A comparison of the baseline metabolic profiles between Diabetes Prevention Trial-Type 1 and TrialNet Natural History Study participants.
OBJECTIVE
We assessed whether differing autoantibody screening criteria for type 1 diabetes (T1D) prevention trials result in different baseline metabolic profiles of those who screen positive.


METHODS
Diabetes Prevention Trial-Type 1 (DPT-1) participants were screened for islet cell autoantibodies, whereas TrialNet Natural History Study (TNNHS) participants were screened for biochemical autoantibodies. In both studies, those determined to be autoantibody positive underwent baseline oral glucose tolerance tests (OGTTs) in which glucose and C-peptide were measured.


RESULTS
The percentage of those with an OGTT in the diabetic range was higher among the DPT-1 participants (10.0% of 956 vs. 6.4% of 645, p < 0.01). In a logistic regression analysis with adjustments for age and gender, the difference persisted (p < 0.01). Among those in the non-diabetic range (n = 860 for DPT-1 and n = 604 for the TNNHS), glucose levels were similar at all time points, except for higher fasting glucose levels in the TNNHS participants (p < 0.001). There was a higher percentage of impaired fasting glucose (IFG) in the TNNHS participants (10.9 vs. 6.7%, p < 0.01); however, with adjustments for age and gender, there was no longer a significant difference. There was no significant difference in the percentages with impaired glucose tolerance. C-peptide levels were much lower in the DPT-1 cohort at all OGTT time points (p < 0.001 for all).


CONCLUSIONS
Differing criteria for autoantibody screening can result in marked differences in the baseline metabolic profiles of prospective participants of T1D prevention trials.
Sosenko
Jay M
JM
Division of Endocrinology, University of Miami, Miami, FL, USA. jsosenko@med.miami.edu
Mahon
Jeffrey
J
Rafkin
Lisa
L
Lachin
John M
JM
Krause-Steinrauf
Heidi
H
Krischer
Jeffrey P
JP
Cuthbertson
David
D
Palmer
Jerry P
JP
Thompson
Clinton
C
Greenbaum
Carla J
CJ
Skyler
Jay S
JS
D000293:Adolescent; D000328:Adult; D001323:Autoantibodies / Q000032:analysis* / Q000378:metabolism; D001481:Basal Metabolism / Q000502:physiology*; D015415:Biomarkers / Q000032:analysis / Q000378:metabolism; D002648:Child; D002675:Child, Preschool; D002986:Clinical Trials as Topic / Q000379:methods*; D015331:Cohort Studies; D003922:Diabetes Mellitus, Type 1 / Q000175:diagnosis / Q000378:metabolism / Q000517:prevention & control*; D005260:Female; D006801:Humans; D007223:Infant; D008297:Male; D008403:Mass Screening / Q000379:methods; D055442:Metabolome; D008875:Middle Aged; D055815:Young Adult
D001323:Autoantibodies; D015415:Biomarkers; C024211:islet cell antibody