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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

Tracking Information
First Submitted Date  ICMJE August 25, 2015
First Posted Date  ICMJE September 1, 2015
Last Update Posted Date October 3, 2019
Study Start Date  ICMJE September 2015
Estimated Primary Completion Date April 2021   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: May 8, 2019)
  • Gastrointestinal Hormones [ Time Frame: 5 Hours ]
    Plasma levels of Cholecystokinin, gastric inhibitory peptide and glucagon like peptide and Ghrelin
  • Pancreatic Hormones [ Time Frame: 5 Hours ]
    Plasma levels of Insulin, C-peptide, Glucagon
  • Glucose and Free Fatty Acids [ Time Frame: 5 Hours ]
    Plasma levels
Original Primary Outcome Measures  ICMJE
 (submitted: August 31, 2015)
  • Gastrointestinal Hormones [ Time Frame: 5 hours ]
    Plasma levels of CCK, GIP, GLP-1, Ghrelin
  • Pancreatic Hormones [ Time Frame: 5 hours ]
    Plasma levels of Insulin, C-peptide, Glucagon
  • Glucose and FFA [ Time Frame: 5 hours ]
    Plasma levels
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: May 8, 2019)
  • Glucose Metabolism [ Time Frame: 5 Hours ]
    Glucose tracer kinetics ([3-tritiated] glucose and [U-13C-carbon] oleate)
  • Fat Metabolism [ Time Frame: 5 Hours ]
    Oleate tracer kinetics ([U-13 C-carbon] oleate)
Original Secondary Outcome Measures  ICMJE
 (submitted: August 31, 2015)
  • Glucose Metabolism [ Time Frame: 5 hours ]
    Glucose isotopic tracer kinetics ([3-3H] glucose and [U-14C6] glucose)
  • Fat Metabolism [ Time Frame: 5 hours ]
    Oleate isotopic tracer kinetics ([9,10-2H2] oleate and [U-13C] oleate)
Current Other Pre-specified Outcome Measures
 (submitted: September 8, 2016)
Appetite, Hunger, and GI symptoms [ Time Frame: 5 Hours ]
Visual Analog Scales (Likert)
Original Other Pre-specified Outcome Measures
 (submitted: August 31, 2015)
Appetite, Hunger, and GI symptoms [ Time Frame: 5 hours ]
Visual Analog Scales (Likert)
 
Descriptive Information
Brief Title  ICMJE Role of the Foregut in Nutrient Metabolism in Lean and Obese Humans
Official Title  ICMJE Role of the Foregut in Nutrient Metabolism in Lean and Obese Humans
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.
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.

Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 1
Study Design  ICMJE Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Single (Participant)
Primary Purpose: Basic Science
Condition  ICMJE Obesity
Intervention  ICMJE
  • 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
  • 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
Study Arms  ICMJE
  • 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)
    Intervention: Drug: benzocaine
  • Placebo Comparator: placebo
    Placebo (saline) solution administered by intraduodenal infusion one time (6 ml bolus followed by 75 ml/hour for 105 minutes)
    Intervention: Other: placebo
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Enrolling by invitation
Estimated Enrollment  ICMJE
 (submitted: May 18, 2018)
45
Original Estimated Enrollment  ICMJE
 (submitted: August 31, 2015)
34
Estimated Study Completion Date  ICMJE April 2021
Estimated Primary Completion Date April 2021   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 20 Years to 50 Years   (Adult)
Accepts Healthy Volunteers  ICMJE Yes
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT02537314
Other Study ID Numbers  ICMJE 131032
R01DK100431 ( U.S. NIH Grant/Contract )
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Naji Abumrad, Vanderbilt University Medical Center
Study Sponsor  ICMJE Vanderbilt University Medical Center
Collaborators  ICMJE National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
Investigators  ICMJE
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
PRS Account Vanderbilt University Medical Center
Verification Date May 2019

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP