Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu

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

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: NCT02859116
Recruitment Status : Active, not recruiting
First Posted : August 8, 2016
Last Update Posted : October 14, 2020
Sponsor:
Information provided by (Responsible Party):
Translational Research Institute for Metabolism and Diabetes, Florida

Study Description
Go to 
Top of Page Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information
Brief Summary:
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.

Condition or disease Intervention/treatment
Diabetes Procedure: Collection of digestive tissues

Study Design
Go to 
Top of Page Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information

Layout table for study information
Study Type : Observational
Actual Enrollment : 8 participants
Observational Model: Other
Time Perspective: Prospective
Official Title: Collection of Gastrointestinal Tissue Samples for the Characterization and ex Vivo Functional Assessment of Chemoreceptors
Study Start Date : April 2016
Actual Primary Completion Date : September 12, 2018
Estimated Study Completion Date : April 2021
Groups and Cohorts
Go to 
Top of Page Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information

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.


Outcome Measures
Go to 
Top of Page Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information

Primary Outcome Measures :
  1. 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.


Biospecimen Retention:   Samples With DNA
Collection of tissues from the digestive system of patients undergoing surgery for clinical purposes. Tissue samples will be used to assess a mechanism of action (MOA) for the regulation of gut hormone secretion and nutrient absorption. Patients will be also asked to provide clinical/medical data and blood samples prior to their surgery.

Eligibility Criteria
Go to 
Top of Page Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Sampling Method:   Non-Probability Sample
Study Population
Patients undergoing elective gastrointestinal surgical procedures by the surgeons of the Center for Specialized Surgery.
Criteria

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
Contacts and Locations
Go to 
Top of Page Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02859116


Locations
Layout table for location information
United States, Florida
Translational Research Institute for Metabolism and Diabetes
Orlando, Florida, United States, 32804
Sponsors and Collaborators
Translational Research Institute for Metabolism and Diabetes, Florida
Investigators
Layout table for investigator information
Principal Investigator: Richard Pratley, MD Study Principal Investigator
More Information
Go to 
Top of Page Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information
Additional Information:

Publications:

Layout table for additonal information
Responsible Party: Translational Research Institute for Metabolism and Diabetes, Florida
ClinicalTrials.gov Identifier: NCT02859116    
Other Study ID Numbers: TRIMD FH 794609
First Posted: August 8, 2016    Key Record Dates
Last Update Posted: October 14, 2020
Last Verified: October 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Layout table for additional information
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Translational Research Institute for Metabolism and Diabetes, Florida:
Metabolic diseases