NCT02859116

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
8

participants targeted

Target at below P25 for all trials

Timeline
Completed

Started Jul 2016

Longer than P75 for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

July 13, 2016

Completed
8 days until next milestone

Study Start

First participant enrolled

July 21, 2016

Completed
18 days until next milestone

First Posted

Study publicly available on registry

August 8, 2016

Completed
2.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 12, 2018

Completed
3.4 years until next milestone

Study Completion

Last participant's last visit for all outcomes

January 21, 2022

Completed
Last Updated

August 3, 2022

Status Verified

August 1, 2022

Enrollment Period

2.1 years

First QC Date

July 13, 2016

Last Update Submit

August 2, 2022

Conditions

Diabetes

Keywords

Metabolic diseases

Outcome Measures

Primary Outcomes (1)

  • Tissue collection

    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

Study Arms (1)

Collection of digestive tissues

Digestive tissues will be collected from participants undergoing scheduled (non-emergent) gastrointestinal surgery.

Procedure: Collection of digestive tissues

Interventions

Collection of digestive tissuesPROCEDURE

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.

Collection of digestive tissues

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

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

You may qualify if:

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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Translational Research Institute for Metabolism and Diabetes

Orlando, Florida, 32804, United States

Location

Related Publications (18)

  • Adler E, Hoon MA, Mueller KL, Chandrashekar J, Ryba NJ, Zuker CS. A novel family of mammalian taste receptors. Cell. 2000 Mar 17;100(6):693-702. doi: 10.1016/s0092-8674(00)80705-9.

    PMID: 10761934BACKGROUND

  • Chandrashekar J, Hoon MA, Ryba NJ, Zuker CS. The receptors and cells for mammalian taste. Nature. 2006 Nov 16;444(7117):288-94. doi: 10.1038/nature05401.

    PMID: 17108952BACKGROUND

  • Chandrashekar J, Mueller KL, Hoon MA, Adler E, Feng L, Guo W, Zuker CS, Ryba NJ. T2Rs function as bitter taste receptors. Cell. 2000 Mar 17;100(6):703-11. doi: 10.1016/s0092-8674(00)80706-0.

    PMID: 10761935BACKGROUND

  • Margolskee RF, Dyer J, Kokrashvili Z, Salmon KS, Ilegems E, Daly K, Maillet EL, Ninomiya Y, Mosinger B, Shirazi-Beechey SP. T1R3 and gustducin in gut sense sugars to regulate expression of Na+-glucose cotransporter 1. Proc Natl Acad Sci U S A. 2007 Sep 18;104(38):15075-80. doi: 10.1073/pnas.0706678104. Epub 2007 Aug 27.

    PMID: 17724332BACKGROUND

  • Wu SV, Rozengurt N, Yang M, Young SH, Sinnett-Smith J, Rozengurt E. Expression of bitter taste receptors of the T2R family in the gastrointestinal tract and enteroendocrine STC-1 cells. Proc Natl Acad Sci U S A. 2002 Feb 19;99(4):2392-7. doi: 10.1073/pnas.042617699.

    PMID: 11854532BACKGROUND

  • Deshpande DA, Wang WC, McIlmoyle EL, Robinett KS, Schillinger RM, An SS, Sham JS, Liggett SB. Bitter taste receptors on airway smooth muscle bronchodilate by localized calcium signaling and reverse obstruction. Nat Med. 2010 Nov;16(11):1299-304. doi: 10.1038/nm.2237. Epub 2010 Oct 24.

    PMID: 20972434BACKGROUND

  • Kinnamon SC. Taste receptor signalling - from tongues to lungs. Acta Physiol (Oxf). 2012 Feb;204(2):158-68. doi: 10.1111/j.1748-1716.2011.02308.x. Epub 2011 May 7.

    PMID: 21481196BACKGROUND

  • Jang HJ, Kokrashvili Z, Theodorakis MJ, Carlson OD, Kim BJ, Zhou J, Kim HH, Xu X, Chan SL, Juhaszova M, Bernier M, Mosinger B, Margolskee RF, Egan JM. Gut-expressed gustducin and taste receptors regulate secretion of glucagon-like peptide-1. Proc Natl Acad Sci U S A. 2007 Sep 18;104(38):15069-74. doi: 10.1073/pnas.0706890104. Epub 2007 Aug 27.

    PMID: 17724330BACKGROUND

  • Steinert RE, Gerspach AC, Gutmann H, Asarian L, Drewe J, Beglinger C. The functional involvement of gut-expressed sweet taste receptors in glucose-stimulated secretion of glucagon-like peptide-1 (GLP-1) and peptide YY (PYY). Clin Nutr. 2011 Aug;30(4):524-32. doi: 10.1016/j.clnu.2011.01.007. Epub 2011 Feb 15.

    PMID: 21324568BACKGROUND

  • Jeon TI, Zhu B, Larson JL, Osborne TF. SREBP-2 regulates gut peptide secretion through intestinal bitter taste receptor signaling in mice. J Clin Invest. 2008 Nov;118(11):3693-700. doi: 10.1172/JCI36461. Epub 2008 Oct 9.

    PMID: 18846256BACKGROUND

  • Chandra R, Liddle RA. Cholecystokinin. Curr Opin Endocrinol Diabetes Obes. 2007 Feb;14(1):63-7. doi: 10.1097/MED.0b013e3280122850.

    PMID: 17940422BACKGROUND

  • Chao CY, Huang CJ. Bitter gourd (Momordica charantia) extract activates peroxisome proliferator-activated receptors and upregulates the expression of the acyl CoA oxidase gene in H4IIEC3 hepatoma cells. J Biomed Sci. 2003 Nov-Dec;10(6 Pt 2):782-91. doi: 10.1159/000073966.

    PMID: 14631118BACKGROUND

  • Kim KS, Egan JM, Jang HJ. Denatonium induces secretion of glucagon-like peptide-1 through activation of bitter taste receptor pathways. Diabetologia. 2014 Oct;57(10):2117-25. doi: 10.1007/s00125-014-3326-5. Epub 2014 Jul 13.

    PMID: 25016595BACKGROUND

  • Kyriazis GA, Smith KR, Tyrberg B, Hussain T, Pratley RE. Sweet taste receptors regulate basal insulin secretion and contribute to compensatory insulin hypersecretion during the development of diabetes in male mice. Endocrinology. 2014 Jun;155(6):2112-21. doi: 10.1210/en.2013-2015. Epub 2014 Apr 8.

    PMID: 24712876BACKGROUND

  • Kyriazis GA, Soundarapandian MM, Tyrberg B. Sweet taste receptor signaling in beta cells mediates fructose-induced potentiation of glucose-stimulated insulin secretion. Proc Natl Acad Sci U S A. 2012 Feb 21;109(8):E524-32. doi: 10.1073/pnas.1115183109. Epub 2012 Feb 6.

    PMID: 22315413BACKGROUND

  • Nakagawa Y, Nagasawa M, Yamada S, Hara A, Mogami H, Nikolaev VO, Lohse MJ, Shigemura N, Ninomiya Y, Kojima I. Sweet taste receptor expressed in pancreatic beta-cells activates the calcium and cyclic AMP signaling systems and stimulates insulin secretion. PLoS One. 2009;4(4):e5106. doi: 10.1371/journal.pone.0005106. Epub 2009 Apr 8.

    PMID: 19352508BACKGROUND

  • Drewnowski A, Gomez-Carneros C. Bitter taste, phytonutrients, and the consumer: a review. Am J Clin Nutr. 2000 Dec;72(6):1424-35. doi: 10.1093/ajcn/72.6.1424.

    PMID: 11101467BACKGROUND

  • Bachmanov AA, Beauchamp GK. Taste receptor genes. Annu Rev Nutr. 2007;27:389-414. doi: 10.1146/annurev.nutr.26.061505.111329.

    PMID: 17444812BACKGROUND

Related Links

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.

MeSH Terms

Conditions

Diabetes MellitusMetabolic Diseases

Condition Hierarchy (Ancestors)

Glucose Metabolism DisordersNutritional and Metabolic DiseasesEndocrine System Diseases

Study Officials

  • Richard Pratley, MD

    Study Principal Investigator

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
OTHER
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

July 13, 2016

First Posted

August 8, 2016

Study Start

July 21, 2016

Primary Completion

September 12, 2018

Study Completion

January 21, 2022

Last Updated

August 3, 2022

Record last verified: 2022-08

Data Sharing

IPD Sharing
Will not share

Locations

US(1)