PMID- 30023442
OWN - NLM
STAT- PubMed-not-MEDLINE
LR  - 20220318
IS  - 2451-8654 (Electronic)
IS  - 2451-8654 (Linking)
VI  - 10
DP  - 2018 Jun
TI  - Outpatient versus inpatient mixed meal tolerance and arginine stimulation testing 
      yields comparable measures of variability for assessment of beta cell function.
PG  - 94-99
LID - 10.1016/j.conctc.2018.03.009 [doi]
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 (Phitot); and disposition index 
      (DItot = Si* Phitot) 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: 
      see text] 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.
FAU - Shankar, Sudha S
AU  - Shankar SS
AD  - Eli Lilly and Company, United States.
FAU - Lee, Douglas S
AU  - Lee DS
AD  - Pfizer, United States.
FAU - Raymond, Ralph H
AU  - Raymond RH
AD  - R-Squared Solutions, United States.
FAU - Calle, Roberto A
AU  - Calle RA
AD  - Pfizer, United States.
FAU - Cobelli, Claudio
AU  - Cobelli C
AD  - University of Padova, Italy.
FAU - Ghosh, Atalanta
AU  - Ghosh A
AD  - Janssen, Belgium.
FAU - Robertson, R Paul
AU  - Robertson RP
AD  - PNRI, Univ. Washington, United States.
FAU - Ruetten, Hartmut
AU  - Ruetten H
AD  - Sanofi, France.
FAU - Staten, Myrlene A
AU  - Staten MA
AD  - (c) Kelly Government Solutions for NIDDK, United States.
FAU - Stefanovski, Darko
AU  - Stefanovski D
AD  - University of Pennsylvania, United States.
FAU - Vella, Adrian
AU  - Vella A
AD  - Mayo Clinic, United States.
FAU - Whitaker, Sanya
AU  - Whitaker S
AD  - Foundation for the NIH, United States.
FAU - Fryburg, David A
AU  - Fryburg DA
AD  - ROI BioPharma Consulting, United States.
CN  - Foundation for the NIH Biomarkers Consortium Beta Cell Project Team
LA  - eng
PT  - Journal Article
DEP - 20180329
PL  - Netherlands
TA  - Contemp Clin Trials Commun
JT  - Contemporary clinical trials communications
JID - 101671157
PMC - PMC6047312
EDAT- 2018/07/20 06:00
MHDA- 2018/07/20 06:01
PMCR- 2018/03/29
CRDT- 2018/07/20 06:00
PHST- 2017/12/06 00:00 [received]
PHST- 2018/03/19 00:00 [revised]
PHST- 2018/03/26 00:00 [accepted]
PHST- 2018/07/20 06:00 [entrez]
PHST- 2018/07/20 06:00 [pubmed]
PHST- 2018/07/20 06:01 [medline]
PHST- 2018/03/29 00:00 [pmc-release]
AID - S2451-8654(17)30196-5 [pii]
AID - 10.1016/j.conctc.2018.03.009 [doi]
PST - epublish
SO  - Contemp Clin Trials Commun. 2018 Mar 29;10:94-99. doi: 
      10.1016/j.conctc.2018.03.009. eCollection 2018 Jun.