RISE Pediatric Medication Study

Completed · Phase 3

Conditions studied: Prediabetes, Type 2 Diabetes

In brief

The RISE Pediatric Medication Study is a 2-arm, 4-center, clinical trial of children with prediabetes and early type 2 diabetes to address the hypothesis that aggressive glucose lowering will lead to recovery of beta-cell function that will be sustained after withdrawal of treatment. Pediatric participants (ages 10-19) will be randomized to one of the following treatment regimens: (1) metformin alone or (2) early intensive treatment with basal insulin glargine followed by metformin. The primary clinical question RISE will address is: Are improvements in ß-cell function following 12 months of active treatment maintained for 3 months following the withdrawal of therapy? Secondary outcomes will assess durability of glucose tolerance following withdrawal of therapy, and whether biomarkers obtained in the fasting state predict parameters of ß-cell function, insulin sensitivity and glucose tolerance and the response to an intervention.

Key facts

Study ID

NCT01779375

Run by

RISE Study Group

People needed

91

Starts

2013-06-16

Expected to finish

2018-04-01

Last updated by the study team

2023-04-14

Who can join

Age: 10 and older, up to 19. Sex: any. Healthy volunteers: accepted.

You may qualify if…

• Fasting plasma glucose ≥90 mg/dl plus 2-hour glucose ≥140 mg/dl on 75 gm OGTT plus laboratory-based HbA1c ≤8.0% if treatment naïve. There is no upper limit for the 2-hour glucose on OGTT. In those taking metformin laboratory-based HbA1c must be ≤7.5% if on metformin for <3 months and ≤7.0% if on metformin for 3-6 months.
• Age 10-19 years
• Pubertal development Tanner stage >1 as defined by breast stage >1 in girls, and testes >3 cc's in boys.
• Body mass index (BMI) ≥85th percentile but ≤50 kg/m2
• Self-reported diabetes <6 months in duration
• Treatment with metformin for <6 months preceding screening

You may not qualify if…

• 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
• An underlying disease that affects glucose metabolism other than type 2 diabetes mellitus
• Taking medications that affect glucose metabolism, or has an underlying condition that is likely to require such medications
• Treatment with insulin for >1 week preceding screening
• Active infections
• Renal disease (serum creatinine >1.2 mg/dl) or serum potassium abnormality (<3.4 or >5.5 mmol/l)
• Anemia (hemoglobin <11 g/dl in girls, <12 g/dl in boys) or known coagulopathy
• 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.
• History of conditions that may be precipitated or exacerbated by a study drug:
• Serum alanine transaminase (ALT) more than 3 times the upper limit of normal
• Excessive alcohol intake
• Sub-optimally treated thyroid disease
• Conditions or behaviors likely to affect the conduct of the RISE Study
• Participant and/or parents unable or unwilling to give informed consent
• Participant and/or parents unable to adequately communicate with clinic staff
• Another household member is a participant or staff member in RISE
• Current, recent or anticipated participation in another intervention research project that would interfere with any of the interventions/outcomes in RISE
• 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.
• Likely to move away from participating clinics in next 2 years
• Current (or anticipated) pregnancy and lactation.
• A pregnancy that was completed less than 6 months prior to screening.
• Breast feeding within 6 months prior to screening.
• Women of childbearing potential who are unwilling to use adequate contraception
• Major psychiatric disorder that, in the opinion of clinic staff, would impede the conduct of RISE
• Additional conditions may serve as criteria for exclusion at the discretion of the local site.

Where it is running

• Childrens Hospital Colorado — Denver, Colorado, United States
• Yale School of Medicine Pediatric Obesity and Type 2 Diabetes Clinic — New Haven, Connecticut, United States
• Indiana University — Indianapolis, Indiana, United States
• Children's Hospital of Pittsburgh of UPMC — Pittsburgh, Pennsylvania, United States

Full record on ClinicalTrials.gov

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