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Role of the Foregut in Nutrient Metabolism in Lean and Obese Humans

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.
 
ClinicalTrials.gov Identifier: NCT02537314
Recruitment Status : Enrolling by invitation
First Posted : September 1, 2015
Last Update Posted : October 3, 2019
Sponsor:
Collaborator:
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
Information provided by (Responsible Party):
Naji Abumrad, Vanderbilt University Medical Center

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.

Condition or disease Intervention/treatment Phase
Obesity Drug: benzocaine Other: placebo Phase 1

Detailed Description:

The study proposes two specific aims Aim 1 will determine if blocking enteric neuronal signaling will alter: a) circulating levels of nutrient substrates and secretion of hormones that regulate nutrient metabolism; and b) glucose and fatty acid absorption, production, and utilization.

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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 45 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Single (Participant)
Primary Purpose: Basic Science
Official Title: Role of the Foregut in Nutrient Metabolism in Lean and Obese Humans
Study Start Date : September 2015
Estimated Primary Completion Date : April 2021
Estimated Study Completion Date : April 2021

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Active Comparator: 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)
Drug: 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)
Other Name: ethyl 4-aminobenzoate

Placebo Comparator: placebo
Placebo (saline) solution administered by intraduodenal infusion one time (6 ml bolus followed by 75 ml/hour for 105 minutes)
Other: placebo
Placebo (saline) solution administered by intraduodenal infusion one time (6 ml bolus followed by 75 ml/hour for 105 minutes)
Other Name: NaCl, sodium chloride




Primary Outcome Measures :
  1. Gastrointestinal Hormones [ Time Frame: 5 Hours ]
    Plasma levels of Cholecystokinin, gastric inhibitory peptide and glucagon like peptide and Ghrelin

  2. Pancreatic Hormones [ Time Frame: 5 Hours ]
    Plasma levels of Insulin, C-peptide, Glucagon

  3. Glucose and Free Fatty Acids [ Time Frame: 5 Hours ]
    Plasma levels


Secondary Outcome Measures :
  1. Glucose Metabolism [ Time Frame: 5 Hours ]
    Glucose tracer kinetics ([3-tritiated] glucose and [U-13C-carbon] oleate)

  2. Fat Metabolism [ Time Frame: 5 Hours ]
    Oleate tracer kinetics ([U-13 C-carbon] oleate)


Other Outcome Measures:
  1. Appetite, Hunger, and GI symptoms [ Time Frame: 5 Hours ]
    Visual Analog Scales (Likert)



Information from the National Library of Medicine

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Ages Eligible for Study:   20 Years to 50 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

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

Exclusion Criteria:

  • 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

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): NCT02537314


Locations
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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
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Principal Investigator: Sinju Sundaresan, PhD Vanderbilt University Medical Center
Principal Investigator: Naji N Abumrad, MD Vanderbilt University Medical Center
Study Director: Kala Dixon, MS Vanderbilt University Medical Center
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Responsible Party: Naji Abumrad, Professor, Vanderbilt University Medical Center
ClinicalTrials.gov Identifier: NCT02537314    
Other Study ID Numbers: 131032
R01DK100431 ( U.S. NIH Grant/Contract )
First Posted: September 1, 2015    Key Record Dates
Last Update Posted: October 3, 2019
Last Verified: May 2019
Keywords provided by Naji Abumrad, Vanderbilt University Medical Center:
Normal Body Weight
Additional relevant MeSH terms:
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Benzocaine
Anesthetics, Local
Anesthetics
Central Nervous System Depressants
Physiological Effects of Drugs
Sensory System Agents
Peripheral Nervous System Agents