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
|Condition or disease||Intervention/treatment|
|Diabetes||Procedure: Collection of digestive tissues|
|Study Type :||Observational|
|Actual Enrollment :||8 participants|
|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|
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.
- 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
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
|United States, Florida|
|Translational Research Institute for Metabolism and Diabetes|
|Orlando, Florida, United States, 32804|
|Principal Investigator:||Richard Pratley, MD||Study Principal Investigator|