Restoring Insulin Secretion (RISE): design of studies of beta-cell preservation in prediabetes and early type 2 diabetes across the life span

OBJECTIVE: The Restoring Insulin Secretion (RISE) Consortium is testing interventions designed to preserve or improve beta-cell function in prediabetes or early type 2 diabetes. RESEARCH DESIGN AND METHODS: beta-Cell function is measured using hyperglycemic clamps and oral glucose tolerance tests (OGTTs). The adult medication protocol randomizes participants to 12 months of placebo, metformin alone, liraglutide plus metformin, or insulin (3 months) followed by metformin (9 months). The pediatric medication protocol randomizes participants to metformin or insulin followed by metformin. The adult surgical protocol randomizes participants to gastric banding or metformin (24 months). Adult medication protocol inclusion criteria include fasting plasma glucose 95-125 mg/dL (5.3-6.9 mmol/L), OGTT 2-h glucose >/=140 mg/dL (>/=7.8 mmol/L), HbA1c 5.8-7.0% (40-53 mmol/mol), and BMI 25-40 kg/m(2). Adult surgical protocol criteria are similar, except for fasting plasma glucose >/=90 mg/dL (>/=5.0 mmol/L), BMI 30-40 kg/m(2), HbA1c /=90 mg/dL (>/=5.0 mmol/L), 2-h glucose >/=140 mg/dL (>/=7.8 mmol/L), HbA1c /=90 mg/dL (>/=5.0 mmol/L), 2-h glucose >/=140 mg/dL (>/=7.8 mmol/L), HbA1c 85th percentile and