Collection of Gastrointestinal Tissue Samples for the Characterization and ex Vivo Functional Assessment of Chemoreceptors (ISTAR-T)

August 2, 2022 updated by: AdventHealth Translational Research Institute
The purpose of this study is to help scientists understand how the gut senses ingested nutrients and what kind of processes take place for their absorption in order to establish the association with diabetes and other metabolic diseases Scientists need human specimens to study.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Actual)

8

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Florida
      • Orlando, Florida, United States, 32804
        • Translational Research Institute for Metabolism and Diabetes

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

16 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

Patients undergoing elective gastrointestinal surgical procedures by the surgeons of the Center for Specialized Surgery.

Description

Inclusion Criteria:

  1. Men and women age 18 years and older who are having elective gastrointestinal surgery
  2. Able to provide written, informed consent

Exclusion Criteria:

  1. Unable to provide written, informed consent
  2. Use of antibiotics for more than 5 consecutive days in the three months prior to the study

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Other
  • Time Perspectives: Prospective

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Collection of digestive tissues
Digestive tissues will be collected from participants undergoing scheduled (non-emergent) gastrointestinal surgery.
Procedure: Collection of digestive tissues
The surgeon will resect a sample (approximately 1-5 cm x 1-5 cm) of healthy tissue from the distal margins of the segment and at least 4 cm from the diseased area. The specimen for research will be obtained from the tissue that would ordinarily be removed during surgery.The tissue collected for our research purposes will be only remnant tissue which is discarded by the surgeon during the surgical intervention and has no diagnostic clinical value.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Tissue collection
Time Frame: Day of surgery
During surgery, a tissue specimen that would normally be discarded, will be obtained and used to identify the localization and amount of different proteins that regulate nutrient absorption.
Day of surgery

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

AdventHealth Translational Research Institute

Investigators

  • Principal Investigator: Richard Pratley, MD, Study Principal Investigator

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

July 21, 2016

Primary Completion (Actual)

September 12, 2018

Study Completion (Actual)

January 21, 2022

Study Registration Dates

First Submitted

July 13, 2016

First Submitted That Met QC Criteria

August 3, 2016

First Posted (Estimate)

August 8, 2016

Study Record Updates

Last Update Posted (Actual)

August 3, 2022

Last Update Submitted That Met QC Criteria

August 2, 2022

Last Verified

August 1, 2022

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • TRIMD FH 794609

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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