TABLE 3.
Assessment/Procedure | 0 mo Enrollment | +3 mo (Metabolic Visit) | +6 mo | +12 mo | 18 mo | 24–60 mo (Annual) | New Diagnosis of DM |
---|---|---|---|---|---|---|---|
Research visit (Time window) | X (0–90 d after AP) | X (−2 to +6 wk) | X or * (−6 wk to +3 mo) | X (−3 to +3 mo) | X or (−3 to +3 mo) | X (±6 mo) | |
General | |||||||
Demographics and medical history | X | ||||||
Interim medical history | X | X | X | X | X | X | |
Height, weight, waist circumference | X | X | X | X | X | ||
Questionnaires | |||||||
Quality of life, EPI GI Symptom tracker | X | X | X | X | |||
Food frequency questionnaire | X | X | X | ||||
Labs | |||||||
FBG, HbA1c, autoantibodies | X | X | X | X | X | X | |
CBC with diff, creatinine, FE-1 | X | X | X | X | |||
Metabolic testing | |||||||
OGTT | X | ||||||
Serial OGTT arm | X | X | X (MMTT) | ||||
Serial MMTT arm† | X† | X | X | X | |||
Serial FSIGTT arm† | X† | X | X (MMTT) | ||||
Imaging | |||||||
Research MRI/MRCP‡ | X | X | X3 | X | |||
Biorepository | |||||||
Blood§ | X | X | X | X | X | ||
Stool|| | X | X | X |
The reference time point zero represents the date a participant first met the diagnostic criteria for their qualifying AP.
symbol indicates this visit could be conducted by telephone;
Serial MMTT and FSIGTT will be performed in a subset of participants. These tests will be offered to participants without DM at 3-mo visit;
Research MRI/MRCP will be performed in a subset of participants through 36 mo;
Blood will be collected for serum, plasma, peripheral blood mononuclear cells, blood cell stabilizers (whole blood added to SmartTube Proteomic Stabilizer), Tempus tubes (RNAseq), and DNA (from a single blood collection);
Stool samples will be collected using methods that will allow microbiome and metabolic analyses.
diff indicates differential; EPI, exocrine pancreatic insufficiency; FBG, fasting blood glucose; FE-1, fecal elastase-1; GI, gastrointestinal; OGTT, oral glucose tolerance test; MMTT, mixed meal tolerance test; FSIGTT, frequently sampled intravenous glucose tolerance test.