A static glucose-stimulated insulin secretion (sGSIS) assay that is significantly predictive of time to diabetes reversal in the human islet bioassay

Introduction Static incubation (static glucose-stimulated insulin secretion, sGSIS) is a measure of islet secretory function. The Stimulation Index (SI; insulin produced in high glucose/insulin produced in low glucose) is currently used as a product release criterion of islet transplant potency.Rese...

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Main Authors: Ruth Damaris Molano, Antonello Pileggi, Hubert M Tse, Cherie L Stabler, Christopher A Fraker
Format: Article
Language:English
Published: BMJ Publishing Group 2024-04-01
Series:BMJ Open Diabetes Research & Care
Online Access:https://drc.bmj.com/content/12/2/e003897.full
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author Ruth Damaris Molano
Antonello Pileggi
Hubert M Tse
Cherie L Stabler
Christopher A Fraker
author_facet Ruth Damaris Molano
Antonello Pileggi
Hubert M Tse
Cherie L Stabler
Christopher A Fraker
author_sort Ruth Damaris Molano
collection DOAJ
description Introduction Static incubation (static glucose-stimulated insulin secretion, sGSIS) is a measure of islet secretory function. The Stimulation Index (SI; insulin produced in high glucose/insulin produced in low glucose) is currently used as a product release criterion of islet transplant potency.Research design and methods Our hypothesis was that the Delta, insulin secreted in high glucose minus insulin secreted in low glucose, would be more predictive. To evaluate this hypothesis, sGSIS was performed on 32 consecutive human islet preparations, immobilizing the islets in a slurry of Sepharose beads to minimize mechanical perturbation. Simultaneous full-mass subrenal capsular transplants were performed in chemically induced diabetic immunodeficient mice. Logistic regression analysis was used to determine optimal cut-points for diabetes reversal time and the Fisher Exact Test was used to assess the ability of the Delta and the SI to accurately classify transplant outcomes. Receiver operating characteristic curve analysis was performed on cut-point grouped data, assessing the predictive power and optimal cut-point for each sGSIS potency metric. Finally, standard Kaplan-Meier-type survival analysis was conducted.Results In the case of the sGSIS the Delta provided a superior islet potency metric relative to the SI.ConclusionsThe sGSIS Delta value is predicitive of time to diabetes reversal in the full mass human islet transplant bioassay.
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spelling doaj-art-a2883b83a3bc46e59f5f9b2e828927f02024-12-29T16:50:12ZengBMJ Publishing GroupBMJ Open Diabetes Research & Care2052-48972024-04-0112210.1136/bmjdrc-2023-003897A static glucose-stimulated insulin secretion (sGSIS) assay that is significantly predictive of time to diabetes reversal in the human islet bioassayRuth Damaris Molano0Antonello Pileggi1Hubert M Tse2Cherie L Stabler3Christopher A Fraker4Cell Transplant Center, Diabetes Research Institute, University of Miami, Coral Gables, Florida, USACell Transplant Center, Diabetes Research Institute, University of Miami, Coral Gables, Florida, USAMicrobiology, Molecular Genetics, and Immunology, University of Kansas Medical Center, Kansas City, Kansas, USADepartment of Biomedical Engineering, University of Miami, Coral Gables, Florida, USADiabetes Research Institute, University of Miami Miller School of Medicine, Miami, Florida, USAIntroduction Static incubation (static glucose-stimulated insulin secretion, sGSIS) is a measure of islet secretory function. The Stimulation Index (SI; insulin produced in high glucose/insulin produced in low glucose) is currently used as a product release criterion of islet transplant potency.Research design and methods Our hypothesis was that the Delta, insulin secreted in high glucose minus insulin secreted in low glucose, would be more predictive. To evaluate this hypothesis, sGSIS was performed on 32 consecutive human islet preparations, immobilizing the islets in a slurry of Sepharose beads to minimize mechanical perturbation. Simultaneous full-mass subrenal capsular transplants were performed in chemically induced diabetic immunodeficient mice. Logistic regression analysis was used to determine optimal cut-points for diabetes reversal time and the Fisher Exact Test was used to assess the ability of the Delta and the SI to accurately classify transplant outcomes. Receiver operating characteristic curve analysis was performed on cut-point grouped data, assessing the predictive power and optimal cut-point for each sGSIS potency metric. Finally, standard Kaplan-Meier-type survival analysis was conducted.Results In the case of the sGSIS the Delta provided a superior islet potency metric relative to the SI.ConclusionsThe sGSIS Delta value is predicitive of time to diabetes reversal in the full mass human islet transplant bioassay.https://drc.bmj.com/content/12/2/e003897.full
spellingShingle Ruth Damaris Molano
Antonello Pileggi
Hubert M Tse
Cherie L Stabler
Christopher A Fraker
A static glucose-stimulated insulin secretion (sGSIS) assay that is significantly predictive of time to diabetes reversal in the human islet bioassay
BMJ Open Diabetes Research & Care
title A static glucose-stimulated insulin secretion (sGSIS) assay that is significantly predictive of time to diabetes reversal in the human islet bioassay
title_full A static glucose-stimulated insulin secretion (sGSIS) assay that is significantly predictive of time to diabetes reversal in the human islet bioassay
title_fullStr A static glucose-stimulated insulin secretion (sGSIS) assay that is significantly predictive of time to diabetes reversal in the human islet bioassay
title_full_unstemmed A static glucose-stimulated insulin secretion (sGSIS) assay that is significantly predictive of time to diabetes reversal in the human islet bioassay
title_short A static glucose-stimulated insulin secretion (sGSIS) assay that is significantly predictive of time to diabetes reversal in the human islet bioassay
title_sort static glucose stimulated insulin secretion sgsis assay that is significantly predictive of time to diabetes reversal in the human islet bioassay
url https://drc.bmj.com/content/12/2/e003897.full
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