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Withdrawal of medications leads to worsening of OGTT parameters in youth with impaired glucose tolerance or recently‐diagnosed type 2 diabetes
Author(s) -
Han Tamara S.,
Edelstein Sharon L.,
Arslanian Silva A.,
Caprio Sonia,
Zeitler Philip S.,
Buchanan Thomas A.,
Ehrmann David A.,
Mather Kieren J.,
Tripputi Mark,
Kahn Steven E.,
Nadeau Kristen J.
Publication year - 2020
Publication title -
pediatric diabetes
Language(s) - English
Resource type - Journals
SCImago Journal Rank - 1.678
H-Index - 75
eISSN - 1399-5448
pISSN - 1399-543X
DOI - 10.1111/pedi.13129
Subject(s) - medicine , impaired glucose tolerance , type 2 diabetes , diabetes mellitus , endocrinology
Background The RISE Pediatric Medication Study compared strategies for preserving β‐cell function, including a 9‐month follow‐up after treatment withdrawal to test treatment effect durability. Objective Evaluate OGTT measures of glucose and β‐cell response through 12 months of intervention and 9 months of medication washout. Participants Youth (n = 91) aged 10 to 19 years with BMI ≥85th percentile and impaired glucose tolerance (IGT) or recently diagnosed type 2 diabetes (T2D). Methods A multicenter randomized clinical trial comparing insulin glargine for 3 months followed by metformin for 9 months (G→Met) or metformin alone (Met) for 12 months. We report within‐group changes from baseline to end of medication intervention (M12), baseline to 9 months post‐medication withdrawal (M21), and end of medication (M12) to M21. OGTT C‐peptide index [CPI] paired with 1/fasting insulin evaluated β‐cell response. Results At M12, both treatments were associated with stable fasting glucose (G→Met baseline 6.0 ± 0.1 vs M12 5.9 ± 0.2 mmol/L, P = .62; Met baseline 6.1 ± 0.2 vs M12 6.0 ± 0.2 mmol/L, P = .73) and 2‐hour glucose (G→Met baseline 10.2 ± 0.4 vs M12 9.3 ± 0.5 mmol/L, P = .03; Met baseline 10.2 ± 0.4 vs M12 10.6 ± 0.6 mmol/L, P = .88). Following medication withdrawal, fasting glucose worsened (G→Met M21 8.6 ± 1.8, P = .004; Met M21 7.8 ± 0.7 mmol/L, P = .003), as did 2‐hour glucose (G→Met M21 13.2 ± 1.4, P = .002; Met M21 13.1 ± 1.2 mmol/L, P = .006), associated with declines in β‐cell response. Conclusions G→Met and Met were associated with stable glucose measures during 12 months of treatment in youth with IGT or recently diagnosed T2D. Glucose and β‐cell response worsened post‐medication withdrawal, suggesting treatment must be long‐term or alternative treatments pursued.