes)
placebo
Placebo (saline) solution administered by intraduodenal infusion one time (6 ml bolus followed by 75 ml/hour for 105 minutes)
Interventions
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benzocaine
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)
placebo
Placebo (saline) solution administered by intraduodenal infusion one time (6 ml bolus followed by 75 ml/hour for 105 minutes)
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* Age 20 - 50 years
Exclusion Criteria
* 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
20 Years
50 Years
ALL
Yes
Sponsors
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National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
NIH
Vanderbilt University Medical Center
OTHER
Responsible Party
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Naji Abumrad
Professor
Principal Investigators
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Sinju Sundaresan, PhD
Role: PRINCIPAL_INVESTIGATOR
Vanderbilt University Medical Center
Naji N Abumrad, MD
Role: PRINCIPAL_INVESTIGATOR
Vanderbilt University Medical Center
Kala Dixon, MS
Role: STUDY_DIRECTOR
Vanderbilt University Medical Center
Locations
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Vanderbilt University Medical Center
Nashville, Tennessee, United States
Countries
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References
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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.
Other Identifiers
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131032
Identifier Type: -
Identifier Source: org_study_id