RISE Pediatric Medication Study

Exclusion Criteria

• •1. Underlying disease likely to limit life span and/or increase risk of intervention or an underlying condition that is likely to limit ability to participate in outcomes assessment
• •2. An underlying disease that affects glucose metabolism other than type 2 diabetes mellitus
• •3. Taking medications that affect glucose metabolism, or has an underlying condition that is likely to require such medications
• •4. Treatment with insulin for \>1 week preceding screening
• •5. Active infections
• •6. Renal disease (serum creatinine \>1.2 mg/dl) or serum potassium abnormality (\<3.4 or \>5.5 mmol/l)
• •7. Anemia (hemoglobin \<11 g/dl in girls, \<12 g/dl in boys) or known coagulopathy
• •8. Cardiovascular disease, including uncontrolled hypertension defined as average systolic or diastolic blood pressure \> 99 percentile for age or \>135/90, despite adequately prescribed antihypertensive medications. Participants must be able to safely tolerate administration of intravenous fluids required during clamp studies.
• •9. History of conditions that may be precipitated or exacerbated by a study drug:
• •1. Serum alanine transaminase (ALT) more than 3 times the upper limit of normal
• •2. Excessive alcohol intake
• •3. Sub-optimally treated thyroid disease
• •10. Conditions or behaviors likely to affect the conduct of the RISE Study
• •1. Participant and/or parents unable or unwilling to give informed consent
• •2. Participant and/or parents unable to adequately communicate with clinic staff
• •3. Another household member is a participant or staff member in RISE
• •4. Current, recent or anticipated participation in another intervention research project that would interfere with any of the interventions/outcomes in RISE
• •5. Weight loss of ≥5% of body weight in the past 3 months for any reason other than post-partum weight loss. Participants taking weight loss drugs or using preparations taken for intended weight loss are excluded.
• •6. Likely to move away from participating clinics in next 2 years
• •7. Current (or anticipated) pregnancy and lactation.
• •8. A pregnancy that was completed less than 6 months prior to screening.
• •9. Breast feeding within 6 months prior to screening.
• •10. Women of childbearing potential who are unwilling to use adequate contraception
• •11. Major psychiatric disorder that, in the opinion of clinic staff, would impede the conduct of RISE
• •11. Additional conditions may serve as criteria for exclusion at the discretion of the local site.