Expired Study
This study is not currently recruiting Study Participants on ClinicalConnection.com. If you would like to find active studies please search for clinical trials.

Nashville, Tennessee 37232


Purpose:

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.


Study summary:

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.


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


Study is Available At:


Original ID:

131032


NCT ID:

NCT02537314


Secondary ID:

R01DK100431


Study Acronym:


Brief Title:

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


Official Title:

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


Overall Status:

Enrolling by invitation


Study Phase:

Phase 1


Genders:

N/A


Minimum Age:

20 Years


Maximum Age:

50 Years


Quick Facts

Healthy Volunteers
Oversight Has DMC
Study Is FDA Regulated
Study Is Section 801
Has Expanded Access

Study Source:

Vanderbilt University Medical Center


Oversight Authority:

United States: Food and Drug Administration


Reasons Why Stopped:


Study Type:

Interventional


Study Design:


Number of Arms:

2


Number of Groups:

0


Total Enrollment:

45


Enrollment Type:

Anticipated


Overall Contact Information

Official Name:Sinju Sundaresan, PhD
Principal Investigator
Vanderbilt University Medical Center

Study Dates

Start Date:September 2015
Completion Date:April 2021
Completion Type:Anticipated
Primary Completion Date:April 2021
Primary Completion Type:Anticipated
Verification Date:May 2019
Last Changed Date:October 2, 2019
First Received Date:August 25, 2015

Study Outcomes

Outcome Type:Primary Outcome
Measure:Gastrointestinal Hormones
Time Frame:5 Hours
Safety Issues:False
Description:Plasma levels of Cholecystokinin, gastric inhibitory peptide and glucagon like peptide and Ghrelin
Outcome Type:Primary Outcome
Measure:Pancreatic Hormones
Time Frame:5 Hours
Safety Issues:False
Description:Plasma levels of Insulin, C-peptide, Glucagon
Outcome Type:Primary Outcome
Measure:Glucose and Free Fatty Acids
Time Frame:5 Hours
Safety Issues:False
Description:Plasma levels
Outcome Type:Secondary Outcome
Measure:Glucose Metabolism
Time Frame:5 Hours
Safety Issues:False
Description:Glucose tracer kinetics ([3-tritiated] glucose and [U-13C-carbon] oleate)
Outcome Type:Secondary Outcome
Measure:Fat Metabolism
Time Frame:5 Hours
Safety Issues:False
Description:Oleate tracer kinetics ([U-13 C-carbon] oleate)

Study Interventions

Intervention Type:Drug
Name:benzocaine
Description: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)
Arm Name:benzocaine
Other Name:ethyl 4-aminobenzoate
Intervention Type:Other
Name:placebo
Description:Placebo (saline) solution administered by intraduodenal infusion one time (6 ml bolus followed by 75 ml/hour for 105 minutes)
Arm Name:placebo
Other Name:NaCl, sodium chloride

Study Arms

Study Arm Type:Active Comparator
Arm Name:benzocaine
Description: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)
Study Arm Type:Placebo Comparator
Arm Name:placebo
Description:Placebo (saline) solution administered by intraduodenal infusion one time (6 ml bolus followed by 75 ml/hour for 105 minutes)

Study Agencies

Agency Class:Other
Agency Type:Lead Sponsor
Agency Name:Vanderbilt University Medical Center
Agency Class:NIH
Agency Type:Collaborator
Agency Name:National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)

Sample and Retention Information

There are no available Sample and Retention Information

Study References

There are no available Study References

Data Source: ClinicalTrials.gov

Date Processed: January 21, 2020

Modifications to this listing: Only selected fields are shown, please use the link below to view all information about this clinical trial.


This study is not currently recruiting Study Participants. The form below is not enabled.