Clinical trial
Duodenal Lipid Sensing and Nutrient Absorption
Name
IRB #121111
Description
Preliminary studies in humans suggest that the presence of lipids in the gut can modify glucose absorption. The overall hypothesis of this proposal is that long chain fatty acid sensing in the duodenum has a significant role in modifying nutrient (glucose and amino acid) absorption from the GI tract through a gut-brain-gut axis.
Trial arms
Trial start
2012-11-01
Estimated PCD
2014-10-27
Trial end
2014-10-27
Status
Completed
Phase
Early phase I
Treatment
Benzocaine Infusion into Duodenum
Arms:
Benzocaine Infusion into Duodenum
Size
16
Primary endpoint
Nutrient Absorption
6 hours
Eligibility criteria
Inclusion Criteria:
* BMI = 19-27 kg/m2
* 30-55 years of age
Exclusion Criteria:
* Contraindication for nasal tube placement (e.g. deviated 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, Barrett's esophagus
* Type 1 or type 2 diabetes
* Gastroenteritis (diarrhea and/or vomiting) or constipation within the past week
Protocol
{'studyType': 'INTERVENTIONAL', 'phases': ['PHASE1'], 'designInfo': {'allocation': 'NA', 'interventionModel': 'SINGLE_GROUP', 'primaryPurpose': 'BASIC_SCIENCE', 'maskingInfo': {'masking': 'NONE'}}, 'enrollmentInfo': {'count': 16, 'type': 'ACTUAL'}}
Updated at
2024-04-11
1 organization
1 product
1 indication
Organization
Vanderbilt University Medical CenterProduct
Benzocaine