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Diabetes Obes Metab. 2018 Jan;20(1):14-24. doi: 10.1111/dom.13005. Epub 2017 Jun 22.

Review of methods for measuring β-cell function: Design considerations from the Restoring Insulin Secretion (RISE) Consortium.

Author information

1
Departments of Pediatrics (T. S. H.) and Medicine (K. J. M.), Indiana University School of Medicine, Indianapolis, Indiana.
2
VA Puget Sound Health Care System and Department of Medicine, University of Washington, Seattle, Washington.
3
University of Southern California Keck School of Medicine/Kaiser Permanente Southern California, Department of Medicine, Los Angeles, California.
4
University of Colorado Denver/Children's Hospital Colorado, Department of Pediatrics, Denver, Colorado.
5
University of Chicago, Chicago, Illinois.
6
Children's Hospital of Pittsburgh, University of Pittsburgh Medical Center, Department of Pediatrics, Pittsburgh, Pennsylvania.
7
Department of Pediatrics, Yale University, New Haven, Connecticut.
8
George Washington University Biostatistics Center (RISE Coordinating Center), Rockville, Maryland.
9
National Institute of Diabetes, Digestive and Kidney Diseases, Bethesda, Maryland.

Abstract

The Restoring Insulin Secretion (RISE) study was initiated to evaluate interventions to slow or reverse the progression of β-cell failure in type 2 diabetes (T2D). To design the RISE study, we undertook an evaluation of methods for measurement of β-cell function and changes in β-cell function in response to interventions. In the present paper, we review approaches for measurement of β-cell function, focusing on methodologic and feasibility considerations. Methodologic considerations included: (1) the utility of each technique for evaluating key aspects of β-cell function (first- and second-phase insulin secretion, maximum insulin secretion, glucose sensitivity, incretin effects) and (2) tactics for incorporating a measurement of insulin sensitivity in order to adjust insulin secretion measures for insulin sensitivity appropriately. Of particular concern were the capacity to measure β-cell function accurately in those with poor function, as is seen in established T2D, and the capacity of each method for demonstrating treatment-induced changes in β-cell function. Feasibility considerations included: staff burden, including time and required methodological expertise; participant burden, including time and number of study visits; and ease of standardizing methods across a multicentre consortium. After this evaluation, we selected a 2-day measurement procedure, combining a 3-hour 75-g oral glucose tolerance test and a 2-stage hyperglycaemic clamp procedure, augmented with arginine.

TRIAL REGISTRATION:

ClinicalTrials.gov NCT01779362 NCT01779375 NCT01763346.

KEYWORDS:

glucose metabolism; insulin resistance; insulin secretion; type 2 diabetes; β cell

PMID:
28493515
PMCID:
PMC6095472
DOI:
10.1111/dom.13005
[Indexed for MEDLINE]
Free PMC Article

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