Outpatient versus inpatient mixed meal tolerance and arginine stimulation testing yields comparable measures of variability for assessment of beta cell function

Foundation for the NIH Biomarkers Consortium Beta Cell Project Team

Research output: Contribution to journalArticle

Abstract

Standard practice to minimize variability in beta cell function (BCF) measurement is to test in inpatient (IP) settings. IP testing strains trial subjects, investigators, and budgets. Outpatient (OP) testing may be a solution although there are few reports on OP BCF testing variability. We compared variability metrics between OP and IP from a standardized mixed meal tolerance test (MMTT) and arginine stimulation test (AST) in two separate type 2 diabetes (T2DM) cohorts (OP, n = 20; IP n = 22) in test-retest design. MMTT variables included: insulin sensitivity (Si); beta cell responsivity (Φtot); and disposition index (DItot = Si* Φtot) following 470 kCal meal. AST variables included: acute insulin response to arginine (AIRarg) and during hyperglycemia (AIRargMAX). Results: Baseline characteristics were well-matched. Between and within subject variance for each parameter across cohorts, and intraclass correlation coefficients (ICC-a measure of reproducibility) across parameters were generally comparable for OP to IP. Table summarizes the ICC results for each key parameter and cohort. [Table presented] In conclusion, the variability (reproducibility) of BCF measures from standardized MMTT and AST is comparable between OP and IP settings. These observations have significant implications for complexity and cost of metabolic studies.

Original languageEnglish (US)
Pages (from-to)94-99
Number of pages6
JournalContemporary Clinical Trials Communications
Volume10
DOIs
StatePublished - Jun 1 2018

Fingerprint

Meals
Arginine
Inpatients
Outpatients
Budgets
Hyperglycemia
Type 2 Diabetes Mellitus
Insulin Resistance
Research Personnel
Insulin
Costs and Cost Analysis

ASJC Scopus subject areas

  • Pharmacology

Cite this

Outpatient versus inpatient mixed meal tolerance and arginine stimulation testing yields comparable measures of variability for assessment of beta cell function. / Foundation for the NIH Biomarkers Consortium Beta Cell Project Team.

In: Contemporary Clinical Trials Communications, Vol. 10, 01.06.2018, p. 94-99.

Research output: Contribution to journalArticle

@article{2d4c53b330b149f28545e2901637b508,
title = "Outpatient versus inpatient mixed meal tolerance and arginine stimulation testing yields comparable measures of variability for assessment of beta cell function",
abstract = "Standard practice to minimize variability in beta cell function (BCF) measurement is to test in inpatient (IP) settings. IP testing strains trial subjects, investigators, and budgets. Outpatient (OP) testing may be a solution although there are few reports on OP BCF testing variability. We compared variability metrics between OP and IP from a standardized mixed meal tolerance test (MMTT) and arginine stimulation test (AST) in two separate type 2 diabetes (T2DM) cohorts (OP, n = 20; IP n = 22) in test-retest design. MMTT variables included: insulin sensitivity (Si); beta cell responsivity (Φtot); and disposition index (DItot = Si* Φtot) following 470 kCal meal. AST variables included: acute insulin response to arginine (AIRarg) and during hyperglycemia (AIRargMAX). Results: Baseline characteristics were well-matched. Between and within subject variance for each parameter across cohorts, and intraclass correlation coefficients (ICC-a measure of reproducibility) across parameters were generally comparable for OP to IP. Table summarizes the ICC results for each key parameter and cohort. [Table presented] In conclusion, the variability (reproducibility) of BCF measures from standardized MMTT and AST is comparable between OP and IP settings. These observations have significant implications for complexity and cost of metabolic studies.",
author = "{Foundation for the NIH Biomarkers Consortium Beta Cell Project Team} and Shankar, {Sudha S.} and Lee, {Douglas S.} and Raymond, {Ralph H.} and Calle, {Roberto A.} and Claudio Cobelli and Atalanta Ghosh and Robertson, {R. Paul} and Hartmut Ruetten and Staten, {Myrlene A.} and Darko Stefanovski and Adrian Vella and Sanya Whitaker and Fryburg, {David A.}",
year = "2018",
month = "6",
day = "1",
doi = "10.1016/j.conctc.2018.03.009",
language = "English (US)",
volume = "10",
pages = "94--99",
journal = "Contemporary Clinical Trials Communications",
issn = "2451-8654",
publisher = "Elsevier Inc.",

}

TY - JOUR

T1 - Outpatient versus inpatient mixed meal tolerance and arginine stimulation testing yields comparable measures of variability for assessment of beta cell function

AU - Foundation for the NIH Biomarkers Consortium Beta Cell Project Team

AU - Shankar, Sudha S.

AU - Lee, Douglas S.

AU - Raymond, Ralph H.

AU - Calle, Roberto A.

AU - Cobelli, Claudio

AU - Ghosh, Atalanta

AU - Robertson, R. Paul

AU - Ruetten, Hartmut

AU - Staten, Myrlene A.

AU - Stefanovski, Darko

AU - Vella, Adrian

AU - Whitaker, Sanya

AU - Fryburg, David A.

PY - 2018/6/1

Y1 - 2018/6/1

N2 - Standard practice to minimize variability in beta cell function (BCF) measurement is to test in inpatient (IP) settings. IP testing strains trial subjects, investigators, and budgets. Outpatient (OP) testing may be a solution although there are few reports on OP BCF testing variability. We compared variability metrics between OP and IP from a standardized mixed meal tolerance test (MMTT) and arginine stimulation test (AST) in two separate type 2 diabetes (T2DM) cohorts (OP, n = 20; IP n = 22) in test-retest design. MMTT variables included: insulin sensitivity (Si); beta cell responsivity (Φtot); and disposition index (DItot = Si* Φtot) following 470 kCal meal. AST variables included: acute insulin response to arginine (AIRarg) and during hyperglycemia (AIRargMAX). Results: Baseline characteristics were well-matched. Between and within subject variance for each parameter across cohorts, and intraclass correlation coefficients (ICC-a measure of reproducibility) across parameters were generally comparable for OP to IP. Table summarizes the ICC results for each key parameter and cohort. [Table presented] In conclusion, the variability (reproducibility) of BCF measures from standardized MMTT and AST is comparable between OP and IP settings. These observations have significant implications for complexity and cost of metabolic studies.

AB - Standard practice to minimize variability in beta cell function (BCF) measurement is to test in inpatient (IP) settings. IP testing strains trial subjects, investigators, and budgets. Outpatient (OP) testing may be a solution although there are few reports on OP BCF testing variability. We compared variability metrics between OP and IP from a standardized mixed meal tolerance test (MMTT) and arginine stimulation test (AST) in two separate type 2 diabetes (T2DM) cohorts (OP, n = 20; IP n = 22) in test-retest design. MMTT variables included: insulin sensitivity (Si); beta cell responsivity (Φtot); and disposition index (DItot = Si* Φtot) following 470 kCal meal. AST variables included: acute insulin response to arginine (AIRarg) and during hyperglycemia (AIRargMAX). Results: Baseline characteristics were well-matched. Between and within subject variance for each parameter across cohorts, and intraclass correlation coefficients (ICC-a measure of reproducibility) across parameters were generally comparable for OP to IP. Table summarizes the ICC results for each key parameter and cohort. [Table presented] In conclusion, the variability (reproducibility) of BCF measures from standardized MMTT and AST is comparable between OP and IP settings. These observations have significant implications for complexity and cost of metabolic studies.

UR - http://www.scopus.com/inward/record.url?scp=85045074640&partnerID=8YFLogxK

UR - http://www.scopus.com/inward/citedby.url?scp=85045074640&partnerID=8YFLogxK

U2 - 10.1016/j.conctc.2018.03.009

DO - 10.1016/j.conctc.2018.03.009

M3 - Article

AN - SCOPUS:85045074640

VL - 10

SP - 94

EP - 99

JO - Contemporary Clinical Trials Communications

JF - Contemporary Clinical Trials Communications

SN - 2451-8654

ER -