PMID- 18628574
OWN - NLM
STAT- MEDLINE
DCOM- 20081118
LR  - 20220331
IS  - 1935-5548 (Electronic)
IS  - 0149-5992 (Print)
IS  - 0149-5992 (Linking)
VI  - 31
IP  - 10
DP  - 2008 Oct
TI  - Mixed-meal tolerance test versus glucagon stimulation test for the assessment of 
      beta-cell function in therapeutic trials in type 1 diabetes.
PG  - 1966-71
LID - 10.2337/dc07-2451 [doi]
AB  - OBJECTIVE: Beta-cell function in type 1 diabetes clinical trials is commonly 
      measured by C-peptide response to a secretagogue in either a mixed-meal tolerance 
      test (MMTT) or a glucagon stimulation test (GST). The Type 1 Diabetes TrialNet 
      Research Group and the European C-peptide Trial (ECPT) Study Group conducted 
      parallel randomized studies to compare the sensitivity, reproducibility, and 
      tolerability of these procedures. RESEARCH DESIGN AND METHODS: In randomized 
      sequences, 148 TrialNet subjects completed 549 tests with up to 2 MMTT and 2 GST 
      tests on separate days, and 118 ECPT subjects completed 348 tests (up to 3 each) 
      with either two MMTTs or two GSTs. RESULTS: Among individuals with up to 4 years' 
      duration of type 1 diabetes, >85% had measurable stimulated C-peptide values. The 
      MMTT stimulus produced significantly higher concentrations of C-peptide than the 
      GST. Whereas both tests were highly reproducible, the MMTT was significantly more 
      so (R(2) = 0.96 for peak C-peptide response). Overall, the majority of subjects 
      preferred the MMTT, and there were few adverse events. Some older subjects 
      preferred the shorter duration of the GST. Nausea was reported in the majority of 
      GST studies, particularly in the young age-group. CONCLUSIONS: The MMTT is 
      preferred for the assessment of beta-cell function in therapeutic trials in type 
      1 diabetes.
FAU - Greenbaum, Carla J
AU  - Greenbaum CJ
AD  - TrialNet Publications, The Biostatistics Center, Rockville, Maryland, USA. 
      cjgreen@benaroyaresearch.org
FAU - Mandrup-Poulsen, Thomas
AU  - Mandrup-Poulsen T
FAU - McGee, Paula Friedenberg
AU  - McGee PF
FAU - Battelino, Tadej
AU  - Battelino T
FAU - Haastert, Burkhard
AU  - Haastert B
FAU - Ludvigsson, Johnny
AU  - Ludvigsson J
FAU - Pozzilli, Paolo
AU  - Pozzilli P
FAU - Lachin, John M
AU  - Lachin JM
FAU - Kolb, Hubert
AU  - Kolb H
CN  - Type 1 Diabetes Trial Net Research Group
CN  - European C-Peptide Trial Study Group
LA  - eng
SI  - ClinicalTrials.gov/NCT00105352
GR  - U01 DK061034/DK/NIDDK NIH HHS/United States
PT  - Journal Article
PT  - Multicenter Study
PT  - Research Support, N.I.H., Extramural
PT  - Research Support, Non-U.S. Gov't
DEP - 20080715
PL  - United States
TA  - Diabetes Care
JT  - Diabetes care
JID - 7805975
RN  - 0 (Biomarkers)
RN  - 0 (C-Peptide)
RN  - 9007-92-5 (Glucagon)
SB  - IM
MH  - Adolescent
MH  - Adult
MH  - Age of Onset
MH  - Biomarkers/blood
MH  - C-Peptide/*blood
MH  - Child
MH  - Clinical Trials as Topic
MH  - Diabetes Mellitus, Type 1/*diet therapy/physiopathology
MH  - *Diet, Diabetic
MH  - Fasting
MH  - *Glucagon/pharmacology
MH  - Humans
MH  - Insulin-Secreting Cells/drug effects/*physiology
MH  - Racial Groups
MH  - Random Allocation
MH  - Sensitivity and Specificity
PMC - PMC2551636
FIR - Greenbaum, Carla J
IR  - Greenbaum CJ
FIR - McGee, Paula F
IR  - McGee PF
FIR - Lachin, John M
IR  - Lachin JM
FIR - Mandrup-Poulsen, Thomas
IR  - Mandrup-Poulsen T
FIR - Battelino, Tadej
IR  - Battelino T
FIR - Haastert, Burkhard
IR  - Haastert B
FIR - Ludvigsson, Johnny
IR  - Ludvigsson J
FIR - Pozzilli, Paolo
IR  - Pozzilli P
FIR - Kolb, Hubert
IR  - Kolb H
EDAT- 2008/07/17 09:00
MHDA- 2008/11/19 09:00
PMCR- 2009/10/01
CRDT- 2008/07/17 09:00
PHST- 2008/07/17 09:00 [pubmed]
PHST- 2008/11/19 09:00 [medline]
PHST- 2008/07/17 09:00 [entrez]
PHST- 2009/10/01 00:00 [pmc-release]
AID - dc07-2451 [pii]
AID - 31101966 [pii]
AID - 10.2337/dc07-2451 [doi]
PST - ppublish
SO  - Diabetes Care. 2008 Oct;31(10):1966-71. doi: 10.2337/dc07-2451. Epub 2008 Jul 15.