Table 2 Study treatment visit schedule

From: A randomized trial of oral gamma aminobutyric acid (GABA) or the combination of GABA with glutamic acid decarboxylase (GAD) on pancreatic islet endocrine function in children with newly diagnosed type 1 diabetes

  

Study visit

Study group

Treatments

Baseline Visit #1

Month 1 Visit #2

Month 5 Visit #3

Month 8 Visit #4

Month 12 Visit #5

GABA

GABA

oral twice daily

Placebo-GAD

one injection:

visits #1 and #2

MMTTa

MMTT

MMTT

HbA1c

Insulin- dose

MMTT

GABA/GADb

GABA

oral twice daily

GAD

one injection:

visits #1 and #2

MMTT

MMTT

MMTT

HbA1c

Insulin- dose

MMTT

Placebo

Placebo-GABA

oral twice daily

Placebo-GAD

one injection:

visits #1 and #2

MMTT

MMTT

MMTT

HbA1c

Insulin- dose

MMTT

  1. aMMTT- Mixed meal tolerance test. bGAD = GAD-alum (Diamyd, Stockholm, Sweden) was administered on visit #1 and the second dose was administered on visit #2.GABA (gamma aminobutyric acid), insulin-dose (total daily insulin dose).
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