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Local Anesthetic

Duodenal Benzocaine Infusion for Diabetes

Phase 1
Waitlist Available
Led By Robyn Tamboli, PhD
Research Sponsored by Vanderbilt University Medical Center
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
BMI = 19-27 kg/m2
30-55 years of age
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 6 hours
Awards & highlights

Study Summary

This trial will test if a new drug that reduces fat in the gut can help control blood sugar levels in people with diabetes.

Who is the study for?
This trial is for adults aged 30-55 with a BMI of 19-27 kg/m2. It's not suitable for those who've had recent gastroenteritis or constipation, any past gut surgery, intestinal diseases like IBD or celiac disease, pregnant women, diabetics, or anyone who can't have a nasal tube placed due to medical reasons.Check my eligibility
What is being tested?
The study tests how benzocaine infusion into the duodenum affects nutrient absorption by potentially altering glucose and amino acid levels. The idea is that fatty acids in the gut might communicate with the brain to regulate this process.See study design
What are the potential side effects?
While specific side effects are not listed here, typical reactions to benzocaine could include local irritation where infused, potential numbness in the area due to its anesthetic properties, and allergic reactions.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
Select...
Your body mass index (BMI) falls within the range of 19 to 27 kg/m2.
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You are between 30 and 55 years old.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~6 hours
This trial's timeline: 3 weeks for screening, Varies for treatment, and 6 hours for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Nutrient Absorption
Secondary outcome measures
Gut Hormone Levels
Substrate Oxidation
Other outcome measures
Bioactive Lipids

Trial Design

1Treatment groups
Experimental Treatment
Group I: Benzocaine Infusion into DuodenumExperimental Treatment1 Intervention
The investigator will conduct a study in 20 lean (BMI = 19-27 kg/m2) subjects involving intravenous (IV) and intraduodenal (ID) infusions of glucose tracers or amino acid traces and measurement of tracer rate of appearance in the plasma. An ID infusion of LCFA will allow the investigators to determine if LCFA can alter nutrient absorption and glucose and amino acid metabolism. Benzocaine will be added to the ID infusion of LCFA to inhibit nerve terminals in the duodenum thereby preventing gut-brain communication. Plasma levels of glucose and amino acid tracers, glucose oxidation (13CO2 breath test), gut hormones (CCK, GIP, PYY, GLP-1, ghrelin), and bioactive lipids (N-acyl phosphatidylethanolamines, NAPEs) will be measured during all infusion periods.

Find a Location

Logistics

Participation is compensated

You will be compensated for participating in this trial.

Who is running the clinical trial?

Vanderbilt University Medical CenterLead Sponsor
850 Previous Clinical Trials
669,107 Total Patients Enrolled
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)NIH
2,338 Previous Clinical Trials
4,314,179 Total Patients Enrolled
Robyn Tamboli, PhDPrincipal InvestigatorVanderbilt University Medical Center
2 Previous Clinical Trials
82 Total Patients Enrolled

Media Library

Benzocaine (Local Anesthetic) Clinical Trial Eligibility Overview. Trial Name: NCT01694004 — Phase 1
Long-Chain Fatty Acid Malabsorption Research Study Groups: Benzocaine Infusion into Duodenum
Long-Chain Fatty Acid Malabsorption Clinical Trial 2023: Benzocaine Highlights & Side Effects. Trial Name: NCT01694004 — Phase 1
Benzocaine (Local Anesthetic) 2023 Treatment Timeline for Medical Study. Trial Name: NCT01694004 — Phase 1

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

For what conditions is Benzocaine Infusion into Duodenum a viable treatment option?

"The infusion of benzocaine into the duodenum is frequently used to alleviate laryngitis. It also has been demonstrated efficacious in treating sequelae caused by tonsillectomy, ulcers, and nausea-induced vomiting."

Answered by AI

Are individuals aged 25 and older being welcomed to join the research project?

"This clinical trial seeks participants that are of legal age, but younger than 65 years old."

Answered by AI

What is the upper threshold of participants for this trial?

"This trial has concluded its recruitment process, as the information was last updated on January 18th 2022. However, alternative studies are recruiting; 1 study is looking into lcfa's effect on nutrient absorption and 2 trials have opened for Benzocaine Infusion into Duodenum participants."

Answered by AI

Are there reports of prior experiments using Benzocaine Infusion into the Duodenum?

"Presently, there are two distinct investigations into the efficacy of Benzocaine Infusion into Duodenum currently in progress. Neither have reached Phase 3 yet and most of them are situated in Nashville, Tennessee; however, research is also occurring at 2 other sites as well."

Answered by AI

Has the FDA granted acceptance to infusing Benzocaine into the duodenum?

"This experimental intervention has only been subjected to a limited amount of safety testing, thus it was given an assessment of 1."

Answered by AI

Does this research endeavor currently have any open enrollment?

"Unfortunately, this investigation is no longer recruiting participants. According to the information found on clinicaltrials.gov, it was initially posted in November 2012 and last modified in January 2022; however, there are 3 other trials actively enrolling patients presently."

Answered by AI

Does my profile meet the criterion to be part of this research?

"To qualify for this medical trial, candidates must have lcfa-induced nutrient malabsorption and be of legal age (18 - 65). This clinical research is seeking to enrol a total of 20 participants."

Answered by AI
~2 spots leftby Mar 2025